FAMA Male Latex Condoms Aqueous Lubricant (Ultra-thin) +8 more— 510(k) K262108
Substantially EquivalentShanghai Personage Hygiene Products Co., Ltd.
FDA 510(k) clearance K262108 for FAMA Male Latex Condoms Aqueous Lubricant (Ultra-thin) +8 more, Substantially Equivalent on 2026-09-21. Applicant: Shanghai Personage Hygiene Products Co., Ltd.. Device class: 2.
Summary
Shanghai Personage Hygiene Products Co., Ltd. filed this one under product code HIS (Condom). The device name lists FAMA and MO Male Latex Condoms Aqueous Lubricant in Ultra-thin, Plain, Ribbed, Dotted, and Non-regular Shaped versions. The name is cut off in the record partway through the MO entries, so the full list isn't shown.
Class II, 21 CFR 884.5300. Obstetrics/Gynecology is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.
The company filed from Shanghai, China. The decision came 90 calendar days after receipt (June 23 to September 21, 2026).
Clearance details
- Device name as filed
- 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
- Applicant
- Shanghai Personage Hygiene Products Co., Ltd.
- Product code
- Product code HIS
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Recent devices under product code HIS
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