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510(k) Data Aggregation

    K Number
    K211425
    Device Name
    Private Stock Labs Surgical Face Mask
    Manufacturer
    J.K. Private Stock Inc.
    Date Cleared
    2021-10-04

    (150 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K182515
    Why did this record match?
    Device Name :

    Private Stock Labs Surgical Face Mask

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

    The Private Stock Labs Surgical Face Mask is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. Private Stock Labs Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

    Device Description

    PRIVATE STOCK LABS Surgical Face Mask is a single use, three-layer, flat-pleated mask with ear loops and a nose piece. The Surgical Face Mask is manufactured with three layers, of which the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with latex materials, but are made of spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of malleable polyethylene wire. The surgical mask will be provided in green of outside and white of inside. PRIVATE STOCK LABS Surgical Face Mask is provided non-sterile and for single use.

    AI/ML Overview

    This document describes the non-clinical testing performed for the Private Stock Labs Surgical Face Mask (K211425) to demonstrate substantial equivalence to a predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Test MethodologyPurposeAcceptance CriteriaReported Device Performance (Result for 3 Lots)
    Fluid Resistance ASTM F1862Evaluate Personal Protective Equipment against fluid penetration, simulating arterial spray.29 out of 32 pass at 120mmHgLot 1: 32 out of 32 pass at 120mmHg
    Lot 2: 32 out of 32 pass at 120mmHg
    Lot 3: 32 out of 32 pass at 120mmHg
    Particulate Filtration Efficiency ASTM F2299Evaluate the non-viable particle filtration efficiency.≥ 98%Lot 1: 99.9% (32 out of 32 pass)
    Lot 2: 99.9% (32 out of 32 pass)
    Lot 3: 99.9% (32 out of 32 pass)
    Bacterial Filtration Efficiency ASTM F2101Determine the bacterial filtration efficiency.≥98%Lot 1: 99.9%
    Lot 2: 99.9%
    Lot 3: 99.9%
    Differential Pressure (Delta-P) MIL-M-36954CEnsure the pressure drop is not too great for user breathing.
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