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FDA 510(k)

MASTER & FRANK SURGICAL GOWNS (STERILE)

K-Number: K012186 · 2001-12-07

ApplicantMaster & Frank Ent. Co., Ltd.
Decision Date2001-12-07
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MASTER & FRANK SURGICAL GOWNS (STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Master & Frank Ent. Co., Ltd.. It received FDA 510(k) clearance on 2001-12-07 under 510(k) number K012186. 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 MASTER & FRANK SURGICAL GOWNS (STERILE)?

MASTER & FRANK SURGICAL GOWNS (STERILE) is a medical device that received FDA 510(k) clearance on 2001-12-07. The listed applicant is Master & Frank Ent. Co., Ltd.. The 510(k) number is K012186.

When did MASTER & FRANK SURGICAL GOWNS (STERILE) receive FDA 510(k) clearance?

MASTER & FRANK SURGICAL GOWNS (STERILE) received FDA 510(k) clearance on 2001-12-07, under 510(k) number K012186.

Who is the listed applicant for MASTER & FRANK SURGICAL GOWNS (STERILE)?

The FDA 510(k) record lists Master & Frank Ent. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MASTER & FRANK SURGICAL GOWNS (STERILE)?

The FDA product code for MASTER & FRANK SURGICAL GOWNS (STERILE) is FYA.

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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

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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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