BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TP AND DESIGN, CONDOM

    K Number: K902324 · Decision Mar 29, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    400
    Applicant Total
    12
    Review Days
    309

    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
    TP AND DESIGN, CONDOM
    K Number
    K902324
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    China National Medicines & Health Prod. I/E Corp.
    Date Received
    May 24, 1990
    Decision Date
    March 29, 1991
    Product Code
    HIS
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIS Condom

    Similar 510(k) Clearances

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

    Male Latex Condom HA

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LifeStyles® HydraFeel Natural Rubber Latex Condom

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Natural rubber latex male condom

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Lelo Hex Lubricated Natural Rubber Latex Condom

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    0.04 ZERO ZERO FOUR Male Latex Condom

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by China National Medicines & Health Prod. I/E Corp.

    K Number Device Name
    K893351 LATEX EXAMINATION GLOVES (MFG. ANHUI BENGBU LATEX)
    K892916 PATIENT EXAMINATION GLOVES (LATEX)
    K891365 LATEX EXAMINATION GLOVES, NON-STERILE
    K870306 WHITE PLUME TRIANGULAR BANDAGE
    K870309 WHITE PLUME ABSORBENT COTTON WOOL
    K870312 WHITE PLUME SURGICAL GAUZE FACE MASK
    K870308 WHITE PLUME ABSORBENT GAUZE
    K870315 WHITE PLUME ABSORBENT BANDAGE
    K870314 WHITE PLUME GAUZE SPONGE
    K870310 VSID MEDICAL THREE-FOLDING BED
    Search all 12 clearances from China National Medicines & Health Prod. I/E Corp. →