Male Latex Condoms— 510(k) K222611

Name: FDA 510(k) clearance K222611
Creator: U.S. Food and Drug Administration
Published: 2022-11-28

Substantially Equivalent

Suzhou Colour-Way New Material Co., Ltd.

FDA 510(k) clearance K222611 for Male Latex Condoms, Substantially Equivalent on 2022-11-28. Applicant: Suzhou Colour-Way New Material Co., Ltd.. Device class: 2.

Clearance details

Applicant: Suzhou Colour-Way New Material Co., Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2022-08-30
Decision date: 2022-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, 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.