Q-What are Nitrile Composite Powder Free disposable powder free General Purpose Gloves?

Nitrile Composite non-sterile disposable General purpose gloves are versatile in every- day practice and protect personnel from dangerous and harmful substances. Nitrile Composite gloves are resistant to tears, cuts, punctures, abrasives and chemicals, while being a good alternative for individuals allergic to latex.

The invention relates to an NBRL (Nitrile Butadiene Rubber Latex) composite material. The NBRL composite material is prepared from the following raw materials in parts by mass: approximately 70% of NBRL( Nitrile) and a PVC composite for resistance , 0.2 to 10 percent of surfactant, 0.1 to 5 percent of vulcanize, 0.1 to 10 percent of vulcanizing accelerator, 0.5 to 5 percent of antioxidant, 1 to 5 percent of low-temperature plasticizer and 2 to 8 percent of tackifier. The invention also relates to low temperature-resisting butyronitrile gloves prepared from the NBRL composite material. The butyronitrile composite gloves (70%) with small added PVC percentager have good flexibility under low temperature, and simultaneously have excellent oil resistance and excellent wear resistance. General purpose gloves formulations offering a more suitable glove worn for longer periods of time very normally from 60% to 70% Nitrile with PVC Composite and are 100% latex free.

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Latex gloves are often preferred by healthcare providers since they provide the best service when it comes to elasticity, comfort and fit. Surgeons in particular benefit from latex gloves since they are great for sensitive work, since they offer more precision with high tactile sensitivity.

Despite its advantages, latex gloves have become an issue for many health professionals due to the increasing rate of latex allergies, and many are choosing to go with non-latex glove options such as vinyl and nitrile gloves instead.

Vinyl gloves, which are made from PVC (polyvinyl chloride), are  the most common latex-free gloves. However, many prefer to use higher-end gloves such as nitrile gloves. Nitrile gloves are often preferred since these non-latex gloves best resemble the stretchy feel of latex gloves.

The difference to consider when deciding between latex and latex-free gloves is the protection offered by each type of material. In general, latex gloves offer the best protection against bacteria and viruses, while synthetic gloves provide better chemical protection. Of the different types of latex-free gloves, nitrile Composite mixture gloves offer a higher degree of protection against viruses, besides the chemical protection they provide.

Q-Does Mediscan have its own factory and is it partnered with other companies

First of all Mediscan is owned by ISS Corporation Co Ltd and is not partners with any other glove manufacturing  company or supplier in Thailand, . Currently Mediscan is in the process of developing its own facility due to be completed in Mid 2021. Until this time ISS Corporation OEM produces under licenses and maintains its own Quality Control.

Q-What Class of conformity is Mediscan Gloves

Mediscan is a Class I general purpose nitrile composite ,powder free, non sterile, Disposable, Single use Glove with a thicknes of .08>.11 mm thick average

Q-What makes Mediscan Nitrile Powder free Disposable General Purpose Gloves different from others?

The anatomical fit improves comfort during wear and extends the wear timeA good alternative for individuals allergic to latex. Unlike latex gloves, nitrile Composite Powder free Disposable General Purpose gloves are impermeable, even to some hazardous chemical substances.

Q-Are Mediscan Nitrile Gloves ambidextrous?

Powder free Disposable General Purpose gloves are ambidextrous, have an extra long cuff (min. 240 mm) with a comfortable edge that facilitates putting on and taking off and securing onto the hand.

Q-One production Line produces how many gloves per month?

The average Production line produces up to 7.6 million gloves a month.

Q-How Many gloves fit in a box?

For sizes of S,M,L there are 100 gloves per box, for Size XL there are 90 gloves per box, each carton has 10 boxes.

Q-How Many Gloves Fit in a Container?

