Q-What are Nitrile Composite Powder Free, single use, latex free, disposable powder free Gloves?
Nitrile Composite non-sterile disposable 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 Mediscan Nitrile Composite invention relates to an NBRL (Nitrile Butadiene Rubber Latex) composite material blended with PVC. The Mediscan composite material is prepared from the following raw materials in parts by mass: In reality a Nitrile composite glove consists of NBRL( Nitrile) , PVC and in some cases a variance of 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 have good flexibility under low temperature, and simultaneously have excellent oil resistance and excellent wear resistance. Disposable gloves formulations offering a more suitable gloves are worn for longer periods of time and are 100% latex free and should not be confused with a vinyl glove or similar
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.
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.
One must remember to avoid litigation the words Nitrile 100% should not be used when advertising due to the fact the glove must have accelerator, it must have color, it must have antioxidant and other additives to make the glove practical , In relation to the term sometimes used being that of Nitrile Composite 80% this means that a minimum of 80% of the Mediscan gloves mass is made up of Nitrile and PVC and the remainder being other composites as shown above. therefore legally we at Mediscan feel it would be unethical to use the term 100% Nitrile in advertising.
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 processing packing and logistic plants . ISS Corporation also OEM produces where necessary under license however maintains its own Quality Control.
Q-What Class of conformity is Mediscan Gloves
Mediscan is a Class I nitrile composite ,powder free, non sterile, Disposable, Single use Glove with a thickness of .06>.1mm thick average .08mm
Q-What makes Mediscan Nitrile Powder free Disposable , single usage ,latex free 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?
30-45 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 30 days minimum is the safest time from for delivery . 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 always 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 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 requirements 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.
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 32,000 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 30-45 days , Minimum order 32,000 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 TT of 10% of the entire 24 month order to be paid in Advance, the you would need to pay 40% deposit by TT for each monthly shipment , the balance EXW . These are the only terms we have for OEM. The Reason being is factory production lines are at full capacity until the end of 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 utilizes several production facilities and until payment is received we do not allow video confirmation . Once you TT is in place, 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 Galary section of the Website is frequently 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.
- EN 455-1: 2000
- EN 455-2: 2015
- EN 455-3: 2015
- EN 374-1: 2016
- EN 16523-1: 2015 Permeation: Chemicals Tested for:
- 30% Hydrogen Peroxide
- 37% Formaldehyde
- 40% Sodium Hydroxide
- Acetic Acid
- EN 420: 2003+A1: 2009
- EN 374-2: 2013
- EN 374-4 Degradation: Chemicals Tested for:
- 30% Hydrogen Peroxide
- 37% Formaldehyde
- 40% Sodium Hydroxide
- Acetic Acid
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
- 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?
30 days from the receipt of your deposit with partial shipment 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?
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/
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:
- Packing List: This shows important details about what’s inside of a sealed package including quantity of products, dimensions, weight, and more.
- Bill of Lading: This document serves as a receipt of shipment for the receiver, shipper, and carrier.
- 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.
- Commercial Invoice: Information including value of the goods, HTSUS number, detailed product descriptions, and more are included on the invoice.
- 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 firstname.lastname@example.org.
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 email@example.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 Disposable Nitrile Composite Multi purpose Glove.
Q-For European Community , what Medical or PPE class is Mediscan
As of October 2020 Mediscan is promoted and marketed as a 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 powderless non sterile .
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
Q- What is the difference of a Medical Examination Glove and a Disposable glove?
Simple …Normally there is no difference ,depending on the company and brand owner the gloves normally meet the same EN455 1,2,3 and EN374 1,2,4,5 specifications and testing .Mediscan also meets all of the above and includes the EN420 food grade standards. The difference is Examination gloves are labeled as a medical device. In reality the most governments are starting to reserve the wording “MEDICAL EXAMINATION” for sterile and hospital Medical devices only and should not be sold over the counter. Many o0f the large manufactures are holding the high EN standards however so as not to get caught up in red tap and rapid law changes they have moved labeling to read DISPOSABLE ..
Q- Does Mediscan produce a Pure Nitrile Glove to Examination standards.
The answer is until July 2021 Mediscan has only produced a Composite blend however , ISS Corporation will be producing a Pure Nitrile Glove referred to as the EX-PRO100 series in 2021. This is a pure Nitrile glove (EX-PRO100) that is only available after July 1st 2021 and the cost is significantly higher that the composite which when worn correctly and used correctly do the same job.