21 CFR 800.20 - Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration.

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§ 800.20 Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration.
(a) Purpose. The prevalence of human immunodeficiency virus (HIV), which causes acquired immune deficiency syndrome (AIDS), and its risk of transmission in the health care context, have caused the Food and Drug Administration (FDA) to look more closely at the quality control of barrier devices, such as surgeons' gloves and patient examination gloves (collectively known as medical gloves) to reduce the risk of transmission of HIV and other blood-borne infectious diseases. The Centers for Disease Control (CDC) recommend that health care workers wear medical gloves to reduce the risk of transmission of HIV and other blood-borne infectious deseases. The CDC recommends that health care workers wear medical gloves when touching blood or other body fluids, mucous membranes, or nonintact skin of all patients; when handling items or surfaces soiled with blood or other body fluids; and when performing venipuncture and other vascular access procedures. Among other things, CDC's recommendation that health care providers wear medical gloves demonstrates the proposition that devices labeled as medical gloves purport to be and are represented to be effective barriers against the transmission of blood- and fluid-borne pathogens. Therefore, FDA, through this regulation, is defining adulteration for patient examination and surgeons' gloves as a means of assuring safe and effective devices.
(1) For a description of a patient examination glove, see § 880.6250. Finger cots, however, are excluded from the test method and sample plans in paragraphs (b) and (c) of this section.
(2) For a description of a surgeons' glove, see § 878.4460 of this chapter.
(b)
(1) General test method. For the purposes of this part, FDA's analysis of gloves for leaks and visual defects will be conducted by a visual examination and by a water leak test method, using 1,000 milliliters (ml) of water.
(i) Units examined. Each medical glove will be analyzed independently. When packaged as pairs, each glove is considered separately, and both gloves will be analyzed.
(ii) Identification of defects. For this test, defects include leaks detected when tested in accordance with paragraph (b)(3) of this section. A leak is defined as the appearance of water on the outside of the glove. This emergence of water from the glove constitutes a watertight barrier failure. Other defects include tears, embedded foreign objects, extrusions of glove material on the exterior or interior surface of the glove, gloves that are fused together so that individual glove separation is impossible, gloves that adhere to each other and tear when separated, or other visual defects that are likely to affect the barrier integrity.
(iii) Factors for counting defects. One defect in one glove is counted as one defect. A defect in both gloves in a pair of gloves is counted as two defects. If multiple defects, as defined in paragraph (b)(1)(ii) of this section, are found in one glove, they are counted as one defect. Visual defects and leaks that are observed in the top 40 millimeters (mm) of a glove will not be counted as a defect for the purposes of this part.
(2) Leak test materials. FDA considers the following to be the minimum materials required for this test :
(i) A 60 mm by 380 mm (clear) plastic cylinder with a hook on one end and a mark scored 40 mm from the other end (a cylinder of another size may be used if it accommodates both cuff diameter and any water above the glove capacity);
(ii) Elastic strapping with velcro or other fastening material;
(iii) Automatic water-dispensing apparatus or manual device capable of delivering 1,000 ml of water;
(iv) Stand with horizontal rod for hanging the hook end of the plastic tube. The horizontal support rod must be capable of holding the weight of the total number of gloves that will be suspended at any one time, e.g., five gloves suspended will weigh about 5 kilograms (kg);
(v) Timer capable of measuring two minute intervals.
(3) Visual defects and leak test procedures. Examine the sample and identify code/lot number, size, and brand as appropriate. Continue the visual examination using the following procedures:
(i) Visual defects examination. Inspect the gloves for visual defects by carefully removing the glove from the wrapper, box, or package. Visually examine each glove for defects. As noted in paragraph (b)(1)(iii) of this section, a visual defect observed in the top 40 mm of a glove will not be counted as a defect for the purpose of this part. Visually defective gloves do not require further testing, although they must be included in the total number of defective gloves counted for the sample.
(ii) Leak test set-up.
(A) During this procedure, ensure that the exterior of the glove remains dry. Attach the glove to the plastic fill tube by bringing the cuff end to the 40 mm mark and fastening with elastic strapping to make a watertight seal.
(B) Add 1,000 ml of room temperature water (i.e., 20 (deg)C to 30 (deg)C) into the open end of the fill tube. The water should pass freely into the glove. (With some larger sizes of long-cuffed surgeons' gloves, the water level may reach only the base of the thumb. With some smaller gloves, the water level may extend several inches up the fill tube.)
(iii) Leak test examination. Immediately after adding the water, examine the glove for water leaks. Do not squeeze the glove; use only minimum manipulation to spread the fingers to check for leaks. Water drops may be blotted to confirm leaking.
(A) If the glove does not leak immediately, keep the glove/filling tube assembly upright and hang the assembly vertically from the horizontal rod, using the wire hook on the open end of the fill tube (do not support the filled glove while transferring).
