The SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.


Product Overview

The SMS Reinforced Gown is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is made from SMS material, and is full length, constructed with raglan sleeves, hook and loop neck closures, and tie waist closures. The reinforcement has the following structural features: (a) The chest area is reinforced with additional layer of SMS material. (b) The sleeve area is reinforced with additional layer of SMS material. Non
SMS Reinforced Surgical Gown (Non-Sterile)-M - JCSG74700M


Device Description

A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

  • Ethylene Oxide
    • Ethylene Oxide


    Product Codes

    Code: FYA

    Device Name: Gown, Surgical

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: HO

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 878.4040

    Third Party Flag: N

    Medical Specialty: SU


    Device Identifiers

    Device Id: 14710415369144

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 04710415369147

    Package Quantity: 25

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Carton


    Device Id: 04710415369147

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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