40 foot (HC) container = 3200 cartons (36cm x 23cm x 23cm ) each containing 10 boxes (100 gloves each with the exception of XL being only 90 gloves) this totals 32,000  boxes (3200 Cartons) per 40 foot container.  most buyers do not use pallets as they can sometimes damage boxes .                                                               If Pallets are required , the following is standard information:  A Standard wooden pallet 48″ x 40″ X 6″ or 122cm x 102 cm x 15cm with a static load bearing capacity of 3 short tons (2.7 long tons,2.7 t and a 1-short-Ton (0.89-long-ton,0.91t)  Dynamic capacity, will weigh approximately 33 to 48 lb (15 to 22 kgs)

Weight per box of 100 gloves = 540g

weight per carton of 10 boxes = 6 kilo inc carton

Q-What is the Production time of the Mediscan Gloves?

60-90 days after the receipt of the deposit or LC. Product curing is important to quality.

The Nitrile Industry is often hampered with delays due to raw material shortages , labor and logistic problems so 60 days minimum is the safest time from for deliviery . Once the ISS Corp plant comes online then these times will shorten has Mediscan will no longer need to rely on third parties to secure deliveries from providers.

In this business allways expect delays and never book ships until you have been notified that your shipment is in the out going goods bay.

Q-What is 510K and is it required to import Mediscan Gloves ?

 510(K) is a pre-market submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to pre-market approval. 510k is only required MEDICAL GLOVE is written on the box or a symbol depicting Dental or medical procedures. Mediscan Powder free Disposable General Purpose glove currently come under the Pandemic FDA waiver system allowing importers to import providing they are from a FDA registered Owner Operator company. To ensure the Product meets waiver requirments the box must state the wording : DISPOSABLE, SINGLE USE , POWDER FREE, GENERAL PURPOSE

When purchasing Mediscan Gloves you need to understand Clearly that ISS Corporation is Registerted with the USA FDA as an Owner Operator and operates under the 510K waiver system . the waver system gives the same privilages as the initial 510K system before COVID 19.

This guidance is being issued to address the Coronavirus Disease 2019-2021 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.
B. Gloves Not Intended for a Medical Purpose Gloves are devices when they meet the definition of a device set forth in section 201(h) of the FD&C Act. Under section 201(h) of the FD&C Act, these products are devices when they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease.
Other gloves are marketed to the general public for general, non-medical purposes, such as use in construction and other industrial applications. Because they are not intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, FDA device marketing authorization is not required, and all the other requirements of the FD&C Act do not apply to manufacturers, importers, and distributors of these products.
C. Patient Examination Gloves A non-powdered patient examination glove is a disposable device intended for a medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner.23 A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing. These devices are class I (reserved) and subject to premarket notification requirements under section 510(k) of the FD&C Act because general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device and the devices are intended for a use which is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury, under sections 513(a)(1)(A) and 510(l)(1) of the FD&C Act. In general, FDA recommends that health care providers follow current Centers for Disease Control and Prevention (CDC) guidance regarding PPE that should be used during the COVID-19 outbreak.24 Health care employers must also comply with standards of OSHA that require PPE to protect workers and that apply to infectious disease hazards.
25 FDA recognizes the urgent need during the COVID-19 public health emergency for patient examination gloves due to increased use and demand which has led to shortages in their availability. To help ensure the availability of these devices during the COVID-19 public health emergency, FDA does not intend to object to the distribution and use of patient examination gloves that do not comply with the following regulatory requirements, where the gloves do not create an undue risk in light of the public health emergency

Purchasers Mediscan Gloves are priviladged as a 3.5% discount is built in to all pricing for purchasers entering the USA to off set any imposed tarrifs that may arise in the future.

The most important thing to remember is that Mediscan Gloves are not Medical Examination Gloves and should be decleared as General purpose ,Disposable, single use ,powder free.

Q-What is the Min MOQ?

MOQ means minimum Order Quantity. The MOQ is based on the current status at the time of our allocated production facilities and OEM companies ability and orders , normally MOQ for corporate sales are 96,000 Boxes (three Containers) upwards.

