Disposable Surgical Gown
K-Number: K212591 · 2022-01-11
Decision Date2022-01-11
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable Surgical Gown is a medical device manufactured by Suzhou Janee Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-11 under approval number K212591. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Disposable Surgical Gown?
Disposable Surgical Gown is a medical device that received FDA 510(k) clearance on 2022-01-11. It is manufactured by Suzhou Janee Medical Technology Co., Ltd.. The 510(k) number is K212591.
When was Disposable Surgical Gown approved by the FDA?
Disposable Surgical Gown received FDA 510(k) clearance on 2022-01-11, under approval number K212591.
What company makes Disposable Surgical Gown?
Disposable Surgical Gown is manufactured by Suzhou Janee Medical Technology Co., Ltd..
What is the FDA product code for Disposable Surgical Gown?
The FDA product code for Disposable Surgical Gown is FYA.
Other Devices by Suzhou Janee Medical Technology 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.