fda 510k exam vinyl gloves nitriles

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PPE VGlove - HIC- fda 510k exam vinyl gloves nitriles ,FDA 510K Nitrile Medical Examination Gloves. Specifications: Product ID: VGlove. FDA 510K Premarket Number: K151208. ... MATERIAL: Nitrile (Acrylonitirle - Butadiene), Latex free, Powder Free. FEATURES: Non-sterile, Ambidextrous, Fingertip Textured, Beaded Cuff, Gloves Used For Medical Examination, Free Of Protein ...FDA Registration of Latex and Nitrile gloves - fdahelp.us16 行·FDA regulate latex and nitrile gloves (examination and surgical) as medical devices. Even …



Medical Gloves | FDA

Medical gloves are examples of personal protective equipment that are used to protect the wearer and/or the patient from the spread of infection or illness during medical procedures and examinations.

Tests required for latex and nitrile gloves for FDA 510K ...

FDA Classification for examination and surgical gloves. US FDA Medical Device Labeling Requirements - Gloves. Contents of examination and surgical gloves (Latex / Nitrile) 510k Notification. US FDA 510K Submission Format. FDA publish all 510k clearance on fda website, you can find substantial equivalence letter at www.fda.gov. Below are ...

Nitrile Gloves - FDA 510K, CE-Class 3, ASTM-D-3578, ISO13485

Medical Nitrile Examination Gloves with FDA 410K, CE-Class 3, ASTM-D-3578, EC MARK FOR MEDICAL DEVICES UE 2017/745, and ISO13485.

Manufacturer for Ce Fda Vinyl Gloves - Reflex Blue Nitrile ...

Reflex Blue Nitrile Gloves Nitrile Regular Gloves. Latex Free, No allergy. More exceeding feature of puncture-resistance, anti-bacteria’s penetration, chemical-proof. Durable & Flexible, Surface-textured, Soft feeling, Comfortable donning. Tapered cuff is easy for donning and operating. CE Certification, FDA 510K Listing.

PHS RealFeel – Nitrile Glove, FDA 510K, EN455 – EN374 ...

We build lasting relationships built on trust, respect and accountability. Every interaction is an opportunity to develop a long-term relationship with our partners, employees and customers. PHS is made up of amazing individuals, but it’s only

510(k) Premarket Notification

Jan 18, 2021·Device Classification Name: polymer patient examination glove: 510(k) Number: K200072: Device Name: KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid

Disposable Nitrile Exam Gloves by Szemi-Trade Kft ...

Product Description - Disposable Nitrile Exam Glove - Powder Free Price (USD) - $ 8.50 Delivery - FOB Product origin - Thailand Key Specifications - FDA 510(K), DOC and CE for EN374 Part 1,2,4,5 EN420, EN13563 MOQ - 210,000 boxes Lead Time - 25 to 35 Days Packing - 100 pieces for box S M L and 90 pieces per box for XL Packing - 32,000 boxes per ...

Hongray - Nitrile Exam Gloves - Powder Free - FDA 510K ...

Ambidextrous gloves with a beaded cuff for easy donning and operating. The nitrile exam gloves meet various international standards - FDA 510K, ASTM D6319, ASTM 6978, EN 374, EN 455, CE, ISO 9001, ISO 13485. The gloves are non-toxic, harmless, and

US FDA 510k and Registration for Gloves - I3CGLOBAL

Sep 21, 2020·510(k) Remarks . A latex patient examination glove is a disposable device made of natural rubber latex 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 infectious materials and other contaminants. LYZ: Device Name . Vinyl Patient ...

Skymed - Nitrile Exam Gloves - Powder Free - FDA 510K

What Is a Nitrile Gloves, a Box of Nitrile Gloves, How to Make a Nitrile Gloves manufacturer / supplier in China, offering Skymed - Nitrile Exam Gloves - Powder Free - FDA 510K, Made in Korea Kf94 Fine Dust Yellow Dust Mask for Adults Large 100 Sheets, Standard Powder Free Blue Nitrile Gloves …

510(k) Summary Latex Examination Gloves Powder Free …

510(k) Summary Latex Examination Gloves Powder Free 1.0 Submitter:JU1G20 Company Name: ... requirement of ASTM D 3578-05 and FDA 21 CFR 880.6250. Section 2A- 1. Appendix 2 4.0 Description of Device Latex Examination gloves powder free as described in this 5 10(k) Notification is substantially equivalent to the current class I patient ...

