Obstetrical and gynecological devices; designation of special controls for male condoms made of natural rubber latex.
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.
D017280:Condoms / Q000145:classification* / Q000266:history; D049673:History, 20th Century; D006801:Humans; D007840:Latex; D008297:Male; D011356:Product Labeling / Q000331:legislation & jurisprudence*; D012408:Rubber; D012749:Sexually Transmitted Diseases / Q000517:prevention & control; D014481:United States; D014486:United States Food and Drug Administration
D007840:Latex; D012408:Rubber