Search Filters

Search Results

Found 35 results

510(k) Data Aggregation

    K Number
    K233022
    Device Name
    Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small
    Manufacturer
    Owens & Minor (O&M) Halyard, Inc.
    Date Cleared
    2024-01-12

    (112 days)

    Product Code
    MSH
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    MSH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HALYARD* FLUIDSHIELD* N95 Particulate Filter Respirator and Surgical Mask family is intended for use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
    Device Description
    Respirator consisting of nonwoven inner facing, filter media(s), a fluid barrier film, and an outer facing. It covers the nose and mouth of the wearer and is held in place with two synthetic elastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece
    Ask a Question
    K Number
    K172963
    Device Name
    Master-Frank N95 Particulate Respirator
    Manufacturer
    Master & Frank Enterprise Co., Ltd
    Date Cleared
    2018-04-04

    (190 days)

    Product Code
    MSH
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    MSH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N95 Particulate Respirator (MF01) is single-use, disposable device, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Device Description
    The N95 particulate respirator (Model MF-01) is NIOSH certified (TC-84A-7697), pouched-shaped respirators when worn. The flat-folded respirator is composed of four layers-inner layer, filter (2 layers) and outer layer. The four layers are combined via ultrasonically welded. The respirator also contains a nose-piece enclosed in a binding tape welding the top edge to conform to the contours of the face. The respirator contains straps to secure the respirator in place on the wearer. The respirator is offered in white. The respirator is provided non-sterile and for single use only.
    Ask a Question
    K Number
    K171116
    Device Name
    3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S
    Manufacturer
    3M Health Care
    Date Cleared
    2017-08-10

    (118 days)

    Product Code
    MSH
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    MSH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask 1804/1804S is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material.
    Device Description
    The 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S are provided as a flat-folded Surgical N95 Respirator composed of multi layers of materials consisting of polypropylene spunbond (inner web), polypropylene (filter web), polypropylene spunbond (outer web). The product contains an aluminum nose clip within the layers of the top edge of the product to conform to the contours of the face. In addition, the product contains two steel staples used to secure the two polyisoprene elastic headbands (not made with natural rubber latex) to the product and the headbands are to secure the product in place on the wearer. The products are provided only in white and provided in two sizes one being small. The 3MM VFlex™ Health Care Particulate Respirator and Surgical Mask, 1804/1804S is an particulate respirator. Particulate respirators help reduce the wearer exposure to certain airborne particles. including those generated by electrocautery, laser surgery and other powered medical instruments. This respirator has a filter efficiency level of at least 95% against particulate aerosols free of oilt. As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials and meets >99% bacterial filtration efficiency (BFE) ±. It is cleared to be worn in surgery. It can fit a wide range of face sizes. CDC guidelines state N95 respirators may be used for M. tuberculosis. *
    Ask a Question
    K Number
    K160271
    Device Name
    N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
    Manufacturer
    SAN-M PACKAGE CO., LTD.
    Date Cleared
    2016-07-15

    (164 days)

    Product Code
    MSH
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    MSH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N95 Particulate Respirator and Surgical Mask, Models TN01-12 are single-use, disposable devices, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Device Description
    The N95 Particulate Respirator and Surgical Mask, Models #TN01-11 and #TN01-12 are NIOSH certified (TC 84A-3348), pouchedshaped respirators when worn. The flat-folded masks are composed of four layers of materials consisting of polypropylene and polyethylene (inner layer), polypropylene meltblown (two filter layers), and polypropylene spunbond (outer layer). The masks contain a conformable nose clamp enclosed in a binding tape welding the top edge to conform to the contours of the face. In addition, the masks contain an ultrasonically welded, polyurethane elastic headband not made with natural rubber latex, to secure the masks in place on the wearer. The masks are offered in orange or white.
    Ask a Question
    K Number
    K141876
    Device Name
    Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator
    Manufacturer
    PASTURE PHARMA PTE LTD
    Date Cleared
    2015-10-28

    (474 days)

