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FDA 510(k)

Plus Medical Isolation Gown Level 3

K-Number: K212698 · 2022-03-02

Decision Date2022-03-02
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Plus Medical Isolation Gown Level 3 is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Nanhai Plus Medical Co, Ltd.. It received FDA 510(k) clearance on 2022-03-02 under 510(k) 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. The listed applicant is Foshan Nanhai Plus Medical Co, Ltd.. The 510(k) number is K212698.

When did Plus Medical Isolation Gown Level 3 receive FDA 510(k) clearance?

Plus Medical Isolation Gown Level 3 received FDA 510(k) clearance on 2022-03-02, under 510(k) number K212698.

Who is the listed applicant for Plus Medical Isolation Gown Level 3?

The FDA 510(k) record lists Foshan Nanhai Plus Medical Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Foshan Nanhai Plus Medical Co, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: FYC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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