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FDA 510(k)

IMPERVIOUS ISOLATION GOWN

K-Number: K972410 · 1997-09-19

ApplicantKentron Health Care, Inc.
Decision Date1997-09-19
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMPERVIOUS ISOLATION GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Kentron Health Care, Inc.. It received FDA 510(k) clearance on 1997-09-19 under 510(k) number K972410. 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 IMPERVIOUS ISOLATION GOWN?

IMPERVIOUS ISOLATION GOWN is a medical device that received FDA 510(k) clearance on 1997-09-19. The listed applicant is Kentron Health Care, Inc.. The 510(k) number is K972410.

When did IMPERVIOUS ISOLATION GOWN receive FDA 510(k) clearance?

IMPERVIOUS ISOLATION GOWN received FDA 510(k) clearance on 1997-09-19, under 510(k) number K972410.

Who is the listed applicant for IMPERVIOUS ISOLATION GOWN?

The FDA 510(k) record lists Kentron Health Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPERVIOUS ISOLATION GOWN?

The FDA product code for IMPERVIOUS ISOLATION GOWN is FYC.

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Other records listing Kentron Health Care, Inc. 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.

K030693KENTEX DISPOSABLE VAGINAL SPECULUMK971917KENTRON'S ISOLATION GOWNK953465KENTEMPK953914KENTEXK953830KENSORB

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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