Q-What is the maximum monthly allocation that would be produced for each order?

The maximum we would allocate to any one purchaser would be 12 million boxes over a 12 month period withb partial shipments starting 60-90 days , Minimum order 160,000 boxes

Q-Can we have our own brand?

In order to produce your own brand you would need to order a minimum of 12 million boxes over a 24 month period, the entire order would require to be secured by LC with a 30% of the entire 24 month order to be paid via LC Advance (Red Clause). These are the only terms we have for OEM. The Reason being is factory production lines are at full capacity until 2021 and to modify packaging etc is a very expensive process and we cannot risk the order stops or customer cancels before they have received the entire committed order.

Q-Can we receive Video's with signs displaying our name in the production facilities?

Due to the fact that Mediscan utilises several production facilities and until the LC or payment is received we do not allow video confirmation . Once you LC is inplace, we will arrange a video and photos of a ISS Corporation staff member displaying your order number when your product is in the dispatch zone of the factory warehouse ready for shipping only. The reason we will not and do not issue video’s before this as Agents and brokers use them to sale or on sale contracts.

Our gallary section of the Website is fequently updated with photos and videos

Q-Can i purchase with a Escrow or any other terms that are not listed in the company's terms of purchase?

No we do not negotiate terms due to the fact that it is a high in demand product with waiting lists of purchasers.

Q-What EN tests are preformed for quality control of Mediscan Gloves

Please Note official testing is not required for a Class I general purpose Glove , however ISS Corporation tests the following not to certify Mediscan gloves as a medical examination Glove but to ensure distributors and customers of the standards we use to manufacture our general purpose disposable Gloves.

 

  1. EN 455-1: 2000
  2. EN 455-2: 2015
  3. EN 455-3: 2015
  4. EN 374-1: 2016
  5. EN 16523-1: 2015 Permeation: Chemicals Tested for:
  • 30% Hydrogen Peroxide
  • 37% Formaldehyde
  • 40% Sodium Hydroxide
  • Acetic Acid
  • Methanol
  • Isopropanol
  1. EN 420: 2003+A1: 2009
  2. EN 374-2: 2013
  3. EN 374-4 Degradation: Chemicals Tested for:
  • 30% Hydrogen Peroxide
  • 37% Formaldehyde
  • 40% Sodium Hydroxide
  • Acetic Acid
  • Methanol
  • Isopropanol
    EN 374-5: 2016

 

10.Food Contact Test: Food Grade US. FDA 21 CFR 177.2600

  • Water Extractives (For contact with aqueous food): US FDA 21 CFR 177.2600
  • N-hexane Extractives (for contact with Fatty food): US FDA 21 CFR 177.2601

 

  1. Overall Migration
  • Overall Migration in 3% Acetic Acid Extraction: Council of Europe Resolution AP (2004) 4: (EN 1186-1) – Rubber
  • Overall Migration in 10% Ethanol Extraction: Council of Europe Resolution AP (2004) 4: (EN 1186-1) – Rubber
  • Overall Migration in 20% Ethanol Extraction: Council of Europe Resolution AP (2004) 4: (EN 1186-1) – Rubber
  • Overall Migration in 50% Ethanol Extraction: Council of Europe Resolution AP (2004) 4: (EN 1186-1) – Rubber
  • Overall Migration in fatty Foods Substitute – 95% Ethanol: Council of Europe Resolution AP (2004) 4: (EN 1186-1) – Rubber
  • Overall Migration in Fatty Food Substitute – Isooctane: Council of Europe Resolution AP (2004) 4: (EN 1186-1) – Rubber

Q-What is the production In Time?

60 days from the receipt of your deposit or LC with partial shippment allowed

Q-Can i get CIF delivery?

We only do  origin (EXW) we do not facilitate CIF you will need to arrange shipping yourself. however we can arrange all your logistics including , Origin customs clearance, container booking, Ship booking , SGS or TUV loading reports etc

Q-What should i declare my shipment as?

