fda nitrile medical glove specs

  • Home
  • /
  • fda nitrile medical glove specs

fda nitrile medical glove specs

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.

AIM-X Proposal for MEDICAL NITRILE GLOVES AIM X GDIH- fda nitrile medical glove specs ,1. Specifications sheet Specifications: 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 .09mm Palm .11mm Finger .13 mmKimberly-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.



Nitrile Gloves - Disposable Gloves - Medical Gloves

Latex - These gloves provide excellent dexterity and some puncture resistance. They are standbys in the medical industry and food handling occupations. Vinyl - An economical alternative to latex and nitrile, these gloves are a go-to in food processing and food handling activities. Polyethylene - These FDA-approved gloves for food contact are ...

Skymed Nitrile Gloves - MED GEAR USA

May 05, 2020·BC Gloves Nitrile Gloves BC Gloves Specification Certificate - FDA, CE, EN455 Size X-Small, Small, Medium, Large, X-Large Thickness Palm / Finger - Min 0.05mm Color Blue Carton Size & Weight 24 X 36 X 24 CM 5.5...

Simply Superieur Nitrile Gloves (Powder-Free ... - Supply FDA

Simply Supeieur Nitrile Examination Gloves. Comfortable, powder-free nitrile examination gloves, designed for both medical and food use. The gloves are ambidextrous and tested for use with chemotherapy drugs. Manufactured in Vietnam by Ever Global (Vietnam) Corporation, the sole distributer of the Simply Superieur brand.

Blue Nitrile Gloves Medical Grade Disposable Gloves ...

Jul 02, 2020·sizes for all types of customers. Blue nitrile gloves are made of rubber and come in various specifications with most being 4mm in thickness. We can do 5mm and 6mm thickness sizes for orders of 20 million units or more. Our blue nitrile gloves come with FDA and CDC certifications. Gloves are normally sold in a box of 100 units or 50 pair.

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.

Nitrile Exam Gloves | Chemo-rated Nitrile Exam Gloves ...

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. 9250/9252 Series Nitrile Powder-Free, Fingertip-Textured Exam Gloves

ASTM D6319 - 19 Standard Specification for Nitrile ...

This specification contains test procedures for evaluating the performance and safety of nitrile rubber gloves for use in conducting medical examinations and diagnostic and therapeutic procedures. The products covered by this specification include nitrile rubber gloves that fit either hand, paired gloves, and gloves by size and packaged sterile ...

ASTM D6319 - 19 Standard Specification for Nitrile ...

This specification contains test procedures for evaluating the performance and safety of nitrile rubber gloves for use in conducting medical examinations and diagnostic and therapeutic procedures. The products covered by this specification include nitrile rubber gloves that fit either hand, paired gloves, and gloves by size and packaged sterile ...

Skymed Nitrile Gloves - MED GEAR USA

May 05, 2020·BC Gloves Nitrile Gloves BC Gloves Specification Certificate - FDA, CE, EN455 Size X-Small, Small, Medium, Large, X-Large Thickness Palm / Finger - Min 0.05mm Color Blue Carton Size & Weight 24 X 36 X 24 CM 5.5...

Product Classification - Food and Drug Administration

Jan 18, 2021·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 …

FDA Registration of Latex and Nitrile gloves - fdahelp.us

16 行·FDA regulate latex and nitrile gloves (examination and surgical) as medical devices. Even …

Do Your Gloves Comply with FDA Recommendations and ...

Jun 01, 2017·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.”

ASTM D6319 - 19 Standard Specification for Nitrile ...

This specification contains test procedures for evaluating the performance and safety of nitrile rubber gloves for use in conducting medical examinations and diagnostic and therapeutic procedures. The products covered by this specification include nitrile rubber gloves that fit either hand, paired gloves, and gloves by size and packaged sterile ...

Simply Superieur Nitrile Gloves (Powder-Free ... - Supply FDA

Simply Supeieur Nitrile Examination Gloves. Comfortable, powder-free nitrile examination gloves, designed for both medical and food use. The gloves are ambidextrous and tested for use with chemotherapy drugs. Manufactured in Vietnam by Ever Global (Vietnam) Corporation, the sole distributer of the Simply Superieur brand.

