ASTM D5151-06 (Reapproved 2015)

Standard Organization:

ASTM D5151-06 (Reapproved 2015)
Standard Test Method for Detection of Holes in Medical Gloves

Recognition Date	2016-06-27
Recognition List	043
Recognition Number	6-175
Extent	Complete standard
Standards Orgs	ASTM ASTM International http://www.astm.org/
STG	General Plastic Surgery/General Hospital
FDA Tech	John Stansberry FDA/OMPT/CDRH/ODE/DAGID/INCB 240-402-8915 John.Stansberry@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

1.1 This test method covers the detection of holes in medical gloves.

1.2 This test method is limited to the detection of holes that allow water leakage under the conditions of the test.

1.3 The smallest hole that will allow water leakage in a medical glove has not been determined and is beyond the scope of this test method.

1.4 The safe and proper use of medical gloves is beyond the scope of this test method.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§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

FDA Guidance:

Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex - Guidance for Industry and Food and Drug Administration Staff, Issued December 2, 2014.