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FDA 510(k)

DISPOSABLE ISOLATION GOWN

K-Number: K851823 · 1985-05-17

ApplicantAmerican Threshold Industries, Inc.
Decision Date1985-05-17
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ISOLATION GOWN is the device name listed in this FDA 510(k) record. The listed applicant is American Threshold Industries, Inc.. It received FDA 510(k) clearance on 1985-05-17 under 510(k) number K851823. 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 DISPOSABLE ISOLATION GOWN?

DISPOSABLE ISOLATION GOWN is a medical device that received FDA 510(k) clearance on 1985-05-17. The listed applicant is American Threshold Industries, Inc.. The 510(k) number is K851823.

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

DISPOSABLE ISOLATION GOWN received FDA 510(k) clearance on 1985-05-17, under 510(k) number K851823.

Who is the listed applicant for DISPOSABLE ISOLATION GOWN?

The FDA 510(k) record lists American Threshold Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE ISOLATION GOWN?

The FDA product code for DISPOSABLE ISOLATION GOWN is FYC.

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Other records listing American Threshold Industries, 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.

K971483SECURE-WRAP (TM) STERILIZATION WRAPK953879SURGEON'S CAPK953878BOUFFANT CAPK952115BARRIER GOWN, KOOL-GARD BACKLESS GOWNK952114KOOL GARD SINGLES GOWNK952116COVER GOWN

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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

View on FDA Database →

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

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