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510(k) Data Aggregation

    K Number
    K233723
    Device Name
    Medical surgical mask
    Manufacturer
    Guangdong Kingfa Sci. & Tech. Co., LTD.
    Date Cleared
    2024-07-29

    (251 days)

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

    Guangdong Kingfa Sci. & Tech

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K231155
    Device Name
    Biodegradable Medical surgical mask
    Manufacturer
    Guangdong Kingfa Sci. & Tech. Co., Ltd.
    Date Cleared
    2023-11-07

    (197 days)

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

    Guangdong Kingfa Sci. & Tech

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.
    Device Description
    The Medical surgical mask is flat pleated style mask, utilizing ear loops way for wearing, and has nose piece design for fitting the Medical surgical mask around the nose. The Medical surgical mask is provided non-sterile and is intended to be a single use, disposable device.
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    K Number
    K221983
    Device Name
    Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color
    Manufacturer
    Guangdong Kingfa Sci. & Tech. Co., LTD.
    Date Cleared
    2023-04-27

    (295 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangdong Kingfa Sci. & Tech

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The biodegradable nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
    Device Description
    The propose devices is powder free nitrile patient examination gloves, provided as non-sterile and disposable device. The gloves are offered in six sizes, extra-small (6.5"), small (7"), medium (8"), large (8.5"), extra-large (9"), extra extra-large (9.5"). Three colors are available for all size, includes blue, blue violet and green.
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    K Number
    K230046
    Device Name
    Vinyl examination gloves
    Manufacturer
    Guangdong Kingfa Sci.& Tech.Co., Ltd.
    Date Cleared
    2023-03-25

    (78 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangdong Kingfa Sci.& Tech

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The vinyl examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.
    Device Description
    The proposed device is a powder free vinyl patient examination glove, provided as nonsterile and disposable device. The proposed device is provided with clear color. There are four sizes: small, medium, large and extra-large as options.
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    K Number
    K222612
    Device Name
    Powder-Free Latex examination gloves
    Manufacturer
    Guangdong Kingfa Sci.&Tech. Co., Ltd.
    Date Cleared
    2022-11-25

    (87 days)

    Product Code
    LYY
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangdong Kingfa Sci.&Tech

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner.
    Device Description
    The proposed device is Powder-Free Latex Examination Gloves. The gloves are single use and are provided non-sterile. The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The proposed device is provided with natural color. The device is available in two lengths, each with six sizes, extra-small (XS), small (S), medium (M), large (L) and extra-large (XL), and extra extra-large (XXL). The device is non-sterile.
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    K Number
    K221887
    Device Name
    Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color
    Manufacturer
    Guangdong Kingfa Sci. & Tech. Co., Ltd.
    Date Cleared
    2022-09-24

    (87 days)

    Product Code
    LZA, DAT
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangdong Kingfa Sci. & Tech

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
    Device Description
    The propose devices is powder free nitrile patient examination gloves, provided as non-sterile and disposable device. The proposed devices are provided with white, black and pink color. There are six sizes, extra-small, medium, large and extra-large, extra extra-large for optional.
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    K Number
    K213450
    Device Name
    Medical surgical mask (Black mask, Level 1 and Level 3)
    Manufacturer
    Guangdong Kingfa Sci.&Tech. Co., Ltd.
    Date Cleared
    2022-04-05

    (161 days)

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

    Guangdong Kingfa Sci.&Tech

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.
    Device Description
    The medical surgical mask (model: Black mask, Level 3) is a flat pleated style mask with ear loops, and a nose piece design for fitting the mask around the nose. The mask is manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt-blown polypropylene. Ear loops are held to cover the users' mouth and nose by two polypropylene bands ultrasonically welded to the mask. The elastic ear loops are not made with natural rubber latex. The nose piece included in the mask is in the middle layer of the mask, to allow the user to fit the mask around their noses. The mask will be provided in black color, the colorant for the masks is Carbon black (CAS No.1333-86-4). The subject device has 2 kinds of dimensions: 17.5 cm x 9.5 cm and 14.5 cm x 9.5 cm, and 2 kinds of protection performance: Level 1 and Level 3. The mask is sold non-sterile and intended to be a single-use, disposable device.
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    K Number
    K211220
    Device Name
    Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs
    Manufacturer
    Guangdong Kingfa Sci. & Tech. Co., Ltd.
    Date Cleared
    2021-07-22

    (90 days)

    Product Code
    LZA, LZC, OPJ
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangdong Kingfa Sci. & Tech

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/ml 65.3 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 58.3minutes
    Device Description
    Power-Free Nitrile Examination Gloves(Tested for Use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are powder-free, ambidextrous with beaded cuff, Blue/Blue violet colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in four sizes, small, medium, large and extra-large. The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).
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    K Number
    K202107
    Device Name
    Medical Protective Mask
    Manufacturer
    Guangdong Kingfa Sci.&Tech.Co., Ltd.
    Date Cleared
    2021-01-15

    (170 days)

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

    Guangdong Kingfa Sci.&Tech

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Medical Protective Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
    Device Description
    The Medical Protective Mask is a single use, two-panel, flat-folded mask with ear loops and nose piece. The mask is designed into a C-shape when flat-folded. The C-shaped design allows for an expanded chamber for the mask in use. The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The elastic ear loops are made of spandex and polyester, which are welded to the facemask to hold the mask in place over the users' mouth and nose. The elastic ear loops are not made with natural rubber latex. The nose piece is a Iron core covered with polypropylene. The dimensions of each mask are length 162±5 mm and width 102±5 mm. The dimensions of nosepiece is length 90±10 mm and width 5±0.5 mm, and the ear loop is length 185±5 mm and width 5±0.5 mm. The mask is a single use, disposable device, provided non-sterile in white color.
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    K Number
    K201622
    Device Name
    Medical surgical mask
    Manufacturer
    Guangdong KINGFA Sci.&Tech.Co.,Ltd.
    Date Cleared
    2020-11-24

    (162 days)

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

    Guangdong KINGFA Sci.&Tech

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.
    Device Description
    The Medical surgical mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Medical surgical mask around the nose. The Medical surgical mask is manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, only the outer layers' color is blue (colorant: Pigment Blue K6911D /CAS number: 12239-87-1), and the middle layer is made of melt blown polypropylene. Ear loops, which is held to cover the users' mouth and nose by two polyester and spandex elastic bands ultrasonic welded to the Medical surgical mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the Medical surgical mask is in the middle layer of Medical surgical mask to allow the user to fit the Medical surgical mask around their noses, which is made of metallic iron wire coated with polypropylene resin. The dimensions of each Medical surgical mask are length 175±5 mm and width 95±2 mm, and the inner and outer layers' density are 25 gsm, the middle layer is 35 gsm. The dimensions of nosepiece is length 100±5 mm and width 3±0.5 mm, and the ear loop is length 175±10 mm and width 3.5±0.5 mm. The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device.
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