fda certificate nitrile gloves

Welcome to Supermax Corporation Berhad :: Quality Assurance

With US FDA on Aurelia Chlorinated Powder Free Latex Medical Examination gloves with Aloe Vera & Ginseng with Protein Labeling Claim (50 mgs or less) FDA 510k registration: With US FDA on Powder Free Nitrile Examination Gloves : FDA 510k registration: With US FDA on Green Peppermint Flavored Powdered Latex Examination Gloves : FDA 510k registration

ABOUT-Nitrile Gloves Group

Our products have passed CE 345/455, FDA 510(K), ISO9001、ISO13485、ISO11193, ASTM D6319、ASTM D5151、ASTM D6124 Certifications. We provide customized exclusive production line services for customers with options of nitrile examination gloves、disposable nitrile gloves and aloe nitrile gloves.

Product Classification - Food and Drug Administration

Device: polymer patient examination glove: Regulation Description: Non-powdered patient examination glove. Definition: A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially ...

CE/ FDA 510K INTCO medical nitrile examination gloves

• FDA 510(K) Available • Approved to use with Chemotherapy Drugs 1.100% latex free-made from durable,puncture resistant, protein and powder- free nitrile,eliminates the Type I allergic reaction associated with natural rubber latex 2.Highly elastic and super soft 3.Rolled rim to facillitate easy donning 4.Designed to give a natural rubber ...

New Patient Examination Glove Available in the SNS - phe.gov

The vinyl/nitrile blend examination glove is a new type of synthetic glove that was developed based on vinyl glove production technology. Its material is compounded with PVC paste and nitrile, so the finished product has the advantage of both materials. The vinyl/nitrile blend examination glove features include: FDA approved though a 510(k ...

Disposable Medical Nitrile Gloves With CE And FDA Certificate

As one of the leading disposable medical nitrile gloves with ce and fda certificate manufacturers and suppliers in China, we warmly welcome you to buy discount disposable medical nitrile gloves with ce and fda certificate in stock here from our factory. All medical products are with high quality and low price. For more cheap products, contact us now.

Medical Gloves for COVID-19 | FDA

Medical gloves are disposable and include patient examination gloves and surgeon’s gloves. To help expand the availability of medical gloves, the FDA is providing regulatory flexibility, as ...

XCYILIAO Disposable Medical Non-strile Power-free Nitrle ...

Only US$7.80, Shop XCYILIAO Disposable Medical Non-strile Power-free Nitrle Gloves with CE FDA 510k at the Tinkleo Disposable Gloves store. Save up to 50%.

Nitrile Gloves Food Grade Certificate - Images Gloves and ...

China High Quality Disposable Latex Gloves Non Sterile Powder Food Grade Nitrile With Ce Fda Certificates Glove And Vinyl. Food Grade Nitrile Gloves Kn 100 280 Mm Blue Exporter From Faridabad. Supertouch Powder Nitrile Gloves Medical Grade Aql 1 5 Conforms To En 455 420 388 374 Box Of 50 Pairs St 12671.


Class I patient Examination Nitrile gloves, Powder Free, LZA, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250. Predicate Device: Legally Marketed Devices to which Substantial Equivalence is claimed: 1) K081260 - KlMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves 5. Device Description :

Certificates - Ansell

Certificates Look-up. Find and download a Certificate of Irradiation (CoI) or Certificate of Processing (CoP) for a sterile BioClean product, or a Certificate of Conformity (CoC) or Certificate of Analysis (CoA) Find Certificate. Contact us for a quality certificate (Certificate of Analysis CoA) for a Microflex product.

FDA Registration of Latex and Nitrile gloves - fdahelp.us

FDA regulate latex and nitrile gloves (examination and surgical) as medical devices. Even though the gloves are class 1 device, it requires FDA 510K Clearance, Medical device establishment registration and device listing to market in the USA.Powdered gloves are not allowed to market in the USA for medical purpose.

FDA 510k Nitrile Gloves Clearance & Certification - I3CGLOBAL

I3CGLOBAL FDA 510k, FDA Registration. Nitrile Examination Gloves are mainly used to protect the wearer and/or the patient from the spread of infection or illness during medical procedures and examinations and are also an example of personal protective equipment. Medical gloves are part of an infection-control plan.

Do Your Gloves Comply with FDA Recommendations and ...

Here's what you need to know when sourcing your FDA-compliant food safety disposable gloves: What is the glove made of? - Part 177. Food contact gloves are certified under FDA Title 21 CFR Part 177, which states that the components of the glove comply with the FDA regulations and the gloves consist of “Substances generally recognized as safe for use in food or food packaging.”