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510(k) Data Aggregation

    K Number
    K211762
    Device Name
    Altor Safety 4-Ply Surgical Mask (Model:62232)
    Manufacturer
    Altor Safety LLC
    Date Cleared
    2021-09-03

    (87 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K192374
    Predicate For
    K221209
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Altor Safety 4-Ply Surgical Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Altor Safety 4-Ply Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non- sterile, disposable device.

    Device Description

    The Altor Safety 4-Ply Surgical Mask is a flat-pleated mask with ear loops and nose piece for fitting and securing the mask to the to the user's face. The mask outward facing layer is blue in color, using color master batch. The device is manufactured with 4 layers: 2-Outer Facing Layers: Spunbond nonwoven polypropylene (Blue), Middle Layer: Melt Blown nonwoven polypropylene (White) and Inner Layer: Spunbond nonwoven polypropylene (White). Other Materials used include the Ear loops which are made from Spandex / Nylon. The subject device is provided non-sterile and is a single use, disposable device.

    AI/ML Overview

    This document is a 510(k) summary for a surgical mask (Altor Safety 4-Ply Surgical Mask, Model: 62232). It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing rather than a study involving human or AI performance. Therefore, many of the requested elements for a study proving a device meets acceptance criteria, particularly for AI/human reader performance, are not applicable to this document.

    However, I can extract the acceptance criteria (pass criteria) and reported device performance for the physical and biological characteristics of the surgical mask, as detailed in the non-clinical performance testing section.

    Here's a breakdown of the requested information based solely on the provided document:

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

    Test MethodPurposeAcceptance Criteria (Pass Criteria)Reported Device Performance (Results)
    ASTM F2101-19 (Bacterial Filtration Efficiency - BFE)Evaluate Bacterial filtration efficiency (%)≥98%3 lots tested with total 96 samples, 94/96 Passed at ≥98% /Pass (Note: Listed as 99.60% in Table 1)
    EN 14683: 2019, Annex C (Differential Pressure - Delta-P)Evaluate Differential pressure (Delta-P)
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