FDA 510(k)

EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER

K-Number: K111535 · 2011-08-26

ApplicantExact Medical Manufacturing, Inc.

Decision Date2011-08-26

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER is the device name listed in this FDA 510(k) record. The listed applicant is Exact Medical Manufacturing, Inc.. It received FDA 510(k) clearance on 2011-08-26 under 510(k) number K111535. 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 EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER?

EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER is a medical device that received FDA 510(k) clearance on 2011-08-26. The listed applicant is Exact Medical Manufacturing, Inc.. The 510(k) number is K111535.

When did EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER receive FDA 510(k) clearance?

EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER received FDA 510(k) clearance on 2011-08-26, under 510(k) number K111535.

Who is the listed applicant for EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER?

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

What is the FDA product code for EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER?

The FDA product code for EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER is FYA.

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Other records listing Exact Medical Manufacturing, Inc. as applicant

K121919SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV K120045EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV K101598EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)K101689EMM EQUIPMENT COVER-POLYTHYLENE K101688EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 K101593EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.