Document Detail


Obstetrical and gynecological devices; designation of special controls for male condoms made of natural rubber latex.
MedLine Citation:
PMID:  19112703     Owner:  HSR     Status:  MEDLINE    
Abstract/OtherAbstract:
The Food and Drug Administration (FDA) is amending the classification regulation for condoms to designate a special control for male condoms made of natural rubber latex (latex). The special control for the device is the guidance document entitled "Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300." The FDA will publish a notice in the Federal Register announcing the availability of the special control guidance document no later than the effective date of this final rule.
Authors:
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Publication Detail:
Type:  Historical Article; Journal Article    
Journal Detail:
Title:  Federal register     Volume:  73     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2008 Nov 
Date Detail:
Created Date:  2008-12-29     Completed Date:  2009-01-02     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  66522-39     Citation Subset:  T    
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MeSH Terms
Descriptor/Qualifier:
Condoms / classification*,  history
History, 20th Century
Humans
Latex*
Male
Product Labeling / legislation & jurisprudence*
Rubber*
Sexually Transmitted Diseases / prevention & control
United States
United States Food and Drug Administration
Chemical
Reg. No./Substance:
0/Latex; 9006-04-6/Rubber

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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