Search Filters

Search Results

Found 18 results

510(k) Data Aggregation

    K Number
    K032016
    Device Name
    DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT
    Manufacturer
    WRP SPECIALTY PRODUCTS SDN. BHD.
    Date Cleared
    2004-05-11

    (316 days)

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

    WRP SPECIALTY PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The patient examination glove is a disposable device and is made of natural The patient exammation grove is a 'displace' worn on the examiner's hand of furoer to prevent contamination between patient and examiner.
    Device Description
    The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578 - 01aE2 and FDA 21 CFR 800.20.
    Ask a Question
    K Number
    K022808
    Device Name
    DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)
    Manufacturer
    WRP SPECIALTY PRODUCTS SDN. BHD.
    Date Cleared
    2002-10-03

    (41 days)

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

    WRP SPECIALTY PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578 -- 01a"22 and FDA 21.CFR 800.20.
    Ask a Question
    K Number
    K021561
    Device Name
    DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM O
    Manufacturer
    WRP SPECIALTY PRODUCTS SDN. BHD.
    Date Cleared
    2002-06-11

    (29 days)

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

    WRP SPECIALTY PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01ε1 and FDA 21 CFR 800.20.
    Ask a Question
    K Number
    K021536
    Device Name
    DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR
    Manufacturer
    WRP SPECIALTY PRODUCTS SDN. BHD.
    Date Cleared
    2002-06-10

    (31 days)

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

    WRP SPECIALTY PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The patient examination glove may also provides additional protection in other areas where users are handling certain hazardous chemical such as commonly used chemotherapy drugs, as penetration and permeation by these drugs are resisted.
    Device Description
    The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Microgram or less) and Tested for Use with Chemotherapy Drugs meets all the requirements of ASTM standard D 3578 - 0151 and FDA 21 CFR 800.20.
    Ask a Question
    K Number
    K021396
    Device Name
    DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE
    Manufacturer
    WRP SPECIALTY PRODUCTS SDN. BHD.
    Date Cleared
    2002-05-16

    (14 days)

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

    WRP SPECIALTY PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    The Powder Free Purple Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00af1 and FDA 21 CFR 800.20.
    Ask a Question
    K Number
    K014288
    Device Name
    DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS
    Manufacturer
    WRP SPECIALTY PRODUCTS SDN. BHD.
    Date Cleared
    2002-02-13

    (47 days)

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

    WRP SPECIALTY PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) is a disposable device intended for medical purposes that is worn by surgeon's and / or operating room personnel to protect a surgical wound from contamination.
    Device Description
    The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) meets all the requirements of ASTM Standard D 3577 - 00 and FDA 21 CFR 800.20.
    Ask a Question
    K Number
    K013942
    Device Name
    POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING)
    Manufacturer
    WRP SPECIALTY PRODUCTS SDN. BHD.
    Date Cleared
    2001-12-31

    (32 days)

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

    WRP SPECIALTY PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    The Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01 Type I and FDA 21 CFR 800.20.
    Ask a Question
    K Number
    K012876
    Device Name
    DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    Manufacturer
    WRP SPECIALTY PRODUCTS SDN. BHD.
    Date Cleared
    2001-10-01

    (35 days)

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

    WRP SPECIALTY PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Powder Free Latex Examination Gloves with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    The Powder Free Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile meets all the requirements of ASTM Standard D 3578 - 00 and FDA 21 CFR 800.20.
    Ask a Question
    K Number
    K003307
    Device Name
    DERMAGRIP POWDER FREE PINK POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL W
    Manufacturer
    WRP SPECIALTY PRODUCTS SDN. BHD.
    Date Cleared
    2000-11-22

    (30 days)

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

    WRP SPECIALTY PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K003309
    Device Name
    DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE
    Manufacturer
    WRP SPECIALTY PRODUCTS SDN. BHD.
    Date Cleared
    2000-11-22

    (30 days)

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

    WRP SPECIALTY PRODUCTS SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 2