FAMA Male Latex Condoms— 510(k) K220576

Name: FDA 510(k) clearance K220576
Creator: U.S. Food and Drug Administration
Published: 2022-08-05

Substantially Equivalent

Shanghai Personage Hygiene Products Co., Ltd.

FDA 510(k) clearance K220576 for FAMA Male Latex Condoms, Substantially Equivalent on 2022-08-05. Applicant: Shanghai Personage Hygiene Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Personage Hygiene Products Co., Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2022-02-28
Decision date: 2022-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qingpu District, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.