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FDA 510(k)

STERILE BACK SURGICAL GOWN WITH HAND TOWEL

K-Number: K984422 · 1999-04-02

ApplicantMedical Sterilization, Inc.
Decision Date1999-04-02
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE BACK SURGICAL GOWN WITH HAND TOWEL is the device name listed in this FDA 510(k) record. The listed applicant is Medical Sterilization, Inc.. It received FDA 510(k) clearance on 1999-04-02 under 510(k) number K984422. 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 STERILE BACK SURGICAL GOWN WITH HAND TOWEL?

STERILE BACK SURGICAL GOWN WITH HAND TOWEL is a medical device that received FDA 510(k) clearance on 1999-04-02. The listed applicant is Medical Sterilization, Inc.. The 510(k) number is K984422.

When did STERILE BACK SURGICAL GOWN WITH HAND TOWEL receive FDA 510(k) clearance?

STERILE BACK SURGICAL GOWN WITH HAND TOWEL received FDA 510(k) clearance on 1999-04-02, under 510(k) number K984422.

Who is the listed applicant for STERILE BACK SURGICAL GOWN WITH HAND TOWEL?

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

What is the FDA product code for STERILE BACK SURGICAL GOWN WITH HAND TOWEL?

The FDA product code for STERILE BACK SURGICAL GOWN WITH HAND TOWEL is FYA.

Related Clinical Trials

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.

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Other records listing Medical Sterilization, 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.

K912803MSI STERILE BACK SURGICAL GOWN PACK HAND TOWELK843564MSI SURGI-GRADE SUTURE TRAYK843562MSI SURGI-GRADE DELUXE CUT-DOWN TRAYK843561MSI SURGI-GRADE UNIVERSAL TRACH TRAYK843563MSI SURGI-GRADE INCISION & DRAIN TRAY

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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