ASTM D6499-16

Standard Organization:

ASTM D6499-16
Standard Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its Products

Recognition Date2016-12-23
Recognition List046
Recognition Number6-383
Extent Complete standard
Standards Orgs ASTM ASTM International http://www.astm.org/
STG General Plastic Surgery/General Hospital
FDA Tech  Anne D. Lucas   FDA/OMPT/CDRH/OSEL/DBCMS/   301-796-0283   anne.lucas@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 an immunological method to determine the amount of antigenic protein in Hevea Natural Rubber and its products using rabbit antisera specific for HNRL proteins. This immunoassay procedure quantitatively measures the level of antigenic latex proteins in solution using an inhibition format. The samples may include glove or other product extracts which have been collected in order to measure the HNR levels. Although this method detects antigenic proteins, it should not be considered as a measure of allergenic proteins. Correlation of protein/antigen levels with the level of allergenic proteins has not been fully established.

1.2 For the purpose of this test method, the range of protein will be measured in terms of microgram to milligram quantities.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§884.5300 Condom Class 2 HIS
§880.6250 Finger Cot Class 1 LZB
§880.6250 Latex Patient Examination Glove Class 1 LYY
§880.6250 Patient Examination Glove, Specialty Class 1 LZC
§878.4460 Surgeon'S Gloves Class 1 KGO

FDA Guidance:

Medical Glove Guidance Manual - Guidance for Industry and FDA Staff, Issued January 2008.

Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions - Guidance for Industry, Issued July 1998.

Compliance Policy Guide and FDA Test Methods (Sub Chapter 345 Obstetrics and Gynecology (Sec. 345.100 (CPG 7124.21)).


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