disposable nitrile gloves blue 510k form pdf

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.

Gloves - LifeScience Inc.- disposable nitrile gloves blue 510k form pdf ,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.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.



How to Import Nitrile Gloves | USA Customs Clearance

Mar 27, 2020·It's important to note that many nitrile gloves have already received approval through a 510K. 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 to show the gloves you're importing have already been approved.

KleenGuard™ G10 Blue Nitrile Gloves (57373), Large, Powder ...

KleenGuard™ Personal Protective Equipment (PPE) enables rather than inhibits – allowing for maximum productivity and safety for you and your employees. Your employees are your most valuable asset, and KleenGuard™ G10 Blue Nitrile Gloves help keep them safe. These top-selling protective gloves are resistant to oils and splashes, making them a great choice to help protect your team.

KleenGuard™ G10 Blue Nitrile Gloves (57373), Large, Powder ...

KleenGuard™ Personal Protective Equipment (PPE) enables rather than inhibits – allowing for maximum productivity and safety for you and your employees. Your employees are your most valuable asset, and KleenGuard™ G10 Blue Nitrile Gloves help keep them safe. These top-selling protective gloves are resistant to oils and splashes, making them a great choice to help protect your team.

Nitrile Disposable Gloves - Disposable Latex Gloves ...

For everyday tasks that require single-use work gloves, Magid Glove & Safety provides disposable nitrile gloves/latex gloves for any work application. Disposable nitrile gloves/latex gloves are used in a variety of applications, including chemical processing, medical, paint manufacturing, metal treatment, inspection and quality control ...

Product Information

510(k) Number (ifknown) Kl7l 22 Device Name Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color Indications for Use (Describe) The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is

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.

SAFETY DATA SHEET - WebstaurantStore

Trade name: Nitrile Disposable Powder Free Glove ... Nitrile gloves may induce stray cases of skin irritation in some individuals. · Safety phrases: ... • FDA 510K • EN 455 (1,2 &3) • ASTM D3578-95 • ASTM D3577-91 • FDA 21 CFR 177.2600 food grade contact

Medical Glove Guidance Manual | FDA

This manual provides FDA’s recommendations for Premarket Notification (510(k)) submissions for medical gloves. It also provides our recommendations on how to comply with the Quality System ...

Nitrile Gloves

A disposable Nitrile examination glove. A great alternative to latex gloves, latex-free nitrile gloves offer quality resistance to chemicals and have a form-fitting design to prevent gloves from falling off while in use. Available in different colors, to prevent confusion in the workplace. - Textured Fingertip - Powder free - No Natural Latex

Disposable Nitrile Gloves - Blueflame Medical

Disposable Nitrile Gloves are a critical piece of personal protective equipment (PPE.) Used during medical procedures and examinations, nitrile gloves protect both the wearer and the patient from the spread of disease, such as Covid-19. Nitrile gloves are also highly chemical and puncture resistant.

DISPOSABLE GLOVES - US Foods

Nitrile Gloves • Form-fitting, powder-free and latex-free; blue or black in color ... 7821309 Small Nitrile Powder-Free Blue 4/250 EA ... Nitrile Disposable Gloves A-Code Product Description Pack Size 3991924 Small Synthetic Powder-Free 10/100 EA

Nitrile Disposable Gloves - Disposable Latex Gloves ...

For everyday tasks that require single-use work gloves, Magid Glove & Safety provides disposable nitrile gloves/latex gloves for any work application. Disposable nitrile gloves/latex gloves are used in a variety of applications, including chemical processing, medical, paint manufacturing, metal treatment, inspection and quality control ...

Cranberry Evolve 300 Nitrile — Cranberry USA

The Evolve 300 Nitrile Powder Free Examination Gloves are Cranberry’s most popular and softest gloves yet, combining comfort and tensile strength without sacrificing tactile sensitivity. Cranberry’s exclusive EvoSoft formulation gives Evolve a unique silk-like attribute that is both soft and strong

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.

Cranberry Transcend Nitrile Exam Gloves — Cranberry USA

The Transcend Nitrile Powder Free Examination Gloves are Cranberry’s latest and strongest gloves yet, uncompromised superior formulation for high tensile strength without sacrificing tactile sensitivity that is both soft and strong with textured fingertips for precise gripping in dry and wet conditions.

Nitrile Glove - The World's Largest Manufacturer of Gloves

Nitrile Examination Glove is a disposable device intended for medical purposes that are worn on the examiner’s hand to prevent contamination between the patient and examiner. European Countries : Class I Directive MDD 93/42/EEC; United States of America (USA) : Class I with approved 21.CFR.820 FDA 510(K) More Details Download Brochure Send ...

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.

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.

3M™ Nitrile Gloves | 3M United States

Oct 22, 2020·3M™ Nitrile Gloves, used to help protect hands from most solvents, offers comfortable and reliable hand protection. 3M™ Nitrile Gloves are puncture resistant so solvents can stay on the gloves and not on hands.

Medium Thick Blue Nitrile Exam Gloves (100 Gloves/Box)

Safety Zone Blue Nitrile Gloves are great general use work gloves. They are form-fitting and durable, terrific for painting, pet care, auto care and a wide range of other uses. Safety Zone gloves are trusted across multiple industries nationwide.

DISPOSABLE GLOVES - US Foods

Nitrile Gloves • Form-fitting, powder-free and latex-free; blue or black in color ... 7821309 Small Nitrile Powder-Free Blue 4/250 EA ... Nitrile Disposable Gloves A-Code Product Description Pack Size 3991924 Small Synthetic Powder-Free 10/100 EA

Nitrile Glove - The World's Largest Manufacturer of Gloves

Nitrile Examination Glove is a disposable device intended for medical purposes that are worn on the examiner’s hand to prevent contamination between the patient and examiner. European Countries : Class I Directive MDD 93/42/EEC; United States of America (USA) : Class I with approved 21.CFR.820 FDA 510(K) More Details Download Brochure Send ...

Extra Long Disposable Gloves | Disposable Nitrile Gloves ...

The MICROFLEX® 93-244 nitrile examination gloves provide 33% longer, up-to-the-elbow personal protection in high risk situations. They have been tested against 10 commonly used chemicals in the Sterilization Department and against 9 cytostatics. MICROFLEX® 93-244 offers reliable protection in a broad range of applications in healthcare settings.

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.