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FDA 510(k)

BARRIER SURGICAL GOWNS

K-Number: K990395 · 1999-04-13

ApplicantJohnson & Johnson Medical, Div. of Ethicon, Inc.
Decision Date1999-04-13
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARRIER SURGICAL GOWNS is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Medical, Div. of Ethicon, Inc.. It received FDA 510(k) clearance on 1999-04-13 under 510(k) number K990395. 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 BARRIER SURGICAL GOWNS?

BARRIER SURGICAL GOWNS is a medical device that received FDA 510(k) clearance on 1999-04-13. The listed applicant is Johnson & Johnson Medical, Div. of Ethicon, Inc.. The 510(k) number is K990395.

When did BARRIER SURGICAL GOWNS receive FDA 510(k) clearance?

BARRIER SURGICAL GOWNS received FDA 510(k) clearance on 1999-04-13, under 510(k) number K990395.

Who is the listed applicant for BARRIER SURGICAL GOWNS?

The FDA 510(k) record lists Johnson & Johnson Medical, Div. of Ethicon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARRIER SURGICAL GOWNS?

The FDA product code for BARRIER SURGICAL GOWNS is FYA.

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Other records listing Johnson & Johnson Medical, Div. of Ethicon, Inc. 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.

K990236MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECTK983240NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVESK983234TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSINGK983394MODIFICATION TO TIELLE HYDROPOLMER DRESSING

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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