    Product Code
    MSH
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    MSH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pasture F550S, Pasture F550CS, Pasture A520S, Pasture A520CS, Pasture E520S, and Pasture E520CS is a NIOSH certified N95 respirator, and is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.
    Device Description
    Pasture F550S and Pasture F550CS respirators are disposable duck bill shaped N95 respirators with NIOSH certification number TC-84A-7504. They contain 5 layers composed of polypropylene, with a nose cushion, a synthetic elastic loop or strap, and a nosepiece which is the combination of zinc wires and embedded polyester inside of layers. F550CS is the same respirator as the F550S, but F550CS contains an adjustable buckle on the headband. Pasture A520S and Pasture A520CS respirators are cup shaped N95 respirators with NIOSH certification number TC-84A-7454. They contain 4 layers composed of polypropylene with a synthetic elastic loop or a strap. A520CS is the same respirator as the A520S, but A520CS contains an adjustable buckle on the headband. Pasture E520S and Pasture E520CS respirators are cup shaped N95 respirators with NIOSH certification number TC-84A-7453. They contain 4 layers composed of polypropylene with a nose cushion, synthetic elastic loop or strap, and an aluminum nosepiece. E520CS is the same respirator as E520S, but E520CS contains an adjustable buckle on the headband.
    Ask a Question
    K Number
    K121069
    Device Name
    3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
    Manufacturer
    3M COMPANY
    Date Cleared
    2013-02-11

    (308 days)

    Product Code
    MSH, PRE
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    MSH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3M™ VFlex™Health Care Particulate Respirator and Surgical Mask 1805/1805S 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.
    Device Description
    The 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask 1805/1805S is an N95 particulate respirator. Particulate respirators help reduce wearer exposure to certain airborne particles, including those generated by electrocautery, laser surgery and other powered medical instruments. This respirator has a filter efficiency level of at least 95% against particulate aerosols free of oil . As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials+ and meets > 99% bacterial filtration efficiency (BFE) *. It is cleared to be worn in surgery. It can fit a wide range of face sizes. This respirator contains no components made from natural rubber latex.
    Ask a Question
    K Number
    K102923
    Device Name
    BARRIER N95 PARTICULATE RESPIRATOR
    Manufacturer
    MOLNLYCKE HEALTHCARE
    Date Cleared
    2010-11-19

    (49 days)

    Product Code
    MSH
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    MSH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device 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.
    Device Description
    Barrier® N95 Particulate Respirators. Models #4273 are NIOSH certified (TC-84A-4350), trapezoid shaped respirators. Barrier® N95 Particulate Respirators, Models #4273 consists of a flat folded disposable face mask that is a piece of three layered non-woven fabric folded in two. An aluminum filament is enclosed in a binding tape welding the top edge, which forms a conformable nose clamp for the purpose of shaping the mask to the contours of the face. It features elastic head bands, ultrasonically welded, to secure the masks in place for the wearer.
    Ask a Question
    K Number
    K102092
    Device Name
    PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES
    Manufacturer
    Prestige Ameritech
    Date Cleared
    2010-10-06

    (71 days)

    Product Code
    MSH
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    MSH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prestige Ameritech N95 Respirator and Surgical Mask RP88020 is a single use non-sterile disposable device intended to be worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
    Device Description
    The Prestige Ameritech N95 Particulate Filter Respirator & Surgical mask is manufactured using ultrasonic bonding, composed of four layers of materials pouched and pleated to form the Mask. The inner layer is composed of nonwoven, the two middle layers is meltblown polypropylene filter material and the outer layer is spunbond polypropylene. Masks are held in place on wearer with latex free elastic headband and contain a malleable aluminum nosepiece strip. All of the materials used in this device are typical materials commonly used in the construction of Respirator and Surgical Masks and are being used in current legally marketed devices.
    Ask a Question
    K Number
    K102173
    Device Name
    MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712
    Manufacturer
    MOLDEX/METRIC, INC.
    Date Cleared
    2010-09-13

    (42 days)

    Product Code
    MSH
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    MSH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask meets CDC Guidelines for TB Exposure Control within healthcare facilities. This device is also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.
    Device Description
    The Moldex-Metric type N95 Healthcare Particulate Respirators and Surgical Masks are constructed from an extruded plastic mesh used in the outer cover and a nonwoven spunbond used in the inner and outer cover. The polypropylene melt blown filter media is layered between the inner and outer cover. The head strap is made of a non-latex rubber stapled to the mask. The inside nosepiece is a closed cell foam.
    Ask a Question
    K Number
    K100139
    Device Name
    SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150
    Manufacturer
    SAFELIFE CORP.
    Date Cleared
    2010-05-04

    (105 days)

    Product Code
    MSH
    Regulation Number
    878.4040
    Why did this record match?
    Product Code :

    MSH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Safe Life B130 and B150 N95 Respirators and Surgical Masks are single-use disposable devices intended to protect healthcare workers and patients from the transfer of microorganisms, blood, body fluids, and airborne particulate materials. These respirators/surgical masks may be used during medical, surgical and dental procedures, and may also be used as isolation masks.
    Device Description
    The Safe Life B130 and B150 N95 Respirators and Surgical Masks are single-use disposable devices.
    Ask a Question

    Page 1 of 4