BEUDAMED
    Product Code: KGQ FDA class 1 21 CFR 878.4470

    Cream, Gloving, Surgeon'S

    General, Plastic Surgery

    Surgeon's Gloving Cream is a hand preparation product applied before donning surgical gloves to facilitate smooth and easy donning while maintaining skin condition, used in surgical settings as a practical adjunct to sterile gloving procedures. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KGQ, regulated under 21 CFR 878.4470, within the General, Plastic Surgery medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    KGQ
    Device Class
    FDA class 1
    Regulation Number
    878.4470
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    HO
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K910687 GUARDIAN GEL, SURGEON'S GLOVING CREAM

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.