medical nitrile gloves 510k medical devices

High Elasticity:
Stretch Resistance

Thick Design:
Puncture Resistant

Sealed &Waterproof:
Care for Your Hands

Latex and allergy free:

These gloves have latex free materials that are useful for those people who have allergy to the latex. 

Puncture resistant:

Nitrile gloves are specifically manufactured in a puncture-proof technology. 

Full-proof sensitivity:

These are produced to fulfill sensitivity requirements.

Importing Medical Gloves to the USA: Info & Regulations ...- medical nitrile gloves 510k medical devices ,Jun 15, 2020·In addition, there are non-medical gloves such as ‘embalming gloves,’ or ‘food service gloves.’ These are not medical devices, so be aware to not import these for use in medical settings fighting COVID-19. Read more about these in the FDA medical glove guidance manual, if you like.510(k) Premarket NotificationJan 18, 2021·510(k) Premarket Notification. FDA Home; Medical Devices; Databases ... Back To Search Results: Device Classification Name: polymer patient examination glove: 510(k) Number: K983334: Device Name: NITRILE POWDER FREE EXAMINATION GLOVES: Applicant: CRANBERRY (M) SDN. BHD. LOT 85, JALAN PORTLAND, TASEK INDUSTRIAL ESTATE: ipoh perak, MY 31400 ...



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China Power Free FDA/CE 510K Safety Disposable Medical Nitrile Gloves, Find details about China Nitrile Gloves, Safety Gloves from Power Free FDA/CE 510K Safety Disposable Medical Nitrile Gloves - Anhui Link-Tech Security Equipment Co., Ltd.

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HUAYI Nitrile Gloves - Medical Devices1.com

Country: China: Delivery Time: lead time20 to 30days: Price: $85.50 a carton of 1000 gloves packed in box of 100s: Quantities: 13000 boxes of a 100: Type:

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

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FDA Relaxes Enforcement Policies for Medical Gowns and Gloves

FDA will look carefully at product labels to determine if medical device claims are being made. Medical Apparel and Gloves. FDA will allow gowns, other apparel and gloves, during this emergency, to be imported without prior 510(k) filings, facility registration and listing requirements, Quality System Regulation (QSR) requirements, or Unique ...

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We also have different manufacturers of Nitrile Gloves from overseas and US manufacturing partners. At this price point of $0.14 per Nitrile Glove, the Minimum Order Quantity (MOQ) is 50,000 pieces. This Nitrile Glove inventory complies with FDA 510K, ISO 9001: 2015, ASTM-D-3578, EN455 PART 1 …

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Nitrile Gloves 510K. SKU: 8-50018-92702-4 Category: Products. Description Additional information Reviews (0) Description. Made in Thailand. 4.7 mil thickness. Blue, with small quantity of green and purple color. 100 count boxes. 510K FDA medical certified. Sizes S, M, L. Arrives 25 June.

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FDA Relaxes Enforcement Policies for Medical Gowns and Gloves

FDA will look carefully at product labels to determine if medical device claims are being made. Medical Apparel and Gloves. FDA will allow gowns, other apparel and gloves, during this emergency, to be imported without prior 510(k) filings, facility registration and listing requirements, Quality System Regulation (QSR) requirements, or Unique ...

NITRILE GLOVES - Medical Devices1.com

Material: <p>NON-LATEX</p> Certification: <p>CE</p> Features: <p>Powder and latex free gloves minimise the risk of contamination and allergic reactions<br><br>Snug fit ensures user dexterity and sensitivity<br><br>Ideal for more complex and precise applications<br><br>Basic protection from unwanted and dangerous substances<br><br>Beaded cuff ensures easy donning and prevents liquid …

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Jan 18, 2021·polymer patient examination glove: 510(k) Number: K192444: Device Name: mCare® Powder Free Nitrile Black Examination Glove: Applicant: Mercator Medical (Thailand) LTD. 88/8 Moo 12 Tambon Kampaengphet: amphur rattaphum, TH 90180 Applicant Contact ... Regulation Medical …

Synmax Vinyl Nitrile Hybrid Medical Exam Gloves

Synmax Vinyl Nitrile Hybrid Medical Exam Gloves. The benefits of nitrile. The pricing and durability of vinyl. Revolutionary new formulation of vinyl-based hybrid material, containing nitrile, with elastic and strong “bones” with enhanced tactile sensitivity and a practical barrier of protection for a wide range of applications. They are ...

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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

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Gloves – Alliable Medical

Nitrile Gloves. Alongside our latex glove, Alliable Medical offers a Non-Sterile Powder Free Nitrile Glove that is FDA 510K cleared and proved to be the standard for the highest quality. Certifications: FDA 510K Cleared IISO 9001:2008 ISO 1345:2003 IISO 22000: 2005 CE Marking Our glove is offered in (4) sizes : Small, Medium , Large, X-Large.

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510(k) Premarket Notification

Jan 11, 2021·Device Classification Name: polymer patient examination glove: 510(k) Number: K192635: Device Name: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)

Nitrile Exam Gloves Medical – 510K - ABOBTECH CO.,LTD

ABOB Nitrile Exam Gloves. Medical – 510K. Overview • Class I Medical Device • Nitrile Medical Exam • Blue • Non-sterile • Powder free • Beaded cuff • Ambidextrous • Single use. Product Description Certification. Related Products. Pure Nitrile Gloves …

AIM-X Proposal for MEDICAL NITRILE GLOVES AIM X GDIH

5Gram weight, Medical Grade Nitrile gloves Latex Free Disposable Powder Free Non-Sterilized EN455 EN374 AQL 1 Medical Nitrile Gloves (Non-Sterile) 5 Grams not Ordinary 3.5 grams Specification 9”5.0gram Length >230mm Width 100+-3 Thickness Cuff .mm Palm .11mm Finger .13 mm