# K971590: Tactylon Condom

- Pathway: 510(k) (Traditional)
- Applicant: Sensicon Corp.
- Decided: Oct 7, 1997 after 159 days
- Product code: MOL (Condom, Synthetic)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Natural Rubber Latex condom: named in the summary without a submission number

## Indications for use
For Latex Sensitive Condom Users: This is a TACTYLON® condom. This is not a latex condom. You may use this TACTYLON ® condom if you or your partner are allergic to latex. You should know: e The risks of pregnancy and sexually transmitted diseases (STDs), including AIDS (HIV infection), are not known for this condom. A study is being done. ¢ There are laboratory tests on this TACTYLON® material. These tests show that organisms even as small as sperm and viruses like HIV cannot pass through it. Latex condoms for men, if used correctly with every act of vaginal intercourse are highly effective at preventing pregnancy, as well as STDs, including AIDS (HIV infection).

Source page: https://510kreport.com/device/K971590
Methodology: https://510kreport.com/methodology