(B) Make a second observation for leaks 2 minutes after the water is added to the glove. Use only minimum manipulation of the fingers to check for leaks.
(C) Record the number of defective gloves.
(c) Sampling, inspection, acceptance, and adulteration. In performing the test for leaks and other visual defects described in paragraph (b) of this section, FDA will collect and inspect samples of medical gloves, and determine when the gloves are acceptable as set out in paragraphs (c)(1) through (c)(3) of this section.
(1) 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.”
(2) 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.
(3) Adulteration levels and accept/reject criteria. FDA considers a lot of medical gloves to be adulterated when the number of defective gloves found in the tested sample meets or exceeds the applicable rejection number at the 1.5 AQL for surgeons' gloves or the 2.5 AQL for patient examination gloves. These acceptance and rejection numbers are identified in the tables following paragraph (c)(3) of this section as follows:
Accept/Reject Criteria at 1.5 AQL for Surgeons' Gloves
Lot Size Sample Sample Size Number Examined Number Defective
Accept Reject
8 to 90 Single sample 8 0 1
91 to 280 Single sample 32 1 2
281 to 500 Single sample 50 2 3
501 to 1,200 Single sample 80 3 4
1,201 to 3,200 First 32 32 4
Second 32 64 1 5
Third 32 96 2 6
Fourth 32 128 3 7
Fifth 32 160 5 8
Sixth 32 192 7 9
Seventh 32 224 9 10
3,201 to 10,000 First 50 50 0 4
Second 50 100 1 6
Third 50 150 3 8
Fourth 50 200 5 10
Fifth 50 250 7 11
Sixth 50 300 10 12
Seventh 50 350 13 14
10,001 to 35,000 First 80 80 0 5
Second 80 160 3 8
Third 80 240 6 10
Fourth 80 320 8 13
Fifth 80 400 11 15
Sixth 80 480 14 17
Seventh 80 560 18 19
35,000 First 125 125 1 7
Second 125 250 4 10
Third 125 375 8 13
Fourth 125 500 12 17
Fifth 125 625 17 20
Sixth 125 750 21 23
Seventh 125 875 25 26
Accept/Reject Criteria at 2.5 AQL for Patient Examination Gloves
Lot Size Sample Sample Size Number Examined Number Defective
Accept Reject
5 to 50 Single sample 5 0 1
51 to 150 Single sample 20 1 2
151 to 280 Single sample 32 2 3
281 to 500 Single sample 50 3 4
501 to 1,200 Single sample 80 5 6
1,201 to 3,200 First 32 32 0 4
Second 32 64 1 6
Third 32 96 3 8
Fourth 32 128 5 10
Fifth 32 160 7 11
Sixth 32 192 10 12
Seventh 32 224 13 14
3,201 to 10,000 First 50 50 0 5
Second 50 100 3 8
Third 50 150 6 10
Fourth 50 200 8 13
Fifth 50 250 11 15
Sixth 50 300 14 17
Seventh 50 350 18 19
10,001 to 35,000 First 80 80 1 7
Second 80 160 4 10
Third 80 240 8 13
Fourth 80 320 12 17
Fifth 80 400 17 20
Sixth 80 480 21 23
Seventh 80 560 25 26
35,000 and above First 125 125 2 9
Second 125 250 7 14
Third 125 375 13 19
Fourth 125 500 19 25
Fifth 125 625 25 29
Sixth 125 750 31 33
Seventh 125 875 37 38
(d) Compliance. Lots of gloves that are sampled, tested, and rejected using procedures in paragraphs (b) and (c) of this section, are considered adulterated within the meaning of section 501(c) of the act.
(1) Detention and seizure. Lots of gloves that are adulterated under section 501(c) of the act are subject to administrative and judicial action, such as detention of imported products and seizure of domestic products.
(2) Reconditioning. FDA may authorize the owner of the product, or the owner's representative, to attempt to recondition, i.e., bring into compliance with the act, a lot or part of a lot of foreign gloves detained at importation, or a lot or part of a lot of seized domestic gloves.
(i) Modified sampling, inspection, and acceptance. If FDA authorizes reconditioning of a lot or portion of a lot of adulterated gloves, testing to confirm that the reconditioned gloves meet AQLs must be performed by an independent testing facility. The following tightened sampling plan must be followed, as described in ISO 2859 “Sampling Procedures for Inspection by Attributes:”
(A) General inspection level II,
(B) Single sampling plans for tightened inspection,
(C) 1.5 AQL for surgeons' gloves, and
(D) 2.5 AQL for patient examination gloves.
(ii) Adulteration levels and acceptance criteria for reconditioned gloves.
(A) FDA considers a lot or part of a lot of adulterated gloves, that is reconditioned in accordance with paragraph (d)(2)(i) of this section, to be acceptable when the number of defective gloves found in the tested sample does not exceed the acceptance number in the appropriate tables in paragraph (d)(2)(ii)(B) of this section for reconditioned surgeons' gloves or patient examination gloves.
(B) FDA considers a reconditioned lot of medical gloves to be adulterated within the meaning of section 501(c) of the act when the number of defective gloves found in the tested sample meets or exceeds the applicable rejection number in the tables following paragraph (d)(2)(ii)(B) of this section:
Accept/Reject Criteria at 1.5 AQL for Reconditioned Surgeons' Gloves
Lot Size Sample Sample Size Number Defective
Accept Reject
13 to 90 Single sample 13 0 1
91 to 500 Single sample 50 1 2
501 to 1,200 Single sample 80 2 3
1,201 to 3,200 Single sample 125 3 4
3,201 to 10,000 Single sample 200 5 6
10,001 to 35,000 Single sample 315 8 9
35,000 and above Single sample 500 12 13
Accept/Reject Criteria at 2.5 AQL for Reconditioned Patient Examination Gloves
Lot Size Sample Sample Size Number Defective
Accept Reject
8 to 50 Single sample 8 0 1
51 to 280 Single sample 32 1 2
281 to 500 Single sample 50 2 3
501 to 1,200 Single sample 80 3 4
1,201 to 3,200 Single sample 125 5 6
3,201 to 10,000 Single sample 200 8 9
10,001 to 35,000 Single sample 315 12 13
35,000 and above Single sample 500 18 19
[55 FR 51256, Dec. 12, 1990, as amended at 71 FR 75876, Dec. 19, 2006]

Title 21 published on 2014-04-01

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