BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM

    K Number: K030331 · Decision Mar 21, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    30
    Review Days
    49

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM
    K Number
    K030331
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Perusahaan Getah Asas Sdn. Bhd.
    Date Received
    January 31, 2003
    Decision Date
    March 21, 2003
    Product Code
    LYY
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LYY Latex Patient Examination Glove

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LYY), ordered by most recent decision date.

    Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Latex Examination Glove Powder Free (Ocean Blue and Natural White)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Powder-Free Latex examination gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Non Sterile Powder Free Latex Examination Glove

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all

    Other Clearances by Perusahaan Getah Asas Sdn. Bhd.

    K Number Device Name
    K102790 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG
    K042805 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE
    K032374 POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
    K031625 POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED
    K031768 BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED
    K031414 POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE
    K031591 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED
    K031021 CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
    K030333 LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM
    K030335 ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED
    Search all 30 clearances from Perusahaan Getah Asas Sdn. Bhd. →