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FDA 510(k)

BREATHABLE SURGICAL GOWN

K-Number: K023167 · 2002-10-02

ApplicantAllegiance Healthcare Corp.
Decision Date2002-10-02
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BREATHABLE SURGICAL GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Allegiance Healthcare Corp.. It received FDA 510(k) clearance on 2002-10-02 under 510(k) number K023167. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATHABLE SURGICAL GOWN?

BREATHABLE SURGICAL GOWN is a medical device that received FDA 510(k) clearance on 2002-10-02. The listed applicant is Allegiance Healthcare Corp.. The 510(k) number is K023167.

When did BREATHABLE SURGICAL GOWN receive FDA 510(k) clearance?

BREATHABLE SURGICAL GOWN received FDA 510(k) clearance on 2002-10-02, under 510(k) number K023167.

Who is the listed applicant for BREATHABLE SURGICAL GOWN?

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

What is the FDA product code for BREATHABLE SURGICAL GOWN?

The FDA product code for BREATHABLE SURGICAL GOWN is FYA.

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Other records listing Allegiance Healthcare Corp. as applicant

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K023673AIRLIFE DEMAND NASAL CANNULAK023419TRILAMINATE DRAPES/TIBURONK024120MODIFICATION TO TEMNO BIOPSY NEEDLESK024292MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIMK024102DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMK023425DRAPES WITH ABSORBENT REINFORCEMENT

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Related Devices (Code: FYA)

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.

K260407Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation GownsPrinciple & Will Co., Ltd.K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 Disposable GownsNew York Embroidery StudioK252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™ Poly Reinforced Surgical GownCardinal Health 200, 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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