LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K233183
    Device Name
    Surgical Gown (40083)
    Manufacturer
    Ammex-Weida (Hubei) Health and Safety Products Co., Ltd
    Date Cleared
    2024-02-01

    (126 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K231510
    Why did this record match?
    Device Name :

    Surgical Gown (40083)

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

    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 material. This surgical gown meets the requrements of AAMI Level 3 barrier protection for a surgical gown per ANSI/A AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices, provided sterile.

    Device Description

    The proposed device Surgical Gown is model 40083, its body, sleeve and belt are made of SSMMS non-woven material, and cuff is made of cotton. The proposed device is available in XS, S, M, L, XL, 2XL, 3XL sizes. 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 blue color.

    AI/ML Overview

    This document is a 510(k) Premarket Notification from the FDA regarding a Surgical Gown. It evaluates the device's substantial equivalence to a legally marketed predicate device. The information provided is primarily focused on the physical and barrier performance characteristics of the surgical gown, not an AI/Software as a Medical Device (SaMD) product.

    Therefore, most of the requested information regarding AI/SaMD performance criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone algorithm performance," and "training set details," is not applicable to this submission.

    However, I can extract the relevant information regarding the surgical gown's acceptance criteria and the studies proving it meets those criteria:

    Device: Surgical Gown (Model 40083)
    Intended Use: To be worn by operating room personnel during surgical procedures to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. It meets AAMI Level 3 barrier protection.

    Acceptance Criteria and Reported Device Performance:

    Test ItemTest StandardAcceptance CriteriaReported Device Performance (Result)
    Seam StrengthASTM D1683M-17≥30N (7lbf) per standard F2407-20 for Level 3PASS: 68.46 N (Average result from 30 samples)
    Breaking StrengthASTM D5034-09 (2017)≥30N (7lbf) per standard F2407-20 for Level 3PASS: MD: 120.61N, CD: 88.19N (Average result from 30 samples)
    Tear Strength (N)ASTM D5587-15≥20NPASS: MD: 60.03N, CD: 39.78N (Average result from 30 samples)
    Lint and other generation in the dry stateISO 9073-10:2003(E)Log10(particle count)
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1