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510(k) Data Aggregation

    K Number
    K061375
    Device Name
    RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730
    Manufacturer
    LOUIS M. GERSON CO., INC.
    Date Cleared
    2006-11-17

    (184 days)

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

    LOUIS M. GERSON CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gerson 1730 N95 Particulate Respirator is intended to be worn by operating room personnel during healthcare procedures to protect both the patient and healthcare professionals from the transfer of microorganisms, bodily fluids and particulate material. This device also meets CDC guidelines for TB exposure. Subject device is also a surgical mask and is single use / disposable.
    Device Description
    The 1730 N95 Particulate Respirator and Surgical Mask is constructed from a white nonwoven material used for the inner and outer shell. The polypropylene meltblown filter media is layered between the inner and outer shell. The headband is made of elastic and welded to the mask. The inside nosepiece is made of an open celled foam and the outside nosepiece, which conforms to the nose, is made of aluminum. The 1730 N95 Particulate Respirator is approved by NIOSH as per 42 CFR 84. The certification number assigned is TC-84A-160 for a type N95 Particulate Respirator. The N95 must meet the prescribed test criteria of a 0.3 micron diameter challenge and requiring a 95% efficiency. This mask is also fluid resistant as per the ASTM D583-65 Method 1 and is resistant to synthetic blood as per protocol number 9602202-01 conducted by Nelson Laboratories. Breathing resistance was tested as per 42 CFR 84.
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    K Number
    K050193
    Device Name
    GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR
    Manufacturer
    LOUIS M. GERSON CO., INC.
    Date Cleared
    2005-04-11

    (74 days)

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

    LOUIS M. GERSON CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gerson Model 2130 /2131 Disposable Surgical N95 Particulate Respirators are intended to be worn by operating room personnel during surgical procedures to protect the wearer from transfer of both the surgical patient and particulate material. The respirator is a single-use disposable. The 2130 and 2131 Model respirators are available in either blue or white colors. This device also meets CDC Guidelines for TB Exposure Control.
    Device Description
    Not Found
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    K Number
    K960778
    Device Name
    ISOLAIR APR TYPE N95
    Manufacturer
    LOUIS M. GERSON CO., INC.
    Date Cleared
    1996-05-09

    (73 days)

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

    LOUIS M. GERSON CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. This device also meets CDC Guidelines for "B Exposure Control.
    Device Description
    The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is constructed from a white nonwoven material used in the inner and outer shell. The polypropylene melt blown filter media is layered between the inner and outer shell. The headband is made of rubber stapled to the mask. The inside nosepiece utilizes a closed cell foam and the outside nosepiece which conforms to the nose is made of aluminum. The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is approved by NIOSH as per 42 CFR 84. The certification number assigned is TC-84A-160 for a type N95 Particulate Respirator. The Type N95 must meet the prescribed test criteria which specifies the use of 0.3 micron diameter challenge and requiring a 95% efficiency. This mask is also fluid resistant as per (ASTM D583 65 Method) and is resistant to synthetic blood as per Protocol number 9602202-01 conducted by Nelson Laboratories. Breathing resistance was tested as per NIOSH 30 CFR11 section 11.140-9.
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