Specification for Rubber Examination Gloves

ASTM Committee D­11 on Rubber has been the center for this important standard­setting activity since the mid­1970s. Faced with the challenges of determining pinhole leaks in rubber surgeons’ and examination gloves, this committee needed to develop better test methods than D 3577: Specifications for Rubber Surgical Gloves and D 3578: Specification for Rubber Examination Gloves to address health­care concerns about acquired immune deficiency syndrome (AIDS) and human immunodeficiency virus (HIV).

After considerable review, the committee published Standard Method D 5151: Test Method for Detection of Holes in Medical Gloves in 1990. This method resulted in an improved, more sensitive test to detect holes in medical gloves. While pinhole leaks were the primary concern in Committee D­11, Committee F­23 was focusing on penetration test methods for determining leaks with a synthetic blood test and a viral penetration test method using a bacteriophage surrogate to the AIDS and HIV viruses TPE gloves, Phi­X174.

These pass/fail test methods were evaluated in interlaboratory round­robin tests and were Emergency Standards ES 21: Test Method for Resistance of Protective Clothing Materials to Synthetic Blood and ES 22: Test Method for Resistance of Protective Clothing Materials to Penetration by Blood­Borne Pathogens Using Viral Penetration as a Test System Food gloves.3 These two test methods were used to evaluate performance of clothing and glove materials, but improved methods specifically for whole gloves were being investigated and considered by Committee F­23, as well. Both of these test methods are no longer emergency standards and now have been approved as consensus standards by the Biological Hazards Subcommittee F23.40 of F­23 and redesignated F 1670: Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood and F 1671: Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood­Borne Pathogens Using Phi­X174 Bacteriophage Penetration as a Test System, since the publication of the first edition of this book.

They have been utilized and cited in performance data for a number of gloves used in the health­care profession in the United States. Another test method that was also approved as a consensus standard was F 1819: Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood Using Mechanical Pressure Technique. This method supplements the previously adopted hydrostatic pressure head techniques and offers the capability of measuring penetration resistance at the greater mechanical pressures that might be encountered in osteoplastic surgery.

A new glove standard was also developed by ANSI and the Industrial Safety Equipment Association (ISEA) in early 2000.4 This standard, ANSI/ISEA 105–2000, Standard for Hand Protection Selection Criteria, provided several different properties for classifying the performance of gloves, including chemical­resistant gloves. The results for a specific glove style are reported according to the level achieved for the respective property Disposable Aprons. Performance properties are defined terms of four to six levels. Gloves not achieving the lowest level are reported as level 0.

Properties covered in the standard include:

• Cut resistance (ASTM F 1790)

• Puncture resistance (EN 388, Clause 6.4)

• Chemical permeation resistance (ASTM F 739)

• Chemical degradation resistance (new method)

• Liquid­tight integrity (ASTM D 5151)

• Flame resistance (ASTM F 1358)

• Heat degradation resistance (ISO 17493)

• Conductive heat resistance (ASTM F 1060)

• Conductive cold resistance (ISO 5085–1)