BEUDAMED
    Product Code: IWP FDA class 1 21 CFR 892.6500

    Radiographic Protective Glove

    Radiology

    A protective radiographic glove is a lead-lined or radiation-attenuating glove worn to protect the operator, patient, or other individuals from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier. These devices are not patient examination gloves or surgeon's gloves but are dedicated personnel protective shields. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IWP, regulated under 21 CFR 892.6500, within the Radiology medical specialty.

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    510(k)s
    5
    FEI Numbers
    61
    Registration Numbers
    61
    Unique Applicants
    4
    Years Active
    7

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    Basic Information

    Product Code
    IWP
    Device Class
    FDA class 1
    Regulation Number
    892.6500
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    4

    Device Characteristics

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

    Definition

    A protective radiographic glove is a "personnel protective shield." The gloves are intended to protect the operator, patient, or other person from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. Note: These devices are not patient examination gloves or surgeon's gloves. -

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 5 510(k) clearances via K numbers.

    K Number Device Name
    K920538 PROTECTIVE RADIOGRAFIC GLOVE
    K904878 SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.
    K905086 HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES
    K900972 RADIATION PROTECTION GLOVES
    K844683 IMAGEN CHLAMYDIA TEST

    FEI Numbers

    This FDA classification entry is associated with 61 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 61 registration numbers. Click on an entry to view related FDA registrations.