Key documents
Following is a list of Web sites that provide additional information on latex. Information found on the Internet does not reflect the opinions or business relationships of Premier.
FDA (Food and Drug Administration)
A series of documents are available from the FDA by going to the listed Web site and following the sequence of listed links for each document.
FDA Guidance for Conducting Stability Testing to Support an Expiration Date Labeling Claim for Medical Gloves
This document contains guidance on the basic regulatory requirements set forth by the FDA that all manufacturers and importers must consider when they plan to market medical gloves. The document may be downloaded at the listed site. Go to: “CDRH,” “Topics,” “Gloves,” “Guidance for conducting stability testing.”
FDA Medical Glove Guidance Manual (Draft)
This document contains guidance on the basic regulatory requirements set forth by the FDA that all manufacturers and importers must consider when they plan to market medical gloves. The document may be downloaded at the listed site. Go to: “CDRH,” “Topics,” “Gloves,” “Draft medical glove guidance manual.”
FDA Medical Glove Powder Report, September 1997
This report evaluates whether the Center for Devices and Radiological Health’s position and policies adequately describe the potential adverse health effects of medical glove powder. The document may be downloaded at the listed site. Go to: “CDRH,” “Topics,” “Gloves,” “Medical glove powder report.”
FDA Federal Register Notice: Natural Rubber-Containing Medical Devices; User Labeling
This document contains guidance on the basic regulatory requirements set forth by the FDA that all manufacturers and importers must consider when they plan to market medical gloves. The document may be downloaded at the listed site. Go to: “CDRH,” “Topics,” “Labeling,” “FR Notice: Natural rubber containing medical devices.”
FDA Surgeon’s and Patient Examination Gloves; Reclassification and Medical Glove Guidance Manual Availability; Proposed Rule and Notice
Proposed regulation to reclassify all surgeon's and patient examination gloves as class II medical devices because the FDA believes that general controls are insufficient to provide a reasonable assurance of safety and effectiveness. The document may be downloaded at the listed site. Go to: “CDRH”, “Topics,” “Gloves,” “Surgeon’s and Patient Examination Gloves.”
NIOSH (National Institute for Occupational Safety and Health)
Preventing Allergic Reactions to Natural Rubber Latex in the Workplace, DHHS (NIOSH) Publication No. 97-135
NIOSH recommends the use of gloves for low-risk activities. If latex gloves are used, they should be powder-free with reduced protein content. They do not recommend the use of oil-based hand creams or lotions. They do recommend frequent cleaning of work areas contaminated with latex dust and the frequent changing of the ventilation filters and vacuum bags used in latex contaminated areas.
Copies are available from the NIOSH publications office. Call 1.800.356.4674. The full document may be downloaded at the listed site. Go to: “NIOSH,” “Latexalt.”
http://www.cdc.gov/niosh/latexalt.html
Latex Allergy: A Prevention Guide, DHHS (NIOSH) Publication No. 98-113.
Presents basic information on latex allergy and ways to prevent sensitization. Copies are available from the NIOSH publications office. Call 1.800.356.4674.
The full documents may be downloaded. Go to: “98-113.”
Latex Allergy: NIOSH Fact Sheet, June, 1997.
Describes latex allergy and those at risk of becoming sensitized. Also includes the NIOSH recommendations for reducing allergic reactions to latex in the workplace.
The full document may be downloaded.
http://www.cdc.gov/niosh/latexfs.html
OSHA (Occupational Safety and Health Agency)
Potential for Allergy to Natural Rubber Latex Gloves and other Natural Rubber Products, OSHA Technical Information Bulletin, April, 1999
This technical information bulletin is intended to alert field personnel to the potential for allergic reactions in some individuals using natural rubber latex (NRL) products, particularly gloves, in the workplace setting. It states that latex gloves should be for workers only in situations requiring protection from infectious agents, and the latex gloves should have low protein and be powder-free. Alternative non-latex gloves for workers with allergies should be provided.
The full document may be downloaded. Go to: “Subject index,” “Latex allergy,” “Potential for allergy to natural rubber latex gloves.”