Simple … you need to make sure your shipping company and reciever are familiar with the requlations. Because Mediscan is General Purpose Class I Disposable it is a relitivly simple process.

1/ Make sure all documents state the words “General Purpose, Disposable, Single use, Non Latex , Non Sterile Blue Glove”

2/ Make sure the recieving party delares the product as “General Purpose, Disposable, Single use, Non Latex , Non Sterile Blue Glove”.

3/ Make sure the Preformor Invoice states “General Purpose, Disposable, Single use, Non Latex , Non Sterile Blue Glove”.

4/ Make sure all your advertising states “General Purpose, Disposable, Single use, Non Latex , Non Sterile Blue Glove”.

5/ Make sure all declarations state “General Purpose, Disposable, Single use, Non Latex , Non Sterile Blue Glove”

General Purpose Class I do not require 510K and can uterlize the Waiver System , for entering the EU or EC terratories only a certificate of conformity is normally required.

Q-Why do you not divulge or give certifications to agents before the POF is supplied?
This is a very good question, the reason is that there are many agents and Internet Traders that collect documents to try and on sell or solicit buyers, sometimes promising quota’s that cannot be delivered, they use these documents to shop with so to speak .
All genuine clients have no problem issuing a POF which is protected with an NDA If they are genuine and in a position to purchase .
Our production lines are at maximum capacity and we can only allocate quoters that we have available  therefore we do not want agents passing our papers on to potential clients that may not be in a position to purchase or soliciting quota’s that cannot be meet.
However one of the main reasons is that Mediscan Nitrile Powder free Disposable General Purpose Gloves are manufactured in several contracted OEM factories to insure we meet our production scheduals . therefore until we recieve your LOI and a proof of funds it would be impossible to allocate which of our contracted factories we would use as it will be based on your order and requested delivery time and the product destination, so until we agree to take the order we do not issue documents to every inqury re receive.
Also Mediscan Gloves are General purpose and we do not sell or export them as a Medical device therefore only the declaration of conformity is required and suppied with the USA Owner Operator number as reference.
Q-What Certifications does Mediscan Powder free Disposable General Purpose Gloves apply to production?

Mediscan Nitrile Powder free Disposable General Purpose glove are produced the the following standards ,how ever are classed and marketed as General Purpose Disposable General purpose Non Sterile Class I glove meaning only the declaration of conformity is providied .

However when you Scan the QR code of a mediscan box you gain access to all the technical data , We also supply the following test results as of April 10th 2021

EN 455 1-2-3-4

EN ISO 374-1:2016+A1:2018: Terminology and performance requirements for chemical risks

EN ISO 374-2: 2019: Determination of resistance to penetration
EN ISO 374-4:2019: Determination of resistance to degradation by chemicals
EN ISO 374-5:2016: Terminology and performance requirements for micro-organisms risks

Currently Mediscan General Purpose Powder free Disposible gloves are registered under the USA FDA Owner/Operator manufacture number 10080319 and are currently imported under the 510K Waiver system

 

Untill the ISS Corporation Facility is fully operational in May of 2021 All products are supplied by consortiums and manufactured in facilities in China , Malaysia ,Thailand , all products used for the production of  Mediscan nitrile and Latex gloves are tested by each facility to meet the standards ISS Corporation requires for its products.

All certification is supplied direct from the suppliers or consortiums with shipments. Because of the FDA 510K waiver only the FDA Owner operater number and a certificate of conformity by ISS Corporation is required to enter into the USA.

Due to the Mediscan Glove being discribed as General purpose Disposible ,Powder free, single use it does not require documentation to enter in to the EU comunity providing when shipped it is clearly marked as disposible non medical.

In some cases up to 4 different factories maybe used to complete a single order. This means it would be un productive to supply certification every plant and being General Purpose it is not required.

