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510(k) Data Aggregation

    K Number
    K993117
    Device Name
    SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG
    Manufacturer
    SAFESKIN CORP.
    Date Cleared
    2000-03-02

    (164 days)

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

    SAFESKIN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical examination glove intended to be worn on the hands of healthcare personnel and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.
    Device Description
    The Safeskin PFE-XTRA Examination Glove is a disposable device intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.
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    K Number
    K994081
    Device Name
    SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES
    Manufacturer
    SAFESKIN CORP.
    Date Cleared
    2000-01-18

    (46 days)

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

    SAFESKIN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A surgeon's glove is intended to be worn on the hands of operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.
    Device Description
    Safeskin Tactylon® PF powder-free surgical gloves are sterile disposable devices intended to be worn by operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure. Safeskin® Tactylon PF powder-free surgical gloves possess the following technological characteristics (as compared to ASTM or equivalent standards): Dimensions Meets ASTM D 3577, Physical Properties Meets ASTM D 3577, Freedom from pinholes Meets ASTM D 3577 Meets ASTM D 5151, Powder-Free Meets ASTM D 6124 2 mg/glove maximum.
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    K Number
    K992830
    Device Name
    SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE
    Manufacturer
    SAFESKIN CORP.
    Date Cleared
    1999-10-27

    (65 days)

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

    SAFESKIN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
    Device Description
    The Safeskin Polymer-Coated Nitrile Examination Glove are sterile disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between personnel and the patient. The Safeskin Polymer-Coated Nitrile Examination Glove possesses the following technological characteristics (as compared to ASTM or equivalent standards): Dimensions Meets ASTM D 3578-99, Physical Properties Meets ASTM D 3578-99, Freedom from pinholes Meets ASTM D 5151, Powder-Free Meets ASTM D 6124 2 mg/glove maximum.
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    K Number
    K992210
    Device Name
    SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES
    Manufacturer
    SAFESKIN CORP.
    Date Cleared
    1999-09-10

    (71 days)

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

    SAFESKIN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
    Device Description
    ShieldMaster Powdered Purple Nitrile Gloves are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
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    K Number
    K992162
    Device Name
    SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM
    Manufacturer
    SAFESKIN CORP.
    Date Cleared
    1999-08-30

    (66 days)

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

    SAFESKIN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.
    Device Description
    Safeskin Purple Nitrile Examination Gloves are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient and for use with chemotherapeutic agents.
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    K Number
    K992062
    Device Name
    SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES
    Manufacturer
    SAFESKIN CORP.
    Date Cleared
    1999-08-25

    (68 days)

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

    SAFESKIN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
    Device Description
    Safeskin Sterile Purple Nitrile Examination Gloves are sterile disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
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    K Number
    K991951
    Device Name
    SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE)
    Manufacturer
    SAFESKIN CORP.
    Date Cleared
    1999-07-26

    (46 days)

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

    SAFESKIN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
    Device Description
    Safeskin Synthetic Powder-Free Examination Gloves are disposable medical gloves intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
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    K Number
    K991317
    Device Name
    POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
    Manufacturer
    SAFESKIN CORP.
    Date Cleared
    1999-05-21

    (32 days)

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

    SAFESKIN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A surgeon's glove is intended to be worn on the hands of operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.
    Device Description
    Safeskin® PFS PLUS powder-free latex surgical gloves are sterile disposable devices intended to be worn by operating room personnel to prevent contamination between such personnel and the patient during a surgical procedure.
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    K Number
    K970899
    Device Name
    SAFESKIN POWDERED EXAMINATION GLOVE
    Manufacturer
    SAFESKIN CORP.
    Date Cleared
    1997-05-06

    (56 days)

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

    SAFESKIN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962139
    Device Name
    SAFESKIN
    Manufacturer
    SAFESKIN CORP.
    Date Cleared
    1996-12-19

    (199 days)

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

    SAFESKIN CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
    Device Description
    This Class I Nitrile patient examination glove (80FMC) is powder-free and meets all the requirements of ASTM Standard D 3578-91 with the exception of pre-aged ultimate elongation. This applicant glove, does however, far exceed the requirements for the only synthetic (non-natural latex) examination glove requirements as described in ASTM D 5250-92. The glove is the same product to which equivalence is claimed, K932404 (Safeskin), except colorant and the Hypoallergenic claim have been added.
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