Disposable Surgical Gowns
K-Number: K210785 · 2021-11-13
Decision Date2021-11-13
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable Surgical Gowns is a medical device manufactured by Chongqing Litai Fashion Group Limited Company. It received FDA 510(k) clearance on 2021-11-13 under approval number K210785. 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 Disposable Surgical Gowns?
Disposable Surgical Gowns is a medical device that received FDA 510(k) clearance on 2021-11-13. It is manufactured by Chongqing Litai Fashion Group Limited Company. The 510(k) number is K210785.
When was Disposable Surgical Gowns approved by the FDA?
Disposable Surgical Gowns received FDA 510(k) clearance on 2021-11-13, under approval number K210785.
What company makes Disposable Surgical Gowns?
Disposable Surgical Gowns is manufactured by Chongqing Litai Fashion Group Limited Company.
What is the FDA product code for Disposable Surgical Gowns?
The FDA product code for Disposable Surgical Gowns is FYC.
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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.