Microthin Natural Rubber Latex Condom
K-Number: K213921 · 2022-04-28
ApplicantSuretex Limited
Decision Date2022-04-28
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Microthin Natural Rubber Latex Condom is a medical device manufactured by Suretex Limited. It received FDA 510(k) clearance on 2022-04-28 under approval number K213921. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Microthin Natural Rubber Latex Condom?
Microthin Natural Rubber Latex Condom is a medical device that received FDA 510(k) clearance on 2022-04-28. It is manufactured by Suretex Limited. The 510(k) number is K213921.
When was Microthin Natural Rubber Latex Condom approved by the FDA?
Microthin Natural Rubber Latex Condom received FDA 510(k) clearance on 2022-04-28, under approval number K213921.
What company makes Microthin Natural Rubber Latex Condom?
Microthin Natural Rubber Latex Condom is manufactured by Suretex Limited.
What is the FDA product code for Microthin Natural Rubber Latex Condom?
The FDA product code for Microthin Natural Rubber Latex Condom is HIS.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.