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NEWS & INFORMATION
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Source To Surgery - April 2000, Vol. 8 Issue 2
A Review of the FDA Medical
Glove Reclassification Proposal, July 1999
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Patricia A. Fleming, RN, BA, Vice President of Marketing, Ansell Healthcare Products Inc.
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In July 1999 the FDA released its Medical Glove Reclassification Proposal, which seeks to reclassify surgical and examination medical gloves from Class 1 to Class II medical devices. This reclassification proposal covers both Natural Rubber Latex (NRL) and synthetic gloves which would be regulated in four categories:
- powdered surgical gloves
- powder-free surgical gloves
- powdered exam gloves
- powder-free exam gloves.
The proposal suggests powder level limits be placed on powdered and powder-free NRL and synthetic gloves. In addition, FDA recommends imposing protein limits on NRL gloves, imposing expiration dating and new labeling caution statements for actual powder and protein levels in the gloves.
The reasoning behind this reclassification is that new, publicly available, valid scientific evidence demonstrates that medical gloves should not remain as Class I because of:
- barrier integrity concerns,
- degradation of quality during storage,
- contamination concerns,
- concerns about exposure to NRL allergens and the role of glove powders as a carrier of NRL allergens, and the inability of general controls of Class I to address these issues.
The proposal is intended to reduce the adverse health effects caused by NRL protein allergens and glove powders, and reduce the adverse reactions from effects in the barrier integrity and quality of medical gloves.
SPECIFICALLY
The proposal is based on FDA's concern that a number of studies suggest cornstarch on surgical gloves can reduce tissue resistance to infection, enhance development of infection, cause granulomas and adhesions, act as a carrier of NRL proteins, and serve as a source of occupational asthma. Further, powder may also contribute to development of irritant dermatitis and Type IV allergy.
It is generally accepted that airborne allergen is directly related to the frequency of use of powdered gloves and to the level of allergen and/or powder on the gloves used. Repeated exposure to NRL proteins is considered to increase the probability that an individual will become sensitized.
In addition to glove powder, the FDA Medical Glove Reclassification Proposal also covers total allergenic proteins in NRL gloves, barrier-integrity properties, and storage.
PROPOSAL SPECIFICS
- POWDER ISSUE
- Proposal recommends that manufacturers of powdered surgical and exam gloves limit the amount of powder to no more than 120 mg of powder per glove, regardless of the size of the glove.
- Proposal recommends that manufacturers of powder-free surgical and exam gloves limit the amount of total trace (residual) powder to no more than 2 mg particulate weight (based on ASTM test standard D 6124-97) per glove, regardless of the size of the glove.
- FDA is seeking comment on the possible impact of these powder limits on barrier properties and shelf life of NRL gloves. FDA is also considering a future requirement that all surgical and exam gloves be powder-free and that a restriction be placed on the sale (advertising), distribution and use of powdered medical gloves. They are seeking comment on this issue.
- FDA has estimated that in the absence of regulation, within four years 80 percent of the glove market would consist of powder-free gloves. The proposed regulation is expected to accelerate these trends to within two years of implementation.
- PROTEIN ISSUE
- FDA proposes to limit the amount of water-extractable protein on the gloves to no more than 1200 micrograms (ug) of protein per glove regardless of glove size (according to the Modified Lowry method). FDA will not alter their current rule that prohibits claims lower than 50 ug of protein per gram of NRL.
- SHELF LIFE/EXPIRATION DATE
FDA proposes that all medical gloves bear an expiry date, being the date of manufacture, on their primary, retail and shipping carton. This expiration date must be based on stability testing, showing that the medical glove will continue to meet the manufacturer's specifications over the expected life of the glove.
- LABELING REQUIREMENT
In order to provide guidance to users, manufacturers would be required to provide new caution statements, which would include both the FDA's recommended limit for glove powder and protein levels, as well as the actual glove powder and protein levels present in the manufacturers' gloves. This labeling would appear on the principal display panel of packaging, outside package, container or wrapper and immediate container or wrapper.
- 510(k) REQUIREMENTS
While manufacturers will not be required to provide new 510(k)s to demonstrate shelf life, records of test data must be retained for each distinct glove design. Further, FDA does not require new 510(k) submissions for label changes or reduction in glove powders or NRL proteins that are made to comply with any final regulation based on this proposal, provided no changes requiring a 510(k) are made to the device.
FDA REQUEST FOR ADDITIONAL
COMMENT ON THE FOLLOWING ITEMS:
The FDA published these proposals in July 1999 and is seeking comment from manufacturers and the medical industry with regard to the timeframe for implementation of proposed rule; specifically could the proposed changes be completed within one year as opposed to two years, without incurring glove shortages?
In addition they are seeking comment as to whether the proposed powder limit will impact the glove barrier properties and shelf life of NRL and glove donning techniques;
With regard to powdered gloves, FDA has requested input as to whether there is still a need for powdered gloves and if so, what are those needs?
Manufacturers have been requested to comment on FDA's proposed imposition of restrictions on advertising, sales, distribution and use of powdered medical gloves, its consideration of a future ban of powdered medical gloves and additional labeling requiring manufacturers to state the primary ingredients in glove powder in the product labeling.
FDA is also requesting comment from industry on the proposed recommended protein limit levels and whether the powder and allergen levels proposed in this rule be recommended limits or required limits.
FDA Medical Glove Reclassification Proposal Rev 1.
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