| ASTM D6499-16 Standard Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its Products |
| Recognition Date | 2016-12-23 |
| Recognition List | 046 |
| Recognition Number | 6-383 |
| 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 |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| 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 |
| 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)). |