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

    CURITY DISPOSABLE LATEX GLOVES

    K Number: K891255 · Decision Apr 13, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    66
    Review Days
    36

    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
    CURITY DISPOSABLE LATEX GLOVES
    K Number
    K891255
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Kendall Healthcare Products Co. Div.Of Tyco Health
    Date Received
    March 8, 1989
    Decision Date
    April 13, 1989
    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 Kendall Healthcare Products Co. Div.Of Tyco Health

    K Number Device Name
    K973763 KENDALL CURITY IODOFORM PACKING STRIP
    K973511 KENDALL CURITY PETROLATUM GAUZE
    K973507 KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
    K973619 KENDALL CURITY NON-ADHERING DRESSING
    K973509 KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
    K973546 KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
    K970266 KENDALL HYDROPHILIC POWDER WOUND DRESSING
    K963446 KENDALL DUAL LUMEN CATHETER
    K964899 KENDALL CURITY URETERAL CATHETER
    K964519 CURITY THORACENTESIS TRAY
    Search all 66 clearances from Kendall Healthcare Products Co. Div.Of Tyco Health →