510(k) clearance
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
- 510(k) number
- K262108
- Applicant
- Shanghai Personage Hygiene Products Co., Ltd.
- Decision date
- Sep 21, 2026
- Date received
- Jun 23, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HIS
- Device type
- Condom
- Device class
- Class II
- Regulation
- 21 CFR 884.5300
- Advisory committee
- Obstetrics/Gynecology
- Statement or summary
- Summary
- Third party
- N
- Location
- Shanghai, CN