FDA 510(k)

STERILE ISOLATION GOWN

K-Number: K801069 · 1980-05-20

Decision Date1980-05-20

Product CodeFYC

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

STERILE ISOLATION GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Medspec Corp.. It received FDA 510(k) clearance on 1980-05-20 under 510(k) number K801069. 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 STERILE ISOLATION GOWN?

STERILE ISOLATION GOWN is a medical device that received FDA 510(k) clearance on 1980-05-20. The listed applicant is Medspec Corp.. The 510(k) number is K801069.

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

STERILE ISOLATION GOWN received FDA 510(k) clearance on 1980-05-20, under 510(k) number K801069.

Who is the listed applicant for STERILE ISOLATION GOWN?

The FDA 510(k) record lists Medspec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE ISOLATION GOWN?

The FDA product code for STERILE ISOLATION GOWN is FYC.

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Other records listing Medspec Corp. as applicant

K813012STERILE BASIN SETS K812710STERILE LAPAROTOMY SPONGES-X-RAY DETECT K812707STERILE DISSECTOR SPONGES-X-RAY DETECT K812711STERILE GAUZE PADS 12PLY K812709STERILE DENTAL ROLL K810071STERILE SILICONE TUBING

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Related Devices (Code: FYC)

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.