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BACKGROUND:
Surgeon's and patient examination gloves have been increasingly relied upon by health
care workers as a barrier to the transmission of Human Immunodeficiency Virus (HIV) and
other blood and fluid-borne infectious agents. On August 21, 1987, the Centers for Disease
Control recommended that health care workers wear medical gloves routinely because of the
potential for transmission of HIV between patients and health care workers. Because hard
to detect glove defects, such as holes, can compromise the effectiveness of the glove
barrier and pose risk to the health of both patients and health care workers, FDA issued
guidelines to the field districts on September 28, 1988, to sample and analyze surgeon's
and patient examination gloves of both domestic and foreign origin. Gloves were leak
tested using the 1000 mL water method. Regulatory actions under existing authority, such
as seizures and detentions of specific glove lots, were handled on a case by case basis.
Surgeon's glove lots with failure rates of 10% (10 units in 100) or higher, and patient
examination gloves with failure rates of 20% (20 units in 100) or higher were subject to
regulatory action. In view of the rapid increase in demand for imported and domestically
produced gloves, and the public health benefits of further reducing the risk of
transmission of HIV and other blood and fluid borne infectious agents, and to better
utilize Agency resources, on November 21, 1989, FDA published in the Federal Register
proposed rules to insure that manufacturers of gloves manufacture gloves that are not
adulterated. The final rule was published on December 12, 1990, at 55 FR 51254.
FDA will collect samples from lots of gloves to perform the test for defects by the
water leak method using 1000 mL water as described in paragraph (b) Test Method of the
final rule entitled "Patient examination gloves and surgeon's gloves; sample plans
and test method for leakage defects; adulteration." 55 FR 51256 - 51258; 21 CFR
800.20.
The sampling inspection plan used by the FDA has been derived from MIL-STD-105E (the military standard for "Sampling Procedures and Tables for Inspection by Attributes"), based on general inspection level II, normal inspection, and an acceptable quality level (AQL) of 2.5% for surgeon's gloves and 4.0% for patient examination gloves. Single sampling will be used for lots less than or equal to 1200 gloves, while multiple sampling will be used for larger lots. The FDA sampling inspection plan is described in Attachment A - "Sampling Inspection Plan."
POLICY:
Surgeon's gloves and patient examination gloves that contain holes are adulterated devices. Adulteration will be determined on a lot by lot basis for enforcement purposes. [See 21 CFR 800.20.] Surgeon's gloves whose leakage defect rate exceeds an AQL of 2.5% and patient examination gloves whose leakage defect rate exceeds an AQL of 4.0% will be deemed actionable as described in 21 CFR 800.20. (Attachment A).
REGULATORY ACTION GUIDANCE:
Lots of surgeon's and patient examination gloves that fail the criteria in Attachment A - "Sampling Inspection Plan" are subject to direct reference seizure. Districts should forward seizure recommendations to the Division of Compliance Management and Operations (HFC-210).
SPECIMEN CHARGES:
NOTE: Complaints for the seizure of devices should not include allegations of shipment
in interstate commerce because allegations of interstate commerce are not required to
support seizure of devices. [See Section 304(a)(2).]
For lots of surgeon's gloves which are found to be defective at an AQL greater than
2.5%, and for lots of patient examination gloves which are found to be defective at an AQL
greater than 4.0% charge:
"The article is deemed adulterated within the meaning of the Act, 21 U.S.C. 351(c) because the quality of the gloves falls below that which it purports or is represented to possess in that the defect rate of the gloves exceeds the permissible rate identified at 21 CFR 800.20."
The proposed letter to the U.S. Attorney should also include the following two paragraphs:
Examination gloves are intended for use by health professionals such as physicians and dentists during routine medical and dental examinations. Health professionals rely on examination gloves to prevent the transmission and spread of disease. This has become increasingly important in light of the current AIDS epidemic.
We request seizure because analysis of the gloves by the Food and Drug Administration
(FDA) shows that their quality falls below that which it purports and is represented to
possess because the defect rate of the gloves exceeds the permissible level as set forth
in 21 CFR 800.20 ___ out of ___ gloves tested were found to leak or contain holes. 21
U.S.C. 351(c).
