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510(k) Data Aggregation

    K Number
    K211260
    Device Name
    Sheng Jing Tang Surgical Mask
    Manufacturer
    Liaoning Shengjingtang Biotechnology Co., Ltd.
    Date Cleared
    2022-01-10

    (259 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K200847
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Sheng Jing Tang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. Adult only. The device is disposable and is indicated for single use. The device is not provided sterile.

    Device Description

    The Sheng Jing Tang Surgical Masks are composed of 3-layers and are flat-pleated provided blue color, the mask materials consist of an outer layer (Spun-bond polypropylene), Inner layer (Spun-bond polypropylene), Middle Layer filter (Polypropylene Melt-blown Cloth), Ear-loops (Spandex + Nylon, Ear Loops way for wearing) and Nose piece (a Polyethylene + Galvanized Iron wire nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face). The Sheng Jing Tang Surgical Masks are single use, disposable device, adult only, provided non-sterile.

    AI/ML Overview

    This document describes the premarket notification (510(k)) for the Sheng Jing Tang Surgical Mask. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the non-clinical performance and biocompatibility testing conducted to demonstrate substantial equivalence to a predicate device.

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

    1. Table of Acceptance Criteria and Reported Device Performance

    This information is primarily found in Section 7.1 "Performance Test" and Section 7.2 "Biocompatibility Evaluation and Test" of the 510(k) Summary.

    Performance Test (Bench Tests)

    Performance TestAcceptance CriteriaReported Device Performance (Sheng Jing Tang Surgical Mask)Result
    Fluid Resistance (ASTM F1862-17)≥ 29 of 32 pass at 120 mmHgPass (96/96) from 3 non-consecutive lots: Lot 1: 32/32 pass at 120 mmHg; Lot 2: 32/32 pass at 120 mmHg; Lot 3: 32/32 pass at 120 mmHgPassed
    Particulate Filtration Efficiency (ASTM F2299-17)≥ 98%Pass (96/96) from 3 non-consecutive lots: Lot 1: ≥ 98.24%; Lot 2: ≥ 98.78%; Lot 3: ≥ 98.82%Passed
    Bacterial Filtration Efficiency (ASTM F2101-19)≥ 98%Pass (96/96) from 3 non-consecutive lots: Lot 1: ≥ 99.9%; Lot 2: ≥ 99.9%; Lot 3: ≥ 99.9%Passed
    Differential Pressure (EN 14683:2019, Annex C & ASTM F2100-20)
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