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Update Apr 03, 03
Medical Devices; Patient Examination and Surgeons' Gloves;
Test
Procedures and Acceptance Criteria
[Docket No. 03N-0056]
The Food and Drug Administration (FDA) is proposing to amend the
sampling plans, test method, and acceptable quality levels (AQLs) for
medical gloves contained in its medical device regulations. As prescribed
by its regulation, FDA samples patient examination and surgeons' gloves
and examines them for visual defects and water leaks. Glove lots are
considered adulterated if they do not meet the specified quality levels.
The objective of the proposed regulation is to improve the barrier quality
of medical gloves on the U.S. market. The updated regulation would
accomplish this by reducing the acceptable level of defects observed
during FDA testing of medical gloves. By reducing the AQLs for medical
gloves, FDA would also harmonize the level with consensus standards
developed by the International Organization for Standardization (ISO) and
the American Society for Testing Materials (ASTM).
The new FDA sampling will be done as follows:
- Sample plans. FDA will collect samples from lots of medical gloves
in accordance with agency sampling plans. These plans are based on
sample sizes, levels of sample inspection, and acceptable quality levels
(AQLs) found in the International Standard Organization's standard, ISO
2859, Sampling Procedures For Inspection By Attributes.
- Sample sizes, inspection levels, and minimum AQLs. FDA will use
single normal sampling for lots of 1,200 gloves or less and multiple
normal sampling for all larger lots. FDA will use general inspection
level II in determining the sample size for any lot size. As shown in
the tables following paragraph (c)(3) of this section, FDA considers a
1.5 AQL to be the minimum level of quality acceptable for surgeons'
gloves and a 2.5 AQL to be the minimum level of quality acceptable for
patient examination gloves.
All glove manufacturers should be aware of this sampling guideline to
assure that they do not fall below these levels and thus their shipment
will be rejected as adulterated.
For the sampling size and reject level see the chart at the following
link:
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-7601.html
Or contact mdi at info@mdiconsultants.com
.S. AGENT
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