Male Latex Condoms
K-Number: K222611 · 2022-11-28
Decision Date2022-11-28
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Male Latex Condoms is a medical device manufactured by Suzhou Colour-Way New Material Co., Ltd.. It received FDA 510(k) clearance on 2022-11-28 under approval number K222611. 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 Male Latex Condoms?
Male Latex Condoms is a medical device that received FDA 510(k) clearance on 2022-11-28. It is manufactured by Suzhou Colour-Way New Material Co., Ltd.. The 510(k) number is K222611.
When was Male Latex Condoms approved by the FDA?
Male Latex Condoms received FDA 510(k) clearance on 2022-11-28, under approval number K222611.
What company makes Male Latex Condoms?
Male Latex Condoms is manufactured by Suzhou Colour-Way New Material Co., Ltd..
What is the FDA product code for Male Latex Condoms?
The FDA product code for Male Latex Condoms is HIS.
Other Devices by Suzhou Colour-Way New Material Co., Ltd.
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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.