Q-Does Mediscan Nitrile Gloves Require 510K

The answer is , it depends on the Packaging , Mediscan packaging nowhere states the words MEDICAL EXAMINATION , Therefor does not require 510k to import

US Customs states that Nitrile Powder Free (non sterile)  gloves are not distinguished from those  HQ 964826. It is understood that the advertising, marketing, channel of sale and package marking all indicate a non-medical use for this glove.

The applicable subheading for the nitrile gloves will be 4015.19.1010, Harmonized Tariff Schedule of the United States (HTS), which provides for disposable, seamless rubber gloves: non-surgical. The rate of duty will be 3 percent ad valorem.  

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

Nitrile gloves, including for surgical use, are categorized as class 1 medical devices if they are packaged as Medical Examination Gloves. This means they’re regulated by the FDA and require a 510(k) premarket notification. The FDA reviews the gloves to insure that they meet specific criteria related to safety and performance.

It’s important to note that it is the production facility that must be registered as the 510K license holder and issued the 510K number not the Brand, many nitrile gloves  have already received approval through a 510K under a production facility as the brand is owned by the factory or secured under OEM agreement , either are accepted by the US Customs providing clear OEM documents are provided if requested by customs officials. If you’re importing nitrile gloves that have already been approved , then you won’t need to go through the 510K process. You’ll simply need to reference the 510K production facility to show the gloves you’re importing are Manufactured under OEM license by a 510K certified facility.

510k is not required for non medical use Nitrile Powder Free (non Sterile) Gloves used for general purpose ,providing the packaging does not carry  the words “Medical” or “no Examination “ .

Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency https://www.fda.gov/media/136540/download a with certain labeling conditions, waives premarket notification(510k), registration and listing and other requirements. The new Enforcement Policy will remain in effect only for the duration of the public health emergency. Medical Gloves for COVID-19
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-gloves-covid-19#import-purchase-donate

Q-What is the Import Duty for Nitrile Gloves?

Nitrile gloves are part of a larger group of medical gloves (If Advertised as a Medical Exsamination Glove on packaging) that includes examination gloves and special chemotherapy gloves designed specifically for handling chemotherapy products. All of these gloves are considered personal protective equipment, according to the U.S. Food and Drug Administration. These medical gloves aid healthcare workers and patients by protecting their hands from infectious germs in places and situations when infection is likely.

Currently there is no import duty on nitrile gloves imported into the U.S. however this may change at the US Govt discretion . 

Q-What Documents Are Needed When Importing?

Other documents you’ll need when importing include:

  1. Packing List: This shows important details about what’s inside of a sealed package including quantity of products, dimensions, weight, and more.
  2. Bill of Lading: This document serves as a receipt of shipment for the receiver, shipper, and carrier.
  3. Arrival Notice: This document is required to be transmitted electronically to customs officials prior to arrival in the U.S. A paper copy that matches the electronic data should also accompany the shipment and is supplied by you logistics company.
  4. Commercial Invoice: Information including value of the goods, HTSUS number, detailed product descriptions, and more are included on the invoice.
  5. Copy of SGS or BV report certifying the the loading and sealing of the container and its quantity , Factory certificates are not required for General Purpose gloves Class I.

Missing or inaccurate documents can lead to a delayed shipment or unplanned customs fees. USA Customs Clearance will work with you to make sure your import shipment has all of the required documentation. Whether you’r nitrile gloves,Latex gloves, or another critical need product, US customs works hard to ensure your goods arrive quickly and without issue. Note the clearence proceedures are mostly facilitated enroute to the desination to prevent port conjestion when unloading and fast track clearence. For Entryu into the USA General Purpose Disposable Class I me enter under the waiver system if the Seller is a registered Owner Operator with the USA/FDA

 

Q-Is ISS Corporation Co Ltd part of any joint venture or partnership

ISS Corporation Co Ltd , has no partnership with any Thai entity .

Q-Should I buy from an Distributor or By Direct from ISS Corporation

The desision is yours, however do your due diligence , contact us before signing to ensure you are dealing with a real distributor. Buying from a distributor is no problem providing you have done your due dilligence .

