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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR800.20]
See Related Information on Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 800 -- GENERAL

Subpart B--Requirements for Specific Medical Devices

Sec. 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 SizeSampleSample SizeNumber ExaminedNumber Defective
AcceptReject
8 to 90Single sample 801
91 to 280Single sample 3212
281 to 500Single sample 5023
501 to 1,200Single sample 8034
1,201 to 3,200First3232--4
Second326415
Third329626
Fourth3212837
Fifth3216058
Sixth3219279
Seventh32224910
3,201 to 10,000First505004
Second5010016
Third5015038
Fourth50200510
Fifth50250711
Sixth503001012
Seventh503501314
10,001 to 35,000First808005
Second8016038
Third80240610
Fourth80320813
Fifth804001115
Sixth804801417
Seventh805601819
35,000First12512517
Second125250410
Third125375813
Fourth1255001217
Fifth1256251720
Sixth1257502123
Seventh1258752526

Accept/Reject Criteria at 2.5 AQL for Patient Examination Gloves

Lot SizeSampleSample SizeNumber ExaminedNumber Defective
AcceptReject
5 to 50Single sample 501
51 to 150Single sample 2012
151 to 280Single sample 3223
281 to 500Single sample 5034
501 to 1,200Single sample 8056
1,201 to 3,200First323204
Second326416
Third329638
Fourth32128510
Fifth32160711
Sixth321921012
Seventh322241314
3,201 to 10,000First505005
Second5010038
Third50150610
Fourth50200813
Fifth502501115
Sixth503001417
Seventh503501819
10,001 to 35,000First808017
Second80160410
Third80240813
Fourth803201217
Fifth804001720
Sixth804802123
Seventh805602526
35,000 and aboveFirst12512529
Second125250714
Third1253751319
Fourth1255001925
Fifth1256252529
Sixth1257503133
Seventh1258753738

(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 SizeSampleSample SizeNumber Defective
AcceptReject
13 to 90Single sample1301
91 to 500Single sample5012
501 to 1,200Single sample8023
1,201 to 3,200Single sample12534
3,201 to 10,000Single sample20056
10,001 to 35,000Single sample31589
35,000 and aboveSingle sample5001213

Accept/Reject Criteria at 2.5 AQL for Reconditioned Patient Examination Gloves

Lot SizeSampleSample SizeNumber Defective
AcceptReject
8 to 50Single sample801
51 to 280Single sample3212
281 to 500Single sample5023
501 to 1,200Single sample8034
1,201 to 3,200Single sample12556
3,201 to 10,000Single sample20089
10,001 to 35,000Single sample3151213
35,000 and aboveSingle sample5001819

[55 FR 51256, Dec. 12, 1990, as amended at 71 FR 75876, Dec. 19, 2006]

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