510(k) K262108 · HIS Condom
FAMA Male Latex Condoms Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms Aqueous Lubricant (Plain);FAMA Male Latex Condoms Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms Aqueous Lubricant (Dotted);FAMA Male Latex Condoms Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condom
| Applicant | Shanghai Personage Hygiene Products Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Sep 21, 2026 |
| Received | Jun 23, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262108
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.