FDA 510(k)

AAMI3 Isolation Gown

K-Number: K213832 · 2022-05-16

ApplicantHubei Xinxin Non-Woven Co., Ltd.

Decision Date2022-05-16

Product CodeFYC

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AAMI3 Isolation Gown is the device name listed in this FDA 510(k) record. The listed applicant is Hubei Xinxin Non-Woven Co., Ltd.. It received FDA 510(k) clearance on 2022-05-16 under 510(k) number K213832. 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 AAMI3 Isolation Gown?

AAMI3 Isolation Gown is a medical device that received FDA 510(k) clearance on 2022-05-16. The listed applicant is Hubei Xinxin Non-Woven Co., Ltd.. The 510(k) number is K213832.

When did AAMI3 Isolation Gown receive FDA 510(k) clearance?

AAMI3 Isolation Gown received FDA 510(k) clearance on 2022-05-16, under 510(k) number K213832.

Who is the listed applicant for AAMI3 Isolation Gown?

The FDA 510(k) record lists Hubei Xinxin Non-Woven Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AAMI3 Isolation Gown?

The FDA product code for AAMI3 Isolation Gown is FYC.

Other records listing Hubei Xinxin Non-Woven 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.

K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)K214116AAMI4 Isolation Gown K212120Surgical Masks

Related Devices (Code: FYC)

K232849Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)Owens & Minor (O&M) Halyard, Inc.K230135Copioumed Chemotherapy Isolation GownCopioumed International, Inc.K223467Disposable Isolation GownNanning Tecbod Biological Technology Co., Ltd.K223304Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Technology Co., Ltd.K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd.K212717Paneffort AAMI Level 3 Isolation GownPaneffort, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.