510(k) Premarket Notification

Jan 18, 2021·Device Classification Name: polymer patient examination glove: 510(k) Number: K200072: Device Name: KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid

Appendix III. 510(k) Summary

Feb 19, 2008·Latex Examination Gloves (pre-powdered and powder free) Nitrile Examination Gloves (pre-powdered and powder free) Classification Name: Glove, patient examination, latex Glove, patient examination, poly Device Class: I Product Code: LYY & LZA Regulation Number: 880.6250 Intended Use: A patient examination glove is a disposable device intended ...

Manufacturer for Ce Fda Vinyl Gloves - Reflex Blue Nitrile ...

Reflex Blue Nitrile Gloves Nitrile Regular Gloves. Latex Free, No allergy. More exceeding feature of puncture-resistance, anti-bacteria’s penetration, chemical-proof. Durable & Flexible, Surface-textured, Soft feeling, Comfortable donning. Tapered cuff is easy for donning and operating. CE Certification, FDA 510K Listing.

Synmax Medical 510k Nitrile Vinyl Blend Exam Gloves - PF ...

Synmax Medical 510k Nitrile Vinyl Blend Exam Gloves - PF, Blue - Large - 100 Per Box Related Products; Customers Also Viewed; ... (FDA-Approved Medical Use) Disposable - 50 Count. $10.97. As low as $8.56. Quick view Add to Cart. 293. Quick view Choose Options. Hand Sanitizer Gel (3.38oz, 100ml) (75% Ethanol Alcohol, FDA Approved) ...

510(k) Premarket Notification

Jan 18, 2021·Device Classification Name: polymer patient examination glove: 510(k) Number: K200072: Device Name: KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid

Nitrile Exam Gloves | Powder-Free Nitrile Gloves | Tronex ...

Additionally, all Tronex chemotherapy-rated nitrile exam gloves meet and exceed ASTM D6978 Resistance of Medical Gloves to Permeation by Chemotherapy Drugs with FDA 510(k) Approved for Medical Use. 9128 Series Nitrile “NEW AGE®” Chemo-Rated, Powder-Free, Fingertip-Textured Exam Gloves

China Nitrile Gloves for Examination Room with FDA 510K ...

Nitrile Gloves, Disposable Nitrile Gloves, Nitrile Glove manufacturer / supplier in China, offering Nitrile Gloves for Examination Room with FDA 510K, Foldable Noish N95 Face Mask, Eua Approved KN95 Mask KN95 Respirator and so on.

510(k) Premarket Notification

Jan 18, 2021·Device Classification Name: polymer patient examination glove: 510(k) Number: K193581: Device Name: Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with …

Discount Nitrile Exam Disposable Gloves with FDA + 510K ...

Discount Nitrile Exam Disposable Gloves with FDA + 510K- 4mil, Powder Free, Blue, Skymed Not Made in China, Find details and Price about China What Is a Nitrile Gloves, a Box of Nitrile Gloves from Discount Nitrile Exam Disposable Gloves with FDA + 510K- 4mil, Powder Free, Blue, Skymed Not Made in China - Nanjing Angela Accessories Co., Ltd.

OMak Nitrile Powder-Free Examination Gloves

Our Glove are ideal for those who love reliable protection with great skin alike comfort and reduced fatigue in your hand. It is designed to provide a reliable solution to cover all application areas. OMak Nitrile Powder-Free Examination Gloves, FDA 510(k), EN 455, LC.

CE/ FDA 510K INTCO medical nitrile examination gloves

• FDA 510(K) Available • Approved to use with Chemotherapy Drugs 1. 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 ...

FDA 510(k) Applications Submitted by ANSELL, INC.

ansell denta gloves: ansell, inc. k903107: 07/09/1990: patient exam gloves (dusted w/usp starch powder) ansell, inc. k913766: 08/22/1991: ansell no powder ambi patient examination gloves: ansell, inc. k897081: 12/19/1989: ansell conform green examination gloves: ansell, inc. k953379: 07/19/1995: hypoallergenic powdered ambidextrous coagulatn ...

(Vinyl Patient Examination Glove) - FDA 510(k ...

stretch vinyl examination glove, powder free (yellow/white) 05/18/2009: k090513: shandong huayue glove co., ltd. vinyl examination glove, powder free clear (non-colored) 05/08/2009: k111752: shandong jianhong new material company: powder free vinyl patient examination gloves, clear (non-colored) 07/27/2011: k023235: shandong jiazhan plastic ...