SAMPLING INSPECTION PLAN:
Sample Collection and Examination:
Five single and four multiple sample examination plans are presented below for various
lot sizes. Examination may cease when a lot is determined to be violative.
ADULTERATION LEVEL AT 2.5
FOR SURGEONS' GLOVES
Single Sample Plan for Lot Size 0 to 50
#Exam Defected Gloves
Gloves Accept Reject
5 5 1
Single Sample Plan for Lot Size 51 to 150
#Exam Defected Gloves
Gloves Accept Reject
20 1 2
Single Sample Plan for Lot Size 151 to 280
#Exam Defected Gloves
Gloves Accept Reject
32 2 3
Single Sample Plan for Lot Size 281 to 500
#Exam Defected Gloves
Gloves Accept Reject
50 3 4
Single Sample Plan for Lot Size 501 to 1,200
#Exam Defected Gloves
Gloves Accept Reject
80 5 6
Single Sample Plan for Lot Size 1,201 to 3,200
#Exam Number of Defects
Gloves Cumulative Accept Reject
1st 32 32 0 4
2nd 32 64 1 6
3rd 32 96 3 8
4th 32 128 5 10
5th 32 160 7 11
6th 32 192 10 12
7th 32 224 13 14
Single Sample Plan for Lot Size 3,201 to 10,000
#Exam Number of Defects
Gloves Cumulative Accept Reject
1st 50 50 0 5
2nd 50 100 3 8
3rd 50 150 6 10
4th 50 200 8 13
5th 50 250 11 15
6th 50 300 14 17
7th 50 350 18 19
Single Sample Plan for Lot Size 10,001 to 35,000
#Exam Number of Defects
Gloves Cumulative Accept Reject
1st 80 80 1 7
2nd 80 160 4 10
3rd 80 240 8 13
4th 80 320 12 17
5th 80 400 17 20
6th 80 480 21 23
7th 80 560 25 26
Single Sample Plan for Lot Size 35,001 or Greater
#Exam Number of Defects
Gloves Cumulative Accept Reject
1st 125 125 2 9
2nd 125 250 7 14
3rd 125 375 13 19
4th 125 500 19 25
5th 125 625 25 29
6th 125 750 31 33
7th 125 875 37 38
Six single and three multiple sample examination plan are presented below for various
lot sizes. Examination may cease when a lot is determined to be violative.
ADULTERATION AT 4.0
FOR PATIENT EXAMINATION GLOVES
Single Sample Plan for Lot Size 0 to 25
#Exam Defected Gloves
Gloves Accept Reject
3 0 1
Single Sample Plan for Lot Size 26 to 90
#Exam Defected Gloves
Gloves Accept Reject
13 1 2
Single Sample Plan for Lot Size 91 to 150
#Exam Defected Gloves
Gloves Accept Reject
20 2 3
Single Sample Plan for Lot Size 151 to 280
#Exam Defected Gloves
Gloves Accept Reject
32 3 4
Single Sample Plan for Lot Size 281 to 500
#Exam Defected Gloves
Gloves Accept Reject
50 5 6
Single Sample Plan for Lot Size for 501 to 1,200
#Exam Defected Gloves
Gloves Accept Reject
80 7 8
Sample Plan for Lot Size 1,201 to 3,200
#Exam Number of Defects
Gloves Cumulative Accept Reject
1st 32 32 0 5
2nd 32 64 3 8
3rd 32 96 6 10
4th 32 128 8 13
5th 32 160 11 15
6th 32 192 14 17
7th 32 224 18 19
Sample Plan for Lot Size 3,201 to 10,000
#Exam Number of Defects
Gloves Cumulative Accept Reject
1st 50 50 1 7
2nd 50 100 4 10
3rd 50 150 8 13
4th 50 200 12 17
5th 50 250 17 20
6th 50 300 21 23
7th 50 350 25 26
Sample Plan for Lot Size 10,001 or Greater
#Exam Number of Defects
Gloves Cumulative Accept Reject
1st 80 80 2 9
2nd 80 160 7 14
3rd 80 240 13 19
4th 80 320 19 25
5th 80 400 25 29
6th 80 480 31 33
7th 80 560 37 38
Issued: 5/31/91