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FDA 510(k)

Medline Non-Surgical Isolation Gown-

K-Number: K160471 · 2017-01-31

ApplicantMedline Industries, Inc.
Decision Date2017-01-31
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline Non-Surgical Isolation Gown- is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2017-01-31 under 510(k) number K160471. 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 Medline Non-Surgical Isolation Gown-?

Medline Non-Surgical Isolation Gown- is a medical device that received FDA 510(k) clearance on 2017-01-31. The listed applicant is Medline Industries, Inc.. The 510(k) number is K160471.

When did Medline Non-Surgical Isolation Gown- receive FDA 510(k) clearance?

Medline Non-Surgical Isolation Gown- received FDA 510(k) clearance on 2017-01-31, under 510(k) number K160471.

Who is the listed applicant for Medline Non-Surgical Isolation Gown-?

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

What is the FDA product code for Medline Non-Surgical Isolation Gown-?

The FDA product code for Medline Non-Surgical Isolation Gown- is FYC.

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Related Devices (Code: FYC)

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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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