nitrile disposable gloves 510k instructions

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.

EZ-Gloves- nitrile disposable gloves 510k instructions ,EZ-Gloves specializes in non-medical, medical, and industrial disposable gloves. All areas of manuafacturing are managed in accordance to “Good Manufacturing Practices”, ISO 9001, ISO13485, QSR (Quality System Regulations) and SA8000(Social Accountability) and the gloves products are conformed to ASTM, EN455, FDA 510K Number:K162113, and / or any other quality requirements as …Power Free FDA/CE 510K Safety Disposable Medical Nitrile ...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.



INTCO Medical Nitrile Disposable Exam Gloves Thick 100 Pcs ...

Only US$139.80, Shop INTCO Medical Nitrile Disposable Exam Gloves Thick 100 Pcs/box with CE FDA 510K Blue at the Tinkleo Disposable Gloves store. Save up to 50%. We use cookies to improve your online experience. By continuing browsing this website, we assume you agree our use of cookies and Cookie Policy.

Microflex® N64 ONYX Nitrile Examination Gloves, Powder-Free,

These nitrile gloves are ideal for work areas where the job gets messy. This glove is used by workers in automotive, electronics assembly, law enforcement, security environments, tattoo shops and beauty salons. It is 510K approved and can be used in medical applications.

Kimberly-Clark™ Purple Nitrile™ Exam Gloves (55082), 5.9 ...

Your valuable employees deserve the worry-free protection of Kimberly-Clark Purple Nitrile Exam Gloves. These purple nitrile gloves guard against incidental splashes, are made of a highly durable nitrile polymer and are powder free and not made with natural rubber latex (some say “latex free”). The gloves are a 9.5” long, are ambidextrous and have a beaded cuff for easy donning.

FDA 510 k Submission for Latex and Nitrile gloves ...

A 510 k clearance is mandatory for examination and surgical gloves to market in the USA. FDA review time for a 510 k notification is 3 months, but in reality, it may take 6 months or more depends how perfect your 510k documentation is. FDA published guidance documents for latex and nitrile (examination and surgical) gloves 510k submission.

Power Free FDA/CE 510K Safety Disposable Medical Nitrile ...

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.

How to Import Nitrile Gloves | USA Customs Clearance

Mar 27, 2020·Does the FDA Require a 510K For Nitrile Gloves? Nitrile gloves, including for surgical use, are categorized as class 1 medical devices. 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.

Skymed gloves – Just another WordPress site

We are specialized in Disposable Gloves Items, Products & Industrial Products. Our main products include Latex Examination Gloves, Nitrile Examination Gloves, Vinyl Gloves, Surgical Gloves, Latex Gloves, Industry Gloves, PE Gloves… Latex Gloves. 70%. High Risk Latex Gloves…

Power Free FDA/CE 510K Safety Disposable Medical Nitrile ...

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.

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.

IconGlove | Disposable Nitrile and Latex Gloves Manufacturer

The group's ASP for nitrile gloves in its fourth quarter ended Aug 31, 2020 (4QFY20) has more than doubled (103%) from 3QFY20, while on a year-to-year basis, it has increased by 114%. The ASP for nitrile gloves for FY20 as a whole is up 31% from FY19's.

INTCO Medical Nitrile Disposable Exam Gloves Thick 100 Pcs ...

Only US$139.80, Shop INTCO Medical Nitrile Disposable Exam Gloves Thick 100 Pcs/box with CE FDA 510K Blue at the Tinkleo Disposable Gloves store. Save up to 50%. We use cookies to improve your online experience. By continuing browsing this website, we assume you agree our use of cookies and Cookie Policy.

Disposable Glove, Vinyl Glove, PVC Glov, PE Glove - Hongray

Shijiazhuang Hongray Group is the largest manufacturer of disposable protective gloves in the world. Our group has five major production bases in Shijiazhuang, Jinzhou, Xinji, Zanhuang, Shenze of Hebei Province. We produce various vinyl gloves, nitrile gloves, PE and non-woven series products with the annual output of 14 billion pieces of gloves.

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.

510K Powder Free Disposable Nitrile/Latex/Vinyl Gloves 100 ...

Nitrile/Vinyl Gloves Blue, Disposable Nitrile Gloves, Nitrile Material Gloves manufacturer / supplier in China, offering 510K Powder Free Disposable Nitrile/Latex/Vinyl Gloves L/C Sign, Industrial Protective Examination Guantes Powder Free Rubber Safety Latex Nitrile Vinyl Hand Gloves, Disposable Industrial Grade Food Grade Free Powder Latex Exam Nitrile Glove and so on.

510(k) Premarket Notification - Food and Drug Administration

Device Classification Name: patient examination glove, specialty: 510(k) Number: K190159: Device Name: Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove

How to Import Nitrile Gloves | USA Customs Clearance

Mar 27, 2020·Does the FDA Require a 510K For Nitrile Gloves? Nitrile gloves, including for surgical use, are categorized as class 1 medical devices. 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.

Nitrile vs. Latex Gloves: What’s the Difference?

Apr 13, 2020·Nitrile and latex are two of the most common materials for general-use disposable gloves. Before deciding between nitrile vs. latex, there are a few questions to answer: What are nitrile gloves ...

Gloves - LifeScience Inc.

Guardian Nitrile medical grade gloves are powder-free, textured, and are 5 mil thick. Guardian nitrile medical grade gloves are available with a 9 inch cuff. These 510K certified medical grade nitrile gloves are supplied 100 per box, 10 boxes per case.

En455 510K Blue Disposable Powder Free Examination Nitrile ...

Examination Gloves White Color, Green Disposable Nitrile Glove, Nitrile Latex/Vinyl Gloves Examination manufacturer / supplier in China, offering En455 510K Blue Disposable Powder Free Examination Nitrile Gloves, Made in Korea Kf94 Fine Dust Yellow Dust Mask for Adults Large 100 Sheets, Kf94 Yellow Dust Mask Large Made in Korea Individual Packaging Korean Materials 100 …

US FDA 510k and Registration for Gloves - I3CGLOBAL

Sep 21, 2020·510(k) Remarks . 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 infectious materials and other contaminants. OIG

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.

Nitrile Glove - Nitrile Glove inventory in the US with Low ...

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 …

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

Synmax Medical 510k Nitrile Vinyl Blend Exam Gloves - PF, Blue - Large - 100 Per Box

gatamo

Company Profile. Factory introduction. GATAMO group has passed ISO9001 quality management certification,Vinyl and Nitrile gloves have been obtained FDA 510K certificate, EU CE certificate, EN374 test and European food safety test, Nitrile gloves have also passed the CHEMO test.