Disposable Surgical Isolation Gown
K-Number: K212422 · 2022-04-29
Decision Date2022-04-29
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Disposable Surgical Isolation Gown is a medical device manufactured by Crown Name Disposable Hygiene Products Fty., Ltd.. It received FDA 510(k) clearance on 2022-04-29 under approval number K212422. 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 Isolation Gown?
Disposable Surgical Isolation Gown is a medical device that received FDA 510(k) clearance on 2022-04-29. It is manufactured by Crown Name Disposable Hygiene Products Fty., Ltd.. The 510(k) number is K212422.
When was Disposable Surgical Isolation Gown approved by the FDA?
Disposable Surgical Isolation Gown received FDA 510(k) clearance on 2022-04-29, under approval number K212422.
What company makes Disposable Surgical Isolation Gown?
Disposable Surgical Isolation Gown is manufactured by Crown Name Disposable Hygiene Products Fty., Ltd..
What is the FDA product code for Disposable Surgical Isolation Gown?
The FDA product code for Disposable Surgical Isolation Gown is FYC.
Other Devices by Crown Name Disposable Hygiene Products Fty., 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.