FAMA Male Latex Condoms
K-Number: K220576 · 2022-08-05
Decision Date2022-08-05
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
FAMA Male Latex Condoms is a medical device manufactured by Shanghai Personage Hygiene Products Co., Ltd.. It received FDA 510(k) clearance on 2022-08-05 under approval number K220576. 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 FAMA Male Latex Condoms?
FAMA Male Latex Condoms is a medical device that received FDA 510(k) clearance on 2022-08-05. It is manufactured by Shanghai Personage Hygiene Products Co., Ltd.. The 510(k) number is K220576.
When was FAMA Male Latex Condoms approved by the FDA?
FAMA Male Latex Condoms received FDA 510(k) clearance on 2022-08-05, under approval number K220576.
What company makes FAMA Male Latex Condoms?
FAMA Male Latex Condoms is manufactured by Shanghai Personage Hygiene Products Co., Ltd..
What is the FDA product code for FAMA Male Latex Condoms?
The FDA product code for FAMA Male Latex Condoms 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.