ClearanceBrief
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

ApplicantShanghai Personage Hygiene Products Co., Ltd., Shanghai, CN
DecisionSubstantially Equivalent, Sep 21, 2026
ReceivedJun 23, 2026
TypeTraditional
FDA recordOpen 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.