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510(k) Data Aggregation

    K Number
    K242689
    Device Name
    AAMI Level 4 Protective; Gown
    Manufacturer
    AZAC Group
    Date Cleared
    2025-01-13

    (129 days)

    Product Code
    QPC
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    QPC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AAMI Level 4 Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The AAMI Level 4 Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012 - Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities; but has an open back which is non-protective. The AAMI Level 4 Protective Gown is a single use, disposable medical device and is provided non-sterile.
    Device Description
    The AAMI Level 4 Protective Gown is a single use, disposable medical device and is provided non-sterile. It has an open back which is non-protective.
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    K Number
    K233526
    Device Name
    Medline Open-back Level 3 Protective Gown
    Manufacturer
    Medline Industries, LP
    Date Cleared
    2024-03-05

    (125 days)

    Product Code
    QPC, OPC
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    QPC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gown is a single use, disposable, non-solation gown intended to be worn by healthcare personnel to provide moderate barrier protection (AAMI Level 3) in non-sterile and non-patient isolation situations.
    Device Description
    The Medline Open-Back Level 3 Protective Gown is a single use, disposable, non-sterile, nonisolation gown intended to be worn by healthcare personnel to provide moderate barrier protection (AAMI Level 3) in non-sterile and non-patient isolation situation. The Medline Open-Back Level 3 Protective Gown meets the level 3 barrier protection requirements in accordance with ANSI/AAMI Standard PB70:2012 "Liquid Barrier Performance and Classification of Protective Apparel and Drapes intended for use in Health Care Facilities". The Medline Open-Back Level 3 Protective Gown is a blue polyethylene gown available in 3 configurations: regular/large, universal and XL. The gown has an open back with a tie for securement and thumb loops on the cuffs.
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    K Number
    K230384
    Device Name
    PolyWear® Personal Protective Level 3 Gown
    Manufacturer
    Polyconversions, INC
    Date Cleared
    2023-08-11

    (178 days)

    Product Code
    QPC, OPC
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    QPC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PolyWear® Personal Protection Level 3 Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The PolyWear® Personal Protection Level 3 Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room. The PolyWear® Personal Protection Level 3 Gown meets the requirements of AAMI Level 3 barrier protection for a protective gown per ANSI/AAMI PB70: 2012 Liquid Barrier Performance and Classification of protective apparel and drapes intended for use in healthcare facilities (AAMI PB70).
    Device Description
    The PolyWear® Personal Protection Level 3 Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective.
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    K Number
    K222128
    Device Name
    Protective Gown AAMI Level 4
    Manufacturer
    Kenpax International Limited
    Date Cleared
    2023-08-08

    (386 days)

    Product Code
    QPC, OPC
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    QPC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Protective gown AAMI Level 4 is intended to protect health care personnel and patients from transfer of microorganisms, body fluids and particulate material. The Protective Gowns is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.
    Device Description
    Protective Gown AAMI Level 4
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    K Number
    K212464
    Device Name
    Dukal Corporation AAMI Level 4 Open-Back Protective Gown
    Manufacturer
    Dukal Corporation
    Date Cleared
    2022-03-30

    (236 days)

    Product Code
    QPC, OPC
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    QPC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dukal AAMI Level 4 Open-Back Protective Gowns are intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. These gowns are not intended for use in the operating room. The Dukal AAMI Level 4 Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/A AMI PB70, Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, but has an open back which is non-protective. These gowns are single use, disposable medical devices provided non-sterile.
    Device Description
    Dukal AAMI Level 4 Open-Back Protective Gowns are intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material These gowns are not intended - for use in the operating room. The gowns are available on Regular and X-Large sizes. Dukal AAMI Level 4 Open-Back Protective Gowns are made with laminate material (SMS nonwoven material with polyethylene film). All gowns are blue, with neck removal feature, belt ties, and thumb hook cuff sleeves. These gowns are single use, disposable devices, that are provided non-sterile.
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    K Number
    K203821
    Device Name
    Donagamex Blue Performance Protective Gown
    Manufacturer
    Dong Nai Garment Corporation (Donagamex)
    Date Cleared
    2021-12-17

    (353 days)

