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510(k) Data Aggregation

    K Number
    K212273
    Device Name
    Cross Protection ResQ300 Plus Surgical Face Mask
    Manufacturer
    Cross Protection (M) Sdn Bhd
    Date Cleared
    2022-08-17

    (393 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K051291
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Cross Protection ResQ300 Plus Surgical Face Masks are intended to be used as isolation face mask and dental face mask.

    Cross Protection ResQ300 Plus Surgical Face Masks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transms, bodily fluids and particulate material.

    Device Description

    The Cross Protection® ResQ300 Plus Surgical Facemask is a pleated, multi-ply design, which is a nonsterile, single use, disposable device. The mask covers the nose and mouth and is secured to the face using the attached ear loops or attached ties.

    The outer layer is made of 100% blue spun-bond polypropylene. The middle layer is filter media composed of 100% white melt-blown polypropylene. The inner (patient contacting) layer is made of either 100% white spun-bond polypropylene or 100% white medical grade tissue paper.

    The ear attachments are either Ear Loop style. Ear Loops are made of elastic and the Tie-On straps are made of 100% white spun-bond polypropylene.

    The nosepiece is made of malleable aluminum.

    All materials used in the construction of the mask are being used in currently marketed devices.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Cross Protection ResQ300 Plus Surgical Face Mask, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Standard)Reported Device Performance (Result)Met Criteria?
    Biocompatibility:
    Cytotoxicity (ISO 10993-5): 0 – None, 1 – Slight, 2 – MildNot cytotoxic – Mild reactivityYes
    Primary Skin Irritation (ISO 10993-10): Negligible: 0 to 0.4Negligible irritantYes
    Sensitization (ISO 10993-10): 0 – No visible changeNon-sensitizingYes
    Performance Testing (ASTM F2100 Level 1):
    Bacterial Filtration Efficiency (BFE) (ASTM F2101-19): ≥ 95%Level 1Yes (≥ 95%)
    Differential Pressure (Delta P) (EN14683):
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