Blue Nitrile Gloves - Powder-Free Medical Exam Gloves ...

Blue/Purple Nitrile Gloves - Powder-Free FDA Medical Grade Patient Examination Gloves per Regulation Number 21 CFR 880.6250. These Medical Blue Nitrile Gloves are constructed from lightweight nitrile with fully textured grip, measuring either 9 or 12 inches from fingertip to glove cuff.

High Use Exam Gloves Portfolio | Cardinal Health

FLEXAL™ Comfort is the next generation of our FLEXAL™ nitrile exam gloves. It combines an excellent fit with improved protection from chemotherapy drugs and lab chemicals. Also comes with an FDA approved low dermatitis potential claim.

PRODUCT SPECIFICATION Nitrile Powderfree Examination ...

May 31, 2011·TG Medical USA PRODUCT SPECIFICATION Nitrile Powderfree Examination Gloves (Textured) SECTION I: PRODUCT DESCRIPTION 1. 1 Type Nitrile Examination Glove, Powderfree, Non-sterile 1. 2 Material 100% Synthetic Nitrile Latex 1. 3 Color ( Pigment ) o Off white o Blue o Black 1. 4 Design and Feature Ambidextrous, textured, beaded cuff

US FDA Medical Device Labeling Requirements - Gloves

US FDA Medical Device Labeling Requirements - Gloves US FDA define label as "display of written, printed, or graphic matter upon the immediate container of any article". There are specific labeling requirements for examination and surgical gloves (nitrile and latex).

Standard Specification for Nitrile Examination Gloves for ...

This specification contains test procedures for evaluating the performance and safety of nitrile rubber gloves for use in conducting medical examinations and diagnostic and therapeutic procedures. The products covered by this specification include nitrile rubber gloves that fit either hand, paired gloves, and gloves by size and packaged sterile ...

PRODUCT SPECIFICATION Nitrile Powderfree Examination ...

May 31, 2011·TG Medical USA PRODUCT SPECIFICATION Nitrile Powderfree Examination Gloves (Textured) SECTION I: PRODUCT DESCRIPTION 1. 1 Type Nitrile Examination Glove, Powderfree, Non-sterile 1. 2 Material 100% Synthetic Nitrile Latex 1. 3 Color ( Pigment ) o Off white o Blue o Black 1. 4 Design and Feature Ambidextrous, textured, beaded cuff

510K Summary - Food and Drug Administration

Powdered Nitrile Examination Gloves as described in this 510OK Notification is substantially equivalent to the Class 1 patient examination glove bearing the product code 8OLZA (21CFR 880.6250). It meets the current specifications listed under the ASTM Specification D6319-O0a, Standard for Nitrile Gloves for Medical Application.

Nitrile Industrial Grade VS Nitrile Medical Grade Gloves

About Nitrile Medical Grade Gloves . Disposable gloves used during medical examinations in the medical field must have FDA approval. Meeting the safety requirements of the FDA means that the gloves are safe to use in the healthcare field. Their strength can withhold against and protect an individual against blood borne pathogens.

FLEXAL™ Nitrile Medical Gloves | Cardinal Health

Footnotes and references: *GHX/ HPIS D_MAT2015 1 Caution: Gloves used for protection against chemotherapy drug and laboratory chemical exposure should be selected specifically for the type of chemicals being used. 2 This Cardinal Health product helps healthcare facilities comply with the USP <800> standard for the safe handling of hazardous drugs.. Note: Review Safety Data Sheets (SDS) …

510K Summary - Food and Drug Administration

Powdered Nitrile Examination Gloves as described in this 510OK Notification is substantially equivalent to the Class 1 patient examination glove bearing the product code 8OLZA (21CFR 880.6250). It meets the current specifications listed under the ASTM Specification D6319-O0a, Standard for Nitrile Gloves for Medical Application.