AAMI4 Isolation Gown
K-Number: K214116 · 2022-10-11
ApplicantHubei Xinxin Non-Woven Co., Ltd.
Decision Date2022-10-11
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
AAMI4 Isolation Gown is a medical device manufactured by Hubei Xinxin Non-Woven Co., Ltd.. It received FDA 510(k) clearance on 2022-10-11 under approval number K214116. 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 AAMI4 Isolation Gown?
AAMI4 Isolation Gown is a medical device that received FDA 510(k) clearance on 2022-10-11. It is manufactured by Hubei Xinxin Non-Woven Co., Ltd.. The 510(k) number is K214116.
When was AAMI4 Isolation Gown approved by the FDA?
AAMI4 Isolation Gown received FDA 510(k) clearance on 2022-10-11, under approval number K214116.
What company makes AAMI4 Isolation Gown?
AAMI4 Isolation Gown is manufactured by Hubei Xinxin Non-Woven Co., Ltd..
What is the FDA product code for AAMI4 Isolation Gown?
The FDA product code for AAMI4 Isolation Gown is FYC.
Other Devices by Hubei Xinxin Non-Woven 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.