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510(k) Data Aggregation

    K Number
    K091097
    Device Name
    PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501
    Manufacturer
    PROMEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2009-05-27

    (41 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROMEDICAL PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K080629
    Device Name
    PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS
    Manufacturer
    PROMEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2008-10-20

    (229 days)

    Product Code
    KKX, MMP
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROMEDICAL PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    proMedical Products Co. LTD intends to market sterile surgical drapes identified in 21 CFR 878.4370 as device made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. proMedical Products Co. LTD intends to market Sterile surgical equipment covers which are protective barrier covers that are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.
    Device Description
    Not Found
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    K Number
    K080627
    Device Name
    PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A
    Manufacturer
    PROMEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2008-04-24

    (50 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROMEDICAL PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    proMedical Surgical gowns are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of micro-organisms, body fluids, and particulate matter.
    Device Description
    proMedical Surgical Gowns are disposable, single use, sterile surgical gowns manufactured from non-woven spunbond-meltblown-spunbond polypropylene or spun-laced fabrics. Gowns are provided as listed below. | No. | Model<br>Number | Name | Size | Category | |-----|-----------------|---------------------------------------------|-------------------------------------|------------| | 1 | 18-001 | OR Spunlace Gown, Standard | Medium, Large, X-large,<br>XX-Large | Standard | | 2 | 18-101 | OR Spunlace Gown, with Fabric Reinforcement | Medium, Large, X-large,<br>XX-Large | Reinforced | | 3 | 18-201 | OR Spunlace Gown, with Poly Reinforcement | Medium, Large, X-large,<br>XX-Large | Reinforced | | 4 | 18-301 | OR SMS Gown, Standard | Medium, Large, X-large,<br>XX-Large | Standard | | 5 | 18-401 | OR SMS Gown, with Fabric Reinforcement | Medium, Large, X-large,<br>XX-Large | Reinforced | | 6 | 18-501 | OR SMS Gown, with Poly Reinforcement | Medium, Large, X-large,<br>XX-Large | Reinforced |
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    K Number
    K042111
    Device Name
    PROMEDICAL SURGICAL GOWNS
    Manufacturer
    PROMEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2004-12-10

    (127 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROMEDICAL PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    proMedical Products Co. LTD intends to market Non-sterile surgical gowns identified in 21 CFR 878.4040 as medical devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from the transfer of microorganisms, bodily fluids and particulate material.
    Device Description
    Surgical Gowns
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    K Number
    K042131
    Device Name
    PROMEDICAL SURGICAL DRAPES
    Manufacturer
    PROMEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2004-12-10

    (123 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROMEDICAL PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    proMedical Products Co. LTD intends to market Non-sterile surgical drapes identified in 21 CFR 878.4370 as device made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination
    Device Description
    Non-sterile Disposable Surgical Drapes made of natural or synthetic material.
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    K Number
    K042137
    Device Name
    PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS
    Manufacturer
    PROMEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2004-10-05

    (57 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROMEDICAL PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    proMedical Products Co. Ltd. intends to market Non-sterile surgical equipment covers which are protective barrier covers that are intended to cover equipment and provide a protective barrier for that equipment.
    Device Description
    Non-sterile surgical equipment covers which are protective barrier covers that are intended to cover equipment and provide a protective barrier for that equipment.
    Ask a Question

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