nitrile gloves fda medical device pdf printable

510(K) Premarket Notification - Food and Drug Administration

Medical Devices Databases A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.

Product Specs — Cranberry USA

Product Specs. Product Specs & info. Nitrile Gloves I Chloroprene Gloves I Latex Gloves I Vinyl Gloves I Facemasks I Dental Dams. NITRILE GLOVES. Aqua Source. CR3440 Series. Download Spec Sheets (pdf) Carbon. CR3230 Series.

Kimberly-Clark Purple Nitrile Exam Gloves

KIMBERLY-CLARK* KC500 PURPLE NITRILE* Exam Gloves †D6319-00a Standard Specification for Nitrile Examnination Glove for Medical Applications ††Sterile PURPLE NITRILE-XTRA* = 305 mm†D6319-00a Standard Specification for Nitrile Examination Glove for Medical Applications TEST & TECHNICAL DATA Test Objective Relevance FDA Requirement (Eff. 12/08) ASTM D631 ...

:: Our Certificates : Producer of Latex Glove ,Natural ...

Certified PRP is registered and has listed Medical Device with U.S. Food and Drug Administration. Products Latex Patient Examination Glove Polymer Patient Examination Glove. Valid From 20 Febuary 2020. Preview D045943 PDF file. D080681 PDF file. E396728 PDF file.

Federal Register :: Medical Devices; Class I Surgeon's and ...

Apr 16, 2021·Based on the risks inherent with surgeon's gloves and patient examination gloves and the diseases being prevented, FDA's experience with these devices, and other relevant considerations, HHS and FDA believe that gloves with the product codes LYY, LYZ, OIG, OPC, OPH, LZC, and OPA are intended for uses which are of substantial importance in ...

THE WORLD OF DISPOSABLE GLOVES

Nitrile gloves are made of nitrile butadien rubber (NBR), which is a synthetic material, and can be used as an al-ternative for people allergic to natural latex or those who want to prevent an allergy. Another advantage is the en-hanced resistance to many chemicals*, particularly to oils. Which are the advantages and disadvantages

Amazon: nitrile food safe gloves

Salon World Safety Blue Nitrile Disposable Gloves, Box of 100, Size Medium, 3.5 Mil - Latex Free, Textured, Food Safe. 4.4 out of 5 stars. 128. $17.96.

NFPA 1999: A STANDARD OF PROTECTIVE CLOTHING FOR EMS ...

Mar 01, 1994·In addition to glove durability, NFPA 1999 addresses the sizing and usability of gloves. Manufacturers must provide emergency medical gloves in at least five sizes.

Kimberly-Clark Purple Nitrile Exam Gloves Datasheet

deserve the worry-free protection of Kimberly-Clark * Purple Nitrile Exam Gloves. Our gloves guard against incidental splash exposure. The gloves are made of a highly durable nitrile polymer that eliminates the risks and costs associated with type 1 natural rubber latex allergies.

Nitrile Examination Glove

Beaded cuff ensures easy donning and prevent roll down. Superior strength with better puncture resistance. Finger or palm textured enhanced wet and dry grip. Thinner gauge improves tactile sensitivity. Custom design enhanced comfort and fit. Provide an alternative solution for individuals who are allergic to Natural Rubber Latex.

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ...

The subject device is a patient examination glove made from a Nitrile compound, Blue in colour, powder free and non sterile (as per 21 CFR 880.6250, class I). The principle operation of the medical device to provide single use barrier protection for the wearer

Cranberry Transcend Nitrile Exam Gloves — Cranberry USA

Cranberry Transcend nitrile exam gloves feature patented low Derma technology that eliminates sulfur-based chemical accelerators commonly found in nitrile gloves, reducing the potential of Type I & Type IV allergic reactions. The first Fentanyl resistance glove granted by FDA to protect against

Guidance for Industry and FDA Staff

Guidance for Industry and FDA Staff . Medical Glove Guidance Manual . Document issued on January 22, 2008 . This document supersedes Guidance for Medical Gloves – A Workshop

THE WORLD OF DISPOSABLE GLOVES

Nitrile gloves are made of nitrile butadien rubber (NBR), which is a synthetic material, and can be used as an al-ternative for people allergic to natural latex or those who want to prevent an allergy. Another advantage is the en-hanced resistance to many chemicals*, particularly to oils. Which are the advantages and disadvantages