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FDA 510(k)

GOWN, ISOLATION, SURGICAL (FYC)

K-Number: K882281 · 1988-06-23

ApplicantA Plus International, Inc.
Decision Date1988-06-23
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GOWN, ISOLATION, SURGICAL (FYC) is the device name listed in this FDA 510(k) record. The listed applicant is A Plus International, Inc.. It received FDA 510(k) clearance on 1988-06-23 under 510(k) number K882281. 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 GOWN, ISOLATION, SURGICAL (FYC)?

GOWN, ISOLATION, SURGICAL (FYC) is a medical device that received FDA 510(k) clearance on 1988-06-23. The listed applicant is A Plus International, Inc.. The 510(k) number is K882281.

When did GOWN, ISOLATION, SURGICAL (FYC) receive FDA 510(k) clearance?

GOWN, ISOLATION, SURGICAL (FYC) received FDA 510(k) clearance on 1988-06-23, under 510(k) number K882281.

Who is the listed applicant for GOWN, ISOLATION, SURGICAL (FYC)?

The FDA 510(k) record lists A Plus International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GOWN, ISOLATION, SURGICAL (FYC)?

The FDA product code for GOWN, ISOLATION, SURGICAL (FYC) is FYC.

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Other records listing A Plus International, Inc. as applicant

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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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