Device type
Condom
Product code HIS · Class II · 21 CFR 884.5300 · Obstetrics/Gynecology
Recent 510(k)s
Sep 21, 2026
K262108
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 Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MO
Shanghai Personage Hygiene Products Co., Ltd.
- HIS
- Class II
Recent recalls
No recalls in the archive for HIS.