What are Nitrile Powder Free Examination Gloves?
Nitrile non-sterile examination gloves are versatile in every- day clinical practice and protect personnel from dangerous and harmful substances. Nitrile gloves are resistant to tears, cuts, punctures, abrasives and chemicals, while being a good alternative for individuals allergic to latex.
Q-ARE Nitrile examination gloves tear resistant?
Nitrile examination gloves are particularly tear-resistant and as protection against various puncture injuries.
Do Mediscan Nitrile examination gloves have good grip?
Textured grip surface facilitates optimum instrument manipulation in wet and dry environments, Nitrile examination gloves are very thin and have very good tactile sensitivity.
What makes Mediscan Nitrile 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 examination gloves are impermeable, even to hazardous chemical substances.
Are Mediscan Nitrile Gloves ambidextrous?
Examination 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.
One production Line produces how many gloves per month?
The average Production line produces up to 7.6 million gloves a month.
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.
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
What is the Production time of the Mediscan Gloves?
45-55 days after the receipt of the deposit or LC.
What is the 510K?
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 if the words EXAMINATION or MEDICAL GLOVE is written on the box or a symbol depicting Dental or medical procedures
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 (one Container) upwards.
What is the maximum monthly allocation that would be produced for each order?
The maximum we would allocate to any one purchaser would be 50 million boxes per 30-45 days , Minimum 1 million Boxes
Can we have our own brand?
In order to produce your own brand you would need to order a minimum of 1 billion 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.
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 only, which will be listed on your sale and purchase agreement as production proof. 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.
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.
Do i need a proof of funds (POF)?
We do not accept any PO (Purchase order) with out a Bank certified POF . The POF is the most important document for us to decide if we are prepared to accept the order and issue a quote. For serious customers this is a normal proceedure.
A NDA will be issued after the LOI is accepted so this means the confidenial POF will remain protected. With out a POF ISS Corporation Co Ltd or Mediscan Technologies will proceed with a sale.
What is the production In Time?
60 days from the receipt of your deposit or LC and then shipments every 30 to 45 Days
Can i get CIF delivery?
We only do FOB origin (EXW) we do not facilitate CIF you will need to arrange shipping yourself. however we can arrange all your logistics including , customs clearance, container booking, Ship booking , SGS reports etc
How am i guaranteed my order will be what i purchased?
Simple SGS certify the full process including ensuring the documentation ,packaging, product spec’s meet the agreement before they allow LC draw down or the product to be accepted by the shipping company.
Why do you not divulge or give certifications to agents before the POF is supplied?
What Certifications does Mediscan Gloves apply to production?
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
EN16523-1: 2015+A1: 2018: Permeation by potentially hazardous liquid chemicals under conditions of continuous contact
CE and 510K
All facilities used for the production of Mediscan nitrile and Latex gloves are ISO Certified
All certification is supplied when the allocation of the production slot is complete and the Proof of funds and contract is signed.
Of coarse all contracts are subject to Documents being provided and are not binding until this point. This is because in cases of large orders, sometimes a consortium of factories are used to ensure scheduals are filled and time frames meet .
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 until the slot and schedual is secure.
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 ti 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).
In Fact ISS Corporation issues a rebate of 5 Thai Baht to all imports to the USA for Mediscan Gloves for those importers that import the Glove as general purpose , The 5 Thai baht well compensates any tariffs and speeds up the import of the product.
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 “ .
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 .
What Other 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 product meets requirments , Factory certificates are not required as SGS underwrites the product meets specification as set forth in the agreement.
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’renitrile gloves 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.