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FDA 510(k)

DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)

K-Number: K031408 · 2003-10-15

ApplicantDeroyal
Decision Date2003-10-15
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal. It received FDA 510(k) clearance on 2003-10-15 under 510(k) number K031408. 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 DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)?

DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) is a medical device that received FDA 510(k) clearance on 2003-10-15. The listed applicant is Deroyal. The 510(k) number is K031408.

When did DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) receive FDA 510(k) clearance?

DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) received FDA 510(k) clearance on 2003-10-15, under 510(k) number K031408.

Who is the listed applicant for DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)?

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

What is the FDA product code for DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)?

The FDA product code for DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) is FYA.

Related Clinical Trials

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Other records listing Deroyal 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.

K041416EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETERK033057DEROYAL SURGICAL GOWNS, STERILE, NON-STERILEK030908DEROYAL SURGICAL DRAPES BACKTABLE COVERK020753DEROYAL SURGICAL, UMBILICUP

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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