    Product Code
    QPC, OPC
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    QPC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Donagamex protective gowns are non-sterile, single use surgical apparel intended to be worn by healthcare persomel to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter. The Donagamex protective gowns meet the requirements of AAMI Level 3 barrier protection for a protective gown per ANSI/A AMI PB70: 2012 Liquid Barrier Performance and Classification of protective apparel and drapes intended for use in healthcare facilities (AAMI PB70). The Donagamex protective gowns are sold non-sterile, single use. They are not intended for use in the operating room.
    Device Description
    The Donagamex Blue Performance Protective Gown is a Class II medical device under the FDA product code QPC, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Donagamex Blue Performance Protective Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993. The Donagamex Blue Performance Protective Gowns are non-woven, blue gowns, available in various sizes and have no areas of reinforcement. They are made from a layer of polyethylene laminated over spun-bonded polypropylene and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a protective gown. The Donagamex Blue Performance Protective Gown is a single use, disposable medical device that will be sold non-sterile.
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    K Number
    K210405
    Device Name
    ProTEC-USA EZDoff Gown
    Manufacturer
    Cadillac Products, Inc.
    Date Cleared
    2021-12-15

    (308 days)

    Product Code
    QPC, OPC
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    QPC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProTEC-USA EZDoff Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The ProTEC-USA EZDoff Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.
    Device Description
    The ProTEC-USA EZDoff Gown is constructed of 41 gsm blue polyolefin (Polyethylene) film offered in one universal size. The body of the gown is provided with belt ties that are constructed of the same 41 gsm blue polyolefin (Polyethylene) film. The sleeves of the gown are sealed using a heat-sealing method.
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    K Number
    K182830
    Device Name
    Cardinal HealthTM Poly-Coated Open-Back Protective Gown
    Manufacturer
    Cardinal Health 200, LLC
    Date Cleared
    2019-04-26

    (203 days)

    Product Code
    QPC, FYC
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    QPC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cardinal Health™ Poly-Coated Open-Back Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Not intended for use in the operating room. The proposed Cardinal Health™ Poly-Coated Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, but has an open back which is non-protective. The Cardinal Health™ Poly-Coated Open-Back Protective Gowns is a single use, disposable medical device provided non-sterile.
    Device Description
    The Cardinal Health™ Poly-Coated Open-Back Protective Gown is a Class II medical device under the FDA product code of FYC, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Cardinal Health™ Poly-Coated Open-Back Protective Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and Guidance for Industry and FDA Staff: Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings, issued on December 9, 2015. The Cardinal Health™ Poly-Coated Open-Back Protective Gown consists of a laminate (blue spunbond polypropylene coated with polyethylene) throughout the body of the gown (including sleeves). The sleeves have a thumbhook cuff formed into the sleeve or have a knit cuff sewn onto sleeve for keeping the sleeves in place on the wearer. The collar has a neck removal feature and the belt ties are integrated into the body. These gowns are non-sterile, single use, disposable gowns that are packaged in pastic bags and/or dispenser boxes. These gowns are offered in blue and come in both Universal and XX-Large sizes.
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    K Number
    K160337
    Device Name
    Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
    Manufacturer
    BAM CORPORATION LIMITED
    Date Cleared
    2017-07-07

    (515 days)

    Product Code
    QPC, FYC
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    QPC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The back of the gown is open and non-protective . They are not intended for use in the operating room.
    Device Description
    SafeCare® Open Back Protective Gowns (Models: 46969-097X, 46969097XB, 46969097X-10, 46969-098 & 46969-098D) and ValueCare® Open Back (Model: 4550-25X) Protective Gowns are open back gowns made from extruded plastic film. The SafeCare® and ValueCare® Open Back Protective gowns provide barrier protection to the wearer from body fluids and particulate materials and have passed barrier testing according to ANSI/AAMI PB70:2012 Level 3 protection or equivalent. The significant design points of the gowns are: 1. Made from extruded plastic film to provide an effective barrier meeting the requirements for penetration testing as per ANSI/AAMI PB70: 2012 Level 3 according to AATCC 42:2013 and AATCC 127:2014 test methods. 2. Backless to provide comfort 3. Thumb loops at the wrist which help to hold gown sleeves down 4. Back has perforations so the gowns can be removed without taking over the head in case they are contaminated
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