Plus Medical Isolation Gown Level 3
K-Number: K212698 · 2022-03-02
ApplicantFoshan Nanhai Plus Medical Co, Ltd.
Decision Date2022-03-02
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Plus Medical Isolation Gown Level 3 is a medical device manufactured by Foshan Nanhai Plus Medical Co, Ltd.. It received FDA 510(k) clearance on 2022-03-02 under approval number K212698. 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 Plus Medical Isolation Gown Level 3?
Plus Medical Isolation Gown Level 3 is a medical device that received FDA 510(k) clearance on 2022-03-02. It is manufactured by Foshan Nanhai Plus Medical Co, Ltd.. The 510(k) number is K212698.
When was Plus Medical Isolation Gown Level 3 approved by the FDA?
Plus Medical Isolation Gown Level 3 received FDA 510(k) clearance on 2022-03-02, under approval number K212698.
What company makes Plus Medical Isolation Gown Level 3?
Plus Medical Isolation Gown Level 3 is manufactured by Foshan Nanhai Plus Medical Co, Ltd..
What is the FDA product code for Plus Medical Isolation Gown Level 3?
The FDA product code for Plus Medical Isolation Gown Level 3 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.