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FDA 510(k)

ISOLATION GOWNS

K-Number: K922442 · 1993-10-12

ApplicantPfb Inter-Apparel Corp.
Decision Date1993-10-12
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ISOLATION GOWNS is the device name listed in this FDA 510(k) record. The listed applicant is Pfb Inter-Apparel Corp.. It received FDA 510(k) clearance on 1993-10-12 under 510(k) number K922442. 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 GOWNS?

ISOLATION GOWNS is a medical device that received FDA 510(k) clearance on 1993-10-12. The listed applicant is Pfb Inter-Apparel Corp.. The 510(k) number is K922442.

When did ISOLATION GOWNS receive FDA 510(k) clearance?

ISOLATION GOWNS received FDA 510(k) clearance on 1993-10-12, under 510(k) number K922442.

Who is the listed applicant for ISOLATION GOWNS?

The FDA 510(k) record lists Pfb Inter-Apparel Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOLATION GOWNS?

The FDA product code for ISOLATION GOWNS is FYC.

Related Clinical Trials

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.

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Other records listing Pfb Inter-Apparel Corp. 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.

K924335DRAPES

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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