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510(k) Data Aggregation

    K Number
    K202255
    Device Name
    Skypro, SP02 Mask (3)
    Manufacturer
    Skypro Medical Supplies Company
    Date Cleared
    2021-12-24

    (501 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K152197
    Why did this record match?
    Device Name :

    Skypro, SP02 Mask (3)

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

    "Skypro, SP02 Mask (Level 3)" is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended for infection control practices to reduce the potential exposure of the wearer to blood and body fluids. It is a non-sterile, single-use, and disposable device.

    Device Description

    "Skypro, SP02 Mask (Level 3)" is a flat-pleated surgical or procedure mask. It is composed of 4-layer spunbond/meltblown polypropylene fabrics, elastic earloops or ties, and a moldable nose clip.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

    Device: Skypro, SP02 Mask (Level 3)
    Product Code: FXX
    Regulation Name: Surgical apparel
    Regulatory Class: Class II

    1. Table of Acceptance Criteria and Reported Device Performance

    Test MethodologyPurposeAcceptance CriteriaReported Device Performance
    Biocompatibility Test:To determine if the mask may cause adverse biological reactions.
    Cytotoxicity Test (MEM Elution)To determine if the mask may cause cytotoxic effects.Non-cytotoxicNon-cytotoxic
    Sensitization Test (Kligman Max)To determine if the mask may cause skin sensitization.Non-sensitizingNon-sensitizing
    Primary Skin Irritation TestTo determine if the mask may cause skin irritation.Non-irritatingNon-irritating
    Fluid Resistance TestTo determine the capability of mask to resist the penetration of fluids.Pass @ 160 mmHgPass
    Particle Filtration EfficiencyTo measure the filtration efficiency of mask for particulates.≥ 98%98.59%
    Bacterial Filtration EfficiencyTo measure the filtration efficiency of mask for bacteria.≥ 98%99.24%
    Differential Pressure (Delta P)To measure how easily air is passed, an indicator of air permeability or breathability.
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