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510(k) Data Aggregation

    K Number
    K213141
    Device Name
    Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
    Manufacturer
    Shen Wei USA Inc.
    Date Cleared
    2022-05-28

    (243 days)

    Product Code
    LZA, LZC, QDO
    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
    Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
    Device Description
    Not Found
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    K Number
    K213142
    Device Name
    Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution
    Manufacturer
    Shen Wei USA Inc.
    Date Cleared
    2022-01-28

    (123 days)

    Product Code
    LZA, LZC, QDO
    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
    Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
    Ask a Question
    K Number
    K213144
    Device Name
    Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
    Manufacturer
    Shen Wei USA Inc.
    Date Cleared
    2021-12-22

    (86 days)

    Product Code
    LYZ
    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
    Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors are disposable devices intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
    Ask a Question
    K Number
    K211620
    Device Name
    Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)
    Manufacturer
    Shen Wei USA Inc.
    Date Cleared
    2021-08-19

    (85 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
    Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)
    Device Description
    Not Found
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    K Number
    K211455
    Device Name
    Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors
    Manufacturer
    Shen Wei USA Inc.
    Date Cleared
    2021-07-28

    (79 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 Gloves with Aloe Vera, Orange and Orange-White Colors
    Device Description
    Not Found
    Ask a Question
    K Number
    K202085
    Device Name
    Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green
    Manufacturer
    Shen Wei USA Inc.
    Date Cleared
    2021-06-21

    (329 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.
    Device Description
    Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green
    Ask a Question
    K Number
    K202083
    Device Name
    Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
    Manufacturer
    Shen Wei USA Inc.
    Date Cleared
    2021-03-25

    (241 days)

    Product Code
    LZA, 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
    Indications for Use (Describe) CAUTION: Testing showed an average breakthrough time of 39.1 minutes for Thiotepa. WARNING: Do not use with Carmustine.
    Device Description
    Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
    Ask a Question
    K Number
    K202080
    Device Name
    Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color
    Manufacturer
    Shen Wei USA Inc.
    Date Cleared
    2021-03-24

    (240 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
    Not Found
    Device Description
    Not Found
    Ask a Question
    K Number
    K202081
    Device Name
    Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue
    Manufacturer
    Shen Wei USA Inc.
    Date Cleared
    2021-03-19

    (235 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
    Not Found
    Device Description
    Not Found
    Ask a Question
    K Number
    K202082
    Device Name
    Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid
    Manufacturer
    Shen Wei USA Inc.
    Date Cleared
    2021-03-17

    (233 days)

    Product Code
    LZA, LZC, ODO
    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
    Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid
    Device Description
    Not Found
    Ask a Question

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