FDA 510(k)

JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE

K-Number: K111067 · 2011-08-02

ApplicantKunshan Jiehong Nonwoven Product Co., Ltd.

Decision Date2011-08-02

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Kunshan Jiehong Nonwoven Product Co., Ltd.. It received FDA 510(k) clearance on 2011-08-02 under 510(k) number K111067. 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 JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE?

JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE is a medical device that received FDA 510(k) clearance on 2011-08-02. The listed applicant is Kunshan Jiehong Nonwoven Product Co., Ltd.. The 510(k) number is K111067.

When did JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE receive FDA 510(k) clearance?

JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE received FDA 510(k) clearance on 2011-08-02, under 510(k) number K111067.

Who is the listed applicant for JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE?

The FDA 510(k) record lists Kunshan Jiehong Nonwoven Product Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE?

The FDA product code for JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE is FYA.

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Other records listing Kunshan Jiehong Nonwoven Product Co., Ltd. as applicant

K112136TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE

Related Devices (Code: FYA)

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 Studio K252575Tuff 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.