Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
K-Number: K223304 · 2023-02-08
Decision Date2023-02-08
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) is a medical device manufactured by Xiamen Probtain Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-02-08 under approval number K223304. 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 Isolation Gowns (S,M,L,XL,XXL,XXXL)?
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) is a medical device that received FDA 510(k) clearance on 2023-02-08. It is manufactured by Xiamen Probtain Medical Technology Co., Ltd.. The 510(k) number is K223304.
When was Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) approved by the FDA?
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) received FDA 510(k) clearance on 2023-02-08, under approval number K223304.
What company makes Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)?
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) is manufactured by Xiamen Probtain Medical Technology Co., Ltd..
What is the FDA product code for Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)?
The FDA product code for Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) 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.