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FDA 510(k)

Isolation Gown AAMI Level 3

K-Number: K212504 · 2021-11-07

ApplicantKenpax International Limited
Decision Date2021-11-07
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Isolation Gown AAMI Level 3 is the device name listed in this FDA 510(k) record. The listed applicant is Kenpax International Limited. It received FDA 510(k) clearance on 2021-11-07 under 510(k) number K212504. 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 Isolation Gown AAMI Level 3?

Isolation Gown AAMI Level 3 is a medical device that received FDA 510(k) clearance on 2021-11-07. The listed applicant is Kenpax International Limited. The 510(k) number is K212504.

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

Isolation Gown AAMI Level 3 received FDA 510(k) clearance on 2021-11-07, under 510(k) number K212504.

Who is the listed applicant for Isolation Gown AAMI Level 3?

The FDA 510(k) record lists Kenpax International Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Isolation Gown AAMI Level 3?

The FDA product code for Isolation Gown AAMI Level 3 is FYC.

Other records listing Kenpax International Limited 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.

K222128Protective Gown AAMI Level 4K222151Sterilization WrapK202899Procedure Mask, Surgical Mask

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.

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.

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