| ASTM D7103-06 (Reapproved 2013) Standard Guide for Assessment of Medical Gloves |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 6-176 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Section 10 "Assessment of Resistance to Viral Penetration" |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Katharine Segars FDA/OMPT/CDRH/ODE/DAGID/INCB 240-402-2780 Katharine.Segars@fda.hhs.gov |
Conflicts with an existing regulation. Section 10: Assessment of Resistance to Viral Penetration is in conflict with an existing regulation. See section 21 CFR 800.20 Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration. Subsection b)(1)(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.
1.1 This guide is intended to assist in the identification and application of the most appropriate ASTM and associated standards for the assessment, development of specifications, and selection of medical gloves with the ultimate goal of maintaining the safety and health of healthcare workers who may come into contact with biological and chemical hazards.
1.2 No guidance document or assessment protocol can ensure the selection of medical gloves that guarantees healthcare worker protection. The purpose of testing and assessing medical gloves is to generate the performance data and quality information that will allow the most appropriate assessment and selection of medical gloves. Ultimately, the selection of medical gloves shall be based on the evaluation of available technical data, quality information, and professional assessment of risk.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.6250 | Finger Cot | Class 1 | LZB |
| §880.6250 | Latex Patient Examination Glove | Class 1 | LYY |
| §880.6250 | Polymer Patient Examination Glove | Class 1 | LZA |
| §880.6250 | Vinyl Patient Examination Glove | Class 1 | LYZ |
| §878.4460 | Surgeon'S Gloves | Class 1 | KGO |
| 800.20 Patient examination gloves and surgeons gloves; sample plans and test method for leakage defects; a | |||
| Medical Glove Guidance Manual - Guidance for Industry and FDA Staff, Issued January 2008. |