BEUDAMED
    FDA Registration Active 🇺🇸 United States

    JOFRI-GELSS, Gloves examination, latex, sterile, ambidextrous, disposable. Small size

    Reg #: 3010830834 · FEI: 3004525092 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    BiometerPlus USA, Inc.
    Registration Number
    3010830834
    FEI Number
    3004525092
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    48531 Warm Springs Blvd., #416
    City
    Fremont
    State
    CA
    ZIP
    94539
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171782

    Owner / Operator

    Firm Name
    BiometerPlus USA, Inc.
    Operator Number
    10046647
    Address
    48531 Warm Springs Blvd., #416
    City
    Fremont
    State
    CA
    Postal Code
    94539
    Country
    US
    Correspondent
    Jian Zhou

    Products

    Device Name Product Code
    Medical Glove, Specialty LZC
    Polymer Patient Examination Glove LZA

    Proprietary Names

    JOFRI-GELSS, Gloves examination, latex, sterile, ambidextrous, disposable. Small size JOFRI-GEPMS, Gloves examintaion, polyethylene, sterile, ambidextrous, disposabe. Medum size JOFRI-GSL700S, Gloves surgery latex, sterile, and disposable. Size 7, pair JOFRI-GSL800S, Gloves surgery latex, sterile, and disposable. Size 8, pair JOFRI-GELLS, Gloves examination, latex, sterile, ambidextrous, disposable. Large size JOFRI-GELLS, Gloves examination, latex, none sterile, ambidextrous, disposable. Large size JOFRI-GEPLS, Gloves examintaion, polyethylene, sterile, ambidextrous, disposabe. Large size JOFRI-GELSNS, Gloves examination, latex, non sterile, ambidextrous, disposable. Small size JOFRI-GELMNS, Gloves examination, latex, non sterile, ambidextrous, disposable. Medium size JOFRI-GELMS, Gloves examination, latex, sterile, ambidextrous, disposable. Medium size JOFRI-GSL612S, Gloves surgery latex, sterile and disposable. Size 6 1/2, pair JOFRI-GSL812S, Gloves surgery latex, sterile, and disposable. Size 8 1/2, pair JOFRI-GSL712S, Gloves surgery latex, sterile, and disposable. Size 7 1/2, pair

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility