Microthin Natural Rubber Latex Condom— 510(k) K213921

Name: FDA 510(k) clearance K213921
Creator: U.S. Food and Drug Administration
Published: 2022-04-28

Substantially Equivalent

Suretex Limited

FDA 510(k) clearance K213921 for Microthin Natural Rubber Latex Condom, Substantially Equivalent on 2022-04-28. Applicant: Suretex Limited. Device class: 2.

Clearance details

Applicant: Suretex Limited
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2021-12-15
Decision date: 2022-04-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tambon Khao Kwai, Amphur Phunphin, TH

Download summary PDF View on FDA.gov ↗

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