Comfort Gown, Safewear Gown
K-Number: K213893 · 2022-12-21
Decision Date2022-12-21
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Comfort Gown, Safewear Gown is a medical device manufactured by Xuchang Zhengde Environstar Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-12-21 under approval number K213893. 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 Comfort Gown, Safewear Gown?
Comfort Gown, Safewear Gown is a medical device that received FDA 510(k) clearance on 2022-12-21. It is manufactured by Xuchang Zhengde Environstar Medical Products Co., Ltd.. The 510(k) number is K213893.
When was Comfort Gown, Safewear Gown approved by the FDA?
Comfort Gown, Safewear Gown received FDA 510(k) clearance on 2022-12-21, under approval number K213893.
What company makes Comfort Gown, Safewear Gown?
Comfort Gown, Safewear Gown is manufactured by Xuchang Zhengde Environstar Medical Products Co., Ltd..
What is the FDA product code for Comfort Gown, Safewear Gown?
The FDA product code for Comfort Gown, Safewear Gown is FYA.
Other Devices by Xuchang Zhengde Environstar 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.