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510(k) Data Aggregation

    K Number
    K221717
    Device Name
    Disposable Surgical Gown UM-148
    Manufacturer
    Unimax Medical Products Co., Ltd.
    Date Cleared
    2022-09-20

    (99 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K212591
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.

    Device Description

    The proposed device Disposable Surgical Gown is model UM-148, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of polyester. The proposed device is available in sizes: S(120×135cm), M(125×140cm), L(130×145cm) and XL(135×150cm). This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012. The proposed devices are disposable medical devices and provided in sterile and a blue color.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device, specifically a "Disposable Surgical Gown (UM-148)". This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study" described are about showing that the new surgical gown performs comparably to established standards and a predicate device, rather than proving a new clinical claim.

    Here's an analysis of the provided information, formatted as requested:

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

    Acceptance Criteria / Standard (Ref.)Reported Device Performance
    AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended For Use In Health Care Facilities. Level 3: When tested for water resistance in accordance with AATCC 42 (impact penetration) and AATCC 127 (hydrostatic pressure) and all critical zone components shall have a blotter weight gain of no more than 1.0 g and a hydrostatic pressure of >50 cm.Level 3 (The device meets Level 3 requirements for Liquid Barrier Performance and Classification)
    ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure: ≥10 NPASS
    MD: 45.5N
    CD: 28.2N (Average result from 10 samples)
    ASTM D5034-09 (2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test): ≥30NPASS
    MD: 145.4N
    CD: 91.4N (Average result from 10 samples)
    ASTM D1683M-17 Standard Test Method for Failure in Sewn Seams of Woven Fabrics: ≥30NPASS
    52.6N (Average result from 10 samples)
    AATCC 42-2013, Water Penetration Resistance: Impact Penetration Test: ≤1.0 gPASS
    0 g (Average result from 3 nonconsecutive batches)
    Evaporative Resistance ASTM F1868-17: 50 cmPASS
    65~72 cm (Average result from 3 nonconsecutive batches)
    CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles: Meets Class I requirementsPASS
    Class I (Average result from 5 samples)
    **ISO 9073- 10:2003(E) Lint and Other Particles Generation: Log10(particle count)
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