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    K Number
    K221819
    Device Name
    35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown
    Manufacturer
    Winner Medical Co., Ltd.
    Date Cleared
    2022-09-19

    (88 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K211422,K192290
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

    Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, 35g Standard SMMS Surgical Gown met the requirements for Level 2 classification; 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown met the requirements for Level 3 classification; BVB Surgical gown met the requirements for Level 4 classification. Non-sterile gowns are to be sold to repackager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to the end users after EtO sterilization to ISO 11135-1.

    Device Description

    The proposed devices are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and are provided in sterile and non-sterile. For non-sterile surgical gowns, they shall be sterilized by EO prior to use.

    The proposed devices are available in two materials, SMMS and BVB. SMMS surgical gowns are available in three gram weights, 35g/m², 43g/m², while BVB surgical gown is available only in 64g/m². All SMMS surgical gowns are provided in two types, standard and reinforced. And all types of SMMS surgical gown and BVB surgical gown are available in six product sizes, including M, L, LL, XL, XLL and XXL.

    The barrier protection level for 35g Standard SMMS Surgical Gown meet AAMI Level 2; The barrier protection level for 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown meet AAMI Level 3; The barrier protection level for BVB Surgical gown meet AAMI Level 4.

    AI/ML Overview

    The provided text describes the non-clinical testing of surgical gowns to demonstrate their substantial equivalence to predicate devices, rather than a study for an AI/ML device. Therefore, the requested information regarding AI/ML device acceptance criteria, performance, ground truth, experts, and training/test set details cannot be extracted from this document.

    However, I can provide the acceptance criteria and performance results for the physical properties and biocompatibility of the surgical gowns based on the provided tables.

    1. A table of acceptance criteria and the reported device performance

    Test MethodologyAcceptance CriteriaReported Device Performance
    FlammabilityMeets Class 1 requirementsClass 1
    Hydrostatic pressureLevel 2 Surgical Gown: >20 cm H2O; Level 3 Surgical Gown: >50 cm H2O; Level 4 Surgical Gown: >50 cm H2O35g Standard SMMS Surgical Gown: (Non-sterile): Average 40.57cm; (Sterile): Average 40.21cm (Meets Level 2)
    35g Reinforced SMMS Surgical Gown: (Non-sterile): Average 83.53cm; (Sterile): Average 83.57cm (Meets Level 3)
    43g Standard SMMS Surgical Gown: (Non-sterile): Average 60.50 cm; (Sterile): Average 60.48 cm (Meets Level 3)
    43g Reinforced SMMS Surgical Gown: (Non-sterile): Average 99.59 cm; (Sterile): Average 98.90 cm (Meets Level 3)
    50g Standard SMMS Surgical Gown: (Non-sterile): Average 83.19 cm; (Sterile): Average 83.02 cm (Meets Level 3)
    50g Reinforced SMMS Surgical Gown: (Non-sterile): Average 108.37 cm; (Sterile): Average 108.37 cm (Meets Level 3)
    BVB Surgical Gown: (Non-sterile): Average 161.71 cm; (Sterile): Average 162.11 cm (Meets Level 4)
    Water impact≤1.0 g35g Standard SMMS Surgical Gown: (Non-sterile): Average 0.041g; (Sterile): Average 0.03g
    35g Reinforced SMMS Surgical Gown: (Non-sterile): Average 0.03g; (Sterile): Average 0.029g
    43g Standard SMMS Surgical Gown: (Non-sterile): Average 0.036g; (Sterile): Average 0.033g
    43g Reinforced SMMS Surgical Gown: (Non-sterile): Average 0.032g; (Sterile): Average 0.032g
    50g Standard SMMS Surgical Gown: (Non-sterile): Average 0.031g; (Sterile): Average 0.034g
    50g Reinforced SMMS Surgical Gown: (Non-sterile): Average 0.033g; (Sterile): Average 0.031g
    BVB Surgical Gown: (Non-sterile): Average 0.078g; (Sterile): Average 0.079g (All meet criteria)
    Breaking strength≥30N35g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 108.37N; Longitude: 161.87N; (Sterile): Latitude: 108.37N; Longitude: 161.87N
    35g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 108.72N; Longitude: 161.19N; (Sterile): Latitude: 108.53N; Longitude: 161.31N
    43g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 113.34N; Longitude: 182.30N; (Sterile): Latitude: 113.01N; Longitude: 181.05N
    43g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 113.72N; Longitude: 181.14N; (Sterile): Latitude: 112.60N; Longitude: 181.26N
    50g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 137.58N; Longitude: 190.87N; (Sterile): Latitude: 137.77N; Longitude: 188.30N
    50g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 138.02N; Longitude: 191.32N; (Sterile): Latitude: 138.39N; Longitude: 190.07N
    BVB Surgical Gown: (Non-sterile): Latitude: 148.44N; Longitude: 236.60N; (Sterile): Latitude: 148.93N; Longitude: 237.72N (All values significantly greater than 30N)
    Tearing strength≥10N35g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 32.49N; Longitude: 39.67N; (Sterile): Latitude: 32.31N; Longitude: 39.81N
    35g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 32.44N; Longitude: 39.67N; (Sterile): Latitude: 32.55N; Longitude: 39.92N
    43g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 33.99N; Longitude: 41.40N; (Sterile): Latitude: 33.92N; Longitude: 41.75N
    43g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 34.09N; Longitude: 41.51N; (Sterile): Latitude: 34.01N; Longitude: 41.18N
    50g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 44.02N; Longitude: 54.18N; (Sterile): Latitude: 44.36N; Longitude: 54.07N
    50g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 43.93N; Longitude: 53.96N; (Sterile): Latitude: 44.30N; Longitude: 54.25N
    BVB Surgical Gown: (Non-sterile): Latitude: 49.76N; Longitude: 53.97N; (Sterile): Latitude: 49.23N; Longitude: 53.98N (All values significantly greater than 10N)
    LintingLog10(particle count)
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