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510(k) Data Aggregation

    K Number
    K221559
    Device Name
    Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3
    Manufacturer
    StringKing
    Date Cleared
    2023-02-23

    (268 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K202706
    Why did this record match?
    Applicant Name (Manufacturer) :

    StringKing

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The StringKing Disposable Surgical Gown is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. The StringKing Surgical Gowns meet Level 3 and Level 4 requirements of ANSI/AAMI PB 70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

    Device Description

    The Disposable Surgical Gown consists of a multi-layer nonwoven spunbond-meltblownspunbond (SMS) polyolefin & Film Lamination in the critical zones and a single layer of lighter, more breathable nonwoven SMS polvolefin in the non-critical zones. The StringKing Disposable Surgical Gown is designed for easy donning and doffing with hook and loop neck tabs, belt ties, removable transfer accessory, and polyester wrist cuffs. The StringKing Disposable Surgical Gown is one gown design that meets both Level 4 requirements of AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The gown will be marketed as a L3 gown as well as a L4 gown. The StringKing Disposable Surgical Gowns are single use, disposable medical devices that will be provided sterile.

    AI/ML Overview

    Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test StandardAcceptance CriteriaReported Device PerformancePass/Fail
    ANSI/AAMI PB70:2012 (Overall classification)Meets Level 3 and Level 4 Liquid Barrier RequirementsMeets ANSI/AAMI PB 70:2012 Level 3 and Level 4 Liquid Barrier requirementsPass
    Water Resistance Hydrostatic Pressure Test - AATCC 127:2017 (cm)$\ge$ 50 cmAll samples passed at $\ge$ 50 cmPass
    Flammability of Clothing Textiles - 16 CFR Part 1610 (a)Class 1: $\ge$ 3.5 secondsAll samples passed at $\ge$ 3.5 secondsPass
    Durability ASTM D-5034$\ge$ 7 lbfAll samples passed at greater than 7 lbfPass
    Tensile Strength ASTM D-5034 Machine Direction and Cross Direction$\ge$ 7 lbfAll samples passed at greater than 7 lbfPass
    Trap Tear ASTM D5587-15 Machine Direction and Cross Direction$\ge$ 2.3 lbfAll samples passed at $\ge$ 2.3 lbfPass
    Water Resistance Impact Penetration Test AATCC 42$\le$ 1.0 gAll samples passed at $\le$ 1.0 gPass
    ASTM D1683 Seam Strength$\ge$ 7 lbfAll samples passed at $\ge$ 7 lbfPass
    ASTM F1671 Viral PenetrationLevel 4: No penetration at 2 psiAll samples showed no penetration at 2 psiPass
    Ethylene oxide residuals ISO 10993-7EO
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