Surgical isolation gown
K-Number: K212357 · 2022-01-20
Decision Date2022-01-20
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical isolation gown is a medical device manufactured by Wuhan Zonsen Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-01-20 under approval number K212357. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Surgical isolation gown?
Surgical isolation gown is a medical device that received FDA 510(k) clearance on 2022-01-20. It is manufactured by Wuhan Zonsen Medical Products Co., Ltd.. The 510(k) number is K212357.
When was Surgical isolation gown approved by the FDA?
Surgical isolation gown received FDA 510(k) clearance on 2022-01-20, under approval number K212357.
What company makes Surgical isolation gown?
Surgical isolation gown is manufactured by Wuhan Zonsen Medical Products Co., Ltd..
What is the FDA product code for Surgical isolation gown?
The FDA product code for Surgical isolation gown is FYC.
Other Devices by Wuhan Zonsen Medical Products 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.