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

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) Test method. For the purposes of this regulation, FDA's analysis of gloves for leaks will be conducted by a water leak method, using 1,000 milliliters (mL) of water. Each medical glove will be analyzed independently. When packaged as pairs, each glove is considered separately, and both gloves will be analyzed. A defect on one of the gloves is counted as one defect; a defect in both gloves is counted as two defects. Defects are defined as leaks, tears, mold, embedded foreigh objects, etc. 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. Leaks within 1 and 1/2 inches of the cuff are to be disregarded.

  (1) The following materials are required for testing: A 2 3/8-inch by 15-inch (clear) plastic cylinder with a hook on one end and a mark scored 1 1/2 inches 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); elastic strapping with velcro or other fastening material; automatic water-dispensing apparatus or manual device capable of delivering 1,000 mL of water; a stand with horizontal rod for hanging the hook end of the plastic tube. The 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 11 pounds.

  (2) The following methodology is used: Examine the sample and identify code/ lot number, size, and brand as appropriate. Examine gloves for defects as follows: carefully remove the glove from the wrapper, box, etc., visually examining each glove for defects. Visual defects in the top 1 1/2 inches of a glove will not be counted as a defect for the purposes of this rule. Visually defective gloves do not require further testing but are to be included in the total number of defective gloves counted for the sample. Attach the glove to the plastic fill tube by bringing the cuff end to the 1 1/2-inch mark and fastening with elastic strapping to make a watertight seal. Add 1,000 mL of room temperature water (i.e., 20 C to 30 C) into the open end of the fill tube. The water shall 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.) (3) Immediately after adding the water, examine the glove for water leaks. Do not squeeze the glove; use only minimal manipulation to spread the fingers to check for leaks. Water drops may be blotted to confirm leaking. 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). Make a second observation for leaks 2 minutes after addition of the water to the glove. Use only minimal manipulation of the fingers to check for leaks.

Record the number of defective gloves.

  (c) Sample plans. FDA will collect samples from lots of gloves to perform the test for defects described in paragraph (b) of this section in accordance with FDA's sampling inspection plans which are based on the tables of MIL-STD-105E (the military sampling standard, Sampling Procedures and Tables for Inspection by Attributes, May 10, 1989). Based on the acceptable quality levels found in this standard, FDA has defined adulteration as follows: 2.5 or higher for surgeons' gloves and 4.0 or higher for patient examination gloves at a general inspection level II.

FDA will use single normal sampling for lots of 1,200 gloves or less and multiple normal sampling for all larger lots. For convenience, the sample plans (sample size and accept/reject numbers) are shown in the following tables: Adulteration Level at 2.5 for Surgeons' Gloves ---------------------------------------------------------------------------------------------------------------- Number defective Lot size Sample Sample Number --------------------- size examined Accept Reject ---------------------------------------------------------------------------------------------------------------- 35,001 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 35,000 to 10,001........................ 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 10,000 to 3,201......................... 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 3,200 to 1,201.......................... 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 1,200 to 501............................ Single sample............. ......... 80 5 6 500 to 281.............................. Single sample............. ......... 50 3 4 280 to 151.............................. Single sample............. ......... 32 2 3 150 to 51............................... Single sample............. ......... 20 1 2 50 to 0................................. Single sample............. ......... 5 0 1 ---------------------------------------------------------------------------------------------------------------- Adulteration Level at 4.0 for Patient Examination Gloves ---------------------------------------------------------------------------------------------------------------- Number defective Lot size Sample Sample Number --------------------- size examined Accept Reject ---------------------------------------------------------------------------------------------------------------- 10,001 and above........................ First..................... 80 80 2 9 Second.................... 80 160 7 14 Third..................... 80 240 13 19 Fourth.................... 80 320 19 25 Fifth..................... 80 400 25 29 Sixth..................... 80 480 31 33 Seventh................... 80 560 37 38 10,000 to 3,201......................... First..................... 50 50 1 7 Second.................... 50 100 4 10 Third..................... 50 150 8 13 Fourth.................... 50 200 12 17 Fifth..................... 50 250 17 20 Sixth..................... 50 300 21 23 Seventh................... 50 350 25 26 3,200 to 1,201.......................... First..................... 32 32 0 5 Second.................... 32 64 3 8 Third..................... 32 96 6 10 Fourth.................... 32 128 8 13 Fifth..................... 32 160 11 15 Sixth..................... 32 192 14 17 Seventh................... 32 224 18 19 1,200 to 501............................ Single sample............. ......... 80 7 8 500 to 281.............................. Single sample............. ......... 50 5 6 280 to 151.............................. Single sample............. ......... 32 3 4 150 to 91............................... Single sample............. ......... 20 2 3 90 to 26................................ Single sample............. ......... 13 1 2 25 to 0................................. Single sample............. ......... 3 0 1 ---------------------------------------------------------------------------------------------------------------- (d) Lots of gloves which are tested and rejected using the test method according to paragraph (b) of this section, are adulterated within the meaning of section 501(c) of the Federal Food, Drug, and Cosmetic Act, and are subject to regulatory action, such as detention of imported products and seizure of domestic products.

[55 FR 51256, Dec. 12, 1990]