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Condom

FDA product code HIS · 392 cleared devices

Class 2 Obstetrics/Gynecology
Regulation
21 CFR 884.5300
Review panel
OB
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1977-06-17 – 2026-09-21
HIS 2026-09-21

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.

K number K262108

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