LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K212330
    Device Name
    Yadu Medical Face Mask (Level 1)
    Manufacturer
    HeNan YADU Industrial Co., Ltd.
    Date Cleared
    2022-03-14

    (230 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K212120
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Y ADU Surgical Masks (Model E (ear loops, sterile), Model T (tie on straps, sterile/non-sterile/) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended to be used in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided sterile and non sterile.

    Device Description

    The YADU Surgical Masks are single use, three-layer, flat-pleated style with ear loops and nose piece. They have three layers structure: inner layer, and outer layer. The inner and outer layers are made of spun-bond polypropylene (SPP), and the middle layer is made of melt blown polypropylene filter. Y ADU Surgical Masks have two variants: The model with ear loop and the model with tie-on bands. The mask is held in place over the users' mouth and nose by two elastic ear loops or tie-on bands welded to the side of the mask. The ear loops are made from spandex and polyester elastic, while tie-on bands are made from SPP straps. Neither elastic ear loops nor tie-on bands are made with natural rubber latex. Y ADU Surgical Masks also have nose piece that allows the user to fit the mask around his/her nose. The nose piece is made of polyvinyl chloride coated iron wire. The Surgical Masks provide Level-1 protection per ASTM F2100 definition. They have blue color and are sold in both sterile and non-sterile versions and are intended to be single use, disposable devices.

    AI/ML Overview

    This document is a 510(k) Pre-Market Notification for YADU Surgical Masks, demonstrating its substantial equivalence to a legally marketed predicate device. The information provided focuses on the technical performance of the surgical masks rather than an AI/ML powered device. Therefore, a direct mapping to the requested information about an AI/ML device is not fully applicable. However, I will extract relevant information from the provided text that corresponds to the structure of your request, interpreting "device" as the surgical mask in this context.

    Here's an analysis of the provided text based on your request:

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

    Test NameAcceptance CriteriaReported Performance (YADU Surgical Masks)
    ASTM F2101-19 Bacterial Filtration Efficiency (BFE) (Sterile)≥ 95%Lot 1: 95.1-97.4%, Lot 2: 95.1-98.4%, Lot 3: 95.1-98.4%
    ASTM F2299-03 Penetration by Particulates (Sterile)≥ 95%Lot 1: 95.1-97.9%, Lot 2: 95.1-99.6%, Lot 3: 95.1-97.4%
    EN 14683-2019 Differential Pressure (Sterile)
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1