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FDA 510(k)

OREX SURGEON'S GOWN

K-Number: K944827 · 1995-02-28

ApplicantThantex Specialties, Inc.
Decision Date1995-02-28
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OREX SURGEON'S GOWN is the device name listed in this FDA 510(k) record. The listed applicant is Thantex Specialties, Inc.. It received FDA 510(k) clearance on 1995-02-28 under 510(k) number K944827. 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 OREX SURGEON'S GOWN?

OREX SURGEON'S GOWN is a medical device that received FDA 510(k) clearance on 1995-02-28. The listed applicant is Thantex Specialties, Inc.. The 510(k) number is K944827.

When did OREX SURGEON'S GOWN receive FDA 510(k) clearance?

OREX SURGEON'S GOWN received FDA 510(k) clearance on 1995-02-28, under 510(k) number K944827.

Who is the listed applicant for OREX SURGEON'S GOWN?

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

What is the FDA product code for OREX SURGEON'S GOWN?

The FDA product code for OREX SURGEON'S GOWN is FYA.

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Other records listing Thantex Specialties, 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.

K970547ISOLYSER SDS SHARPS CONTAINERK961083OREX SURGEON'S VESTK942200ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPSK943626ISOLYSER SHARPS MANAGEMENT SYSTEM SMSK945755OREX(R) O.R EQUIPMENT DRAPESK945223OREX ISOLATION GOWN

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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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