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FDA 510(k)

Protect X Level 3 Isolation Gown

K-Number: K211538 · 2021-11-17

ApplicantAzac Group
Decision Date2021-11-17
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Protect X Level 3 Isolation Gown is the device name listed in this FDA 510(k) record. The listed applicant is Azac Group. It received FDA 510(k) clearance on 2021-11-17 under 510(k) number K211538. 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 Protect X Level 3 Isolation Gown?

Protect X Level 3 Isolation Gown is a medical device that received FDA 510(k) clearance on 2021-11-17. The listed applicant is Azac Group. The 510(k) number is K211538.

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

Protect X Level 3 Isolation Gown received FDA 510(k) clearance on 2021-11-17, under 510(k) number K211538.

Who is the listed applicant for Protect X Level 3 Isolation Gown?

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

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

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

Other records listing Azac Group 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.

K242689AAMI Level 4 Protective; Gown

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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