# K252622: Male Latex Condom HA

- Pathway: 510(k) (Abbreviated)
- Applicant: Okamoto USA, Inc.
- Decided: May 4, 2026 after 258 days
- Product code: HIS (Condom)
- 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
Longest line of descent: 3 generations back to K872812 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192669: Extremely Thin 003, ZERO ZERO THREE, Okamoto USA, Inc. (2020) Summary page 5.

## Indications for use
The Male Latex Condom HA is used for contraceptive and prophylactic purposes (preventing transmission of sexually transmitted infections).

Source page: https://510kreport.com/device/K252622
Methodology: https://510kreport.com/methodology