Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Medical Glove Accelerated Aging Tests Acceptable For Expiration Dating

This article was originally published in The Gray Sheet

Executive Summary

Accelerated aging tests in support of medical glove expiration dating are acceptable for a two-year period, FDA says in a draft guidance released Nov. 16.

You may also be interested in...



Kimberly-Clark Enters $3 Bil. Glove Market Via $850 Mil. Safeskin Buy

Acquisition of disposable medical glove maker Safeskin marks Kimberly-Clark's entrance into the $3 bil. worldwide latex and synthetic glove market and will boost sales of the firm's professional health care segment to approximately $950 mil. in 2000.

Surgeon and patient examination gloves

Comment period for proposed rule published July 30 (1"The Gray Sheet" Aug. 2, p. 9) is extended to Jan. 27, 2000, due to requests from the American Society of Testing and Materials (ASTM) and Ansell Perry. The extension allows ASTM to complete pending revisions of four examination glove standards. In Oct. 14 comments to FDA, ASTM argues that the proposed limit of 1200 ug protein/glove is "impractical and confusing for both the manufacturer and consumer" because it is inconsistent with ASTM standards, which set the limit in units of protein/surface area

Medical Glove Proposed Rule Requires Labeling Statement, Expiration Dating

Medical gloves containing natural rubber latex (NRL) and/or powder would be required to bear in labeling cautionary statements indicating the actual level of glove powder, according to a proposed rule published by FDA in the July 30 Federal Register.

UsernamePublicRestriction

Register

OM007016

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel