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FDA 510(k)

Cardinal Health Isolation Gown

K-Number: K160339 · 2016-07-28

ApplicantCardinal Health200, LLC
Decision Date2016-07-28
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cardinal Health Isolation Gown is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K160339. 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 Cardinal Health Isolation Gown?

Cardinal Health Isolation Gown is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K160339.

When did Cardinal Health Isolation Gown receive FDA 510(k) clearance?

Cardinal Health Isolation Gown received FDA 510(k) clearance on 2016-07-28, under 510(k) number K160339.

Who is the listed applicant for Cardinal Health Isolation Gown?

The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardinal Health Isolation Gown?

The FDA product code for Cardinal Health Isolation Gown is FYC.

Other records listing Cardinal Health200, LLC 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.

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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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