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510(k) Data Aggregation

    K Number
    K161074
    Device Name
    Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2016-11-17

    (213 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHEN WEI (USA), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder-Free Nitrile Examination Glove Flock-Lined, Black Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.
    Device Description
    Powder Free Nitrile Examination Gloves Flock-Lined, Black Color Non-Sterile, is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. The gloves are lined with cotton flock, ambidextrous with beaded cuff, black colored, single use disposable devices that comes is six sizes (XS, S, M, L, and XL) supplied in non-sterile state. The gloves are made of synthetic rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical and performance characteristics meet all requirements of ASTM D6319-10. Powder was not used for this glove's manufacturing process.
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    K Number
    K121811
    Device Name
    POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2012-11-21

    (154 days)

    Product Code
    LZC
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHEN WEI (USA), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K121528
    Device Name
    POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2012-09-11

    (111 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHEN WEI (USA), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.
    Device Description
    The Powder-Free Blue Nitrile Examination Gloves Peppermint Scented meets all requirements of ASTM D 6319-10 and FDA 21 CFR 800.20. The device is made out of nitrile.
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    K Number
    K120890
    Device Name
    POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2012-08-17

    (147 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHEN WEI (USA), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.
    Device Description
    The Powder-Free Nitrile Examination Gloves, Orange is substantial equivalent to Powder-Free Nitrile Examination Gloves, Black Color with 510k number K090194 that is currently marketed. The device modification is a change in color from Black to Orange. Another device modification is the addition of adding a citric acid coating to the interior surface of the gloves to achieve a pH of 5.0 - 5.5 for the inner surface of the glove.
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    K Number
    K113233
    Device Name
    POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2012-03-29

    (148 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHEN WEI (USA), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powdered surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. A powder-free surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    The Surgical Glove is made of all natural rubber, sterile, and powdered with USP absorbable dusting powder and contains less than 50 micrograms or less of protein content.
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    K Number
    K101436
    Device Name
    PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2010-11-17

    (177 days)

    Product Code
    LZC, 80L, LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHEN WEI (USA), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows (Fluorouracil, Etoposide, Cyclophosphamide, Carmustine, Thio-Tepa, Paclitaxel, Doxorubicin Hydrochloride, Dacarbazine, Cisplatin)
    Device Description
    Blue and Red with Pearlescent® Pigment. Powder Free Nitrile Examination Gloves with Aloe Vera, Tested for use with Chemotherapy Drugs meets all the requirements of ASTM D 6978-05, ASTM D6319-00a(2005) and FDA 21 CFT 880.6250.
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    K Number
    K100211
    Device Name
    PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2010-05-11

    (106 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHEN WEI (USA), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. The device is single use only.
    Device Description
    The Pearlescent Black Textured Powder- Free Latex Examination Gloves, Coated with Aloe Vera at pH 5.0-5.5, with (Protein Content Labeling Claim) Contains 50 micrograms or less of Total Water Extractable Protein per gram which had been submitted and cleared under 510(k) number K013793. The difference in this submission is: a) Change of color to be Pearlescent Black.
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    K Number
    K092411
    Device Name
    PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2009-10-21

    (75 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHEN WEI (USA), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.
    Device Description
    Yellow, Red, Green, Black, Blue with Pearlescent™ Pigment, Powder-Free Nitrile Examination Gloves with Aloe Vera
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    K Number
    K090194
    Device Name
    POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2009-07-07

    (161 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHEN WEI (USA), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is for over-the counter use.
    Device Description
    Powder-Free Nitrile Examination Gloves, Black
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    K Number
    K061756
    Device Name
    TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP
    Manufacturer
    SHEN WEI (USA), INC.
    Date Cleared
    2007-04-19

    (302 days)

    Product Code
    LZA, LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHEN WEI (USA), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250) This device is not intended to be used as a chemical barrier.
    Device Description
    Textured Powder Free Nitrile Examination Gloves (Blue color) with SAP (Super Absorbent Polymer), Textured Powder Free Latex Examination (Natural color) with SAP (Super Absorbent Polymer)
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