Remember if you pay a distributor direct with out confirming the terms with ISS corporation then it is your responsibilty .

 

Q-When buying from a third party of agent what should i be careful of?

First of all most our official distributors are listed with thier logos on our website , if you dont see your sweller there then you should verify with ISS Corp on legal@issworldwide.com.

1-ISS Corporation does not issue fixed schedules for delivery until the new plant opens in May of 2021. All deliverys are based on ability of Raw product (NBR) etc so if a distributor has made promises for delivery you should contact ISS Corporation Co Ltd for confirmation on sales@issworldwide.com.

2-ISS Corporation takes no responsability for undertakings of third parties including Agents or Distributors.

3- ISS Does not accept LCs  that have already been transfered 1 time or used as security to issue a back to back LC from a master LC.  ISS Corporation Co Ltd accepts SBLC with EXW terms,

4- Promises of production are not issued by ISS Corporation Co Ltd until the new facility is open in 2021

5- Mediscan nor ISS Corporation production facilities are not operational as yet and all purchases are through consortiums nuntil the time the new facility is operational.

6-Mediscan Gloves are General Purose Nitrile Disposable Single Use Non sterile, they are not Medical Examination Gloves. However they are manufactured to the same standards of a medical examination glove but not certerfied as such.

7- Have you been promised certificates from an agent or third party? ISS Corp does not offer certification nor certificats other than a Declaration of conformity. Certification is not required for General Purpose Gloves.

8-ISS Corporation does not issue allocation letters nor does it asign quotas to third parties. All orders are based on partial shipment at the availibility of product.

9-If an Agent has instructed you to book logistics , you should require confirmation that you product is on the dispatch floor of the warehouse before doing so. ISS Corporation does not inform clients to book logisticts until official written confirmation stating PO number is issued.

10- If an agent tries to pass on Mediscan Gloves as a Medical Examination Glove with PPE certification past January 2021 this is not correct and false information. Mediscan is a General Purpose Powder free disposable single use glove not a Medical examination glove even though it is manufactured to the same standards.

 

Q-Why does the Mediscan Box not show the word "EXAMINATION"?

In December of 2020 to meet USA FDA Waiver Conformity and EC conformity as a Class I PPE glove the word was removed from all advertising , originally Mediscan was referred to as GENERAL PURPOSE  EXAMINATION GLOVE POWDER FREE DISPOSABLE, from 22 November 2020 the word EXAMINATION was removed from all media and advertising to avoid confusion and insure a clear understanding that Mediscan is a General Purpose Nitrile Composite Multi purpose Glove.

Q-For European Community , what Medical or PPE class is Mediscan

As of October 2020 Mediscan is promotedc and marketed  as a Genertal Purpose Disposable Single use Nitrile Glove under Class I of the European Union standard

In the USA Mediscan is a Disposable single use non latex glove that is classed as general purpose .

Does the box have CE logo and what CE document is required for Class I PPE

CATEGORIES OF PPE
The route to conformity of PPE is determined by the category it falls into which it falls. PPE is split into three categories as defined below The Regulation does not officially define the three categories but it is common practice to refer them as below:

– Category I: PPE intended to protect users against minimal risks, as defined by the exhaustive list in Annex I;

Class I only requires a Self Declaration from the Seller or Brand Owner confirming the manufacture standard and the availability for purchasers to view instructions on how to use the product and or online specifications accessed via website or QR Code system. No other documents are required for Class I . When the process has been completed the ‘CE’ can then be affixed

– Category II: Equipment falling into neither Category I or Category III;

– Category III: PPE intended to protect users against very serious risk such as death or irreversible damage to health as defined by the exhaustive list in Annex I

For Class II-III EC type Certification is required , including Manufactures declaration of Conformity , Production Quality Monitoring system certification, EC quality control system , Satra 2777 or similar