Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K243342

    Validate with FDA (Live)

    Date Cleared
    2025-12-22

    (423 days)

    Product Code
    Regulation Number
    878.4040
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KP Protective Face Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material.

    Device Description

    The KP Protective Face Mask is a non-sterile, single-use surgical mask intended to cover the user's nose and mouth, providing a physical barrier to fluids, microorganisms, and particulate matter.

    The mask consists of three nonwoven polypropylene layers, including:

    • Outer layer: Spunbond non-woven
    • Filter layer: Melt-blown polypropylene
    • Inner comfort layer: Spunbond non-woven
    • Nose wire: Polypropylene-clad adjustable wire
    • Attachment: Elastic earloops (A mixture of nylon and polyurethane)

    The mask is white, flat-fold style, supplied non-sterile, and packaged in standard pouches.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1