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510(k) Data Aggregation

    K Number
    K232475
    Device Name
    Disposable infusion set with needle
    Manufacturer
    Shandong Zhushi Pharmaceutical Group Co., Ltd
    Date Cleared
    2024-05-10

    (268 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shandong Zhushi Pharmaceutical Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein under the action of gravity.
    Device Description
    The device is a Disposable infusion set with needle. Its configuration includes a Protective Cap of Closure-piercing Device, Closure-piercing Device, Clamp, Fluid channel (tubing), Drip chamber upper cover (including the dropper), Drip chamber, Drip chamber base (including Fluid Filter membrane), Flow regulator, Regulator wheel, Luer Lock Connector, Infusion needle hub, Needle tube, Plastic needle handle, Infusion needle protector, Integral air-inlet with air filter and closure, Tubing, Lubricant, and Adhesives. It has a Tubing Diameter of 4 mm and Filter Characteristics of 15µm. It is available in various Needle Gauges and Lengths.
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    K Number
    K212033
    Device Name
    Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle
    Manufacturer
    Shandong Zhushi Pharmaceutical Group Co., Ltd
    Date Cleared
    2022-08-17

    (414 days)

    Product Code
    FMF, FMI
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shandong Zhushi Pharmaceutical Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Hypodermic Syringe for Single Use with/without need for medical purposes to inject fluid into or withdraw fluid from body. The sterile insulin syringe for single use with needle, with the callbration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The sterile insulin syringe for single use with needle, with the callbration unit of insulin for U-40 is a device intended for medical purposes for the manual aspiration of insulin and for the injection of insulin into parts of the body below the surface skin. The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
    Device Description
    - Disposable Sterile Syringe, with/without needle; luer/luer-lock: Piston, Plunger, Barrel. EO Sterilized. Prescription use. Single use. The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. Length 83-152mm, Diameter 50-31mm, Tip type luer/luer-lock, Needle tip configuration long bevel angle, Nozzle type Luer / Lock, 6% conical, 1,2 mm, Barrel marking specs 0.01ml-0.5ml, Graduation legibility Legible, Needle cover color Transparent, Lubricant composition Dimethicone, Barrel transparency Transparent/ UV resistant, Needle cover strength 15N (min. 2N max. 15N), Hub/needle bond strength min. 22-69 N. Complied with ISO 7886-1, ISO 7864, ISO 9626. Volume 1mL, 2mL, 2.5mL, 3mL, 5mL, 10mL, 20mL, 25mL, 30mL, 50mL. Sizes 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G. Needle Lengths 13-38 mm. Piston material Isoprene Rubber, Barrel material PP, Plunger material PP, Needle material PP, SUS304. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect). - Sterile Insulin Syringe for Single use, with needle: Needle Cap, Needle, Piston, Plunger, Barrel, End Cap. EO Sterilized. Prescription use. Single use. The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. Complied with ISO 8537. Volume 0.5ml, 1ml volumes with fixed needle. Needle Lengths 8mm. Piston material Isoprene Rubber, Barrel material PP, Plunger material PP, Needle material SUS304, Needle Cap material PE, End Cap material PE. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Subchronic Toxicity, Hemolytical effect). - Sterile Hypodermic needle for Single use: Protective cap, Needle, Adhesives, Needle hub. EO Sterilized. Prescription use. Medical professionals and trained care givers. Protective cap, Needle, Adhesives, Needle hub. Single use. For Manual Use Only, For Single Use only. Complied with: ISO 7864, ISO 9626. Sizes 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 30G. Needle Lengths 13-38 mm. Protective cap materials PP, Adhesive Epoxy resin, Needle Hub materials PP, Needle material SUS304. SAL 10-6. Endotoxin Limit 20 EU per device. Biocompatibility Complied with ISO 10993-4/5/10/11 (Cytotoxicity, Irritation, Sensitization Acute Systemic Toxicity, Hemolytical effect).
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    K Number
    K210510
    Device Name
    Disposable Surgical Gown
    Manufacturer
    Shandong Zhushi Pharmaceutical Group Co., Ltd
    Date Cleared
    2021-08-12

    (171 days)

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

    Shandong Zhushi Pharmaceutical Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Surgical Gowns are single use, disposable medical devices, provided sterile.
    Device Description
    The Disposable Surgical Gown is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of polyester elastic closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown
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    K Number
    K210643
    Device Name
    Disposable Surgical Face Mask
    Manufacturer
    Shandong Zhushi Pharmaceutical Group Co., Ltd
    Date Cleared
    2021-08-04

    (154 days)

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

    Shandong Zhushi Pharmaceutical Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face 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(s), provided non sterile. The Disposable Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.
    Device Description
    The Disposable Surgical Face Mask is single use, three-layer, flat-pleated style with ear-loop and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the ear-loop is made of spandex and polyester, and the middle layer is made of melt blown fabrics. During use, the ear-loop shall be tied over user ear. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Disposable Surgical Face Mask is provided in blue color. The mask is sold non-sterile and are intended to be single use, disposable devices.
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    K Number
    K210409
    Device Name
    Disposable Surgical Face Mask
    Manufacturer
    Shandong Zhushi Pharmaceutical Group Co., Ltd
    Date Cleared
    2021-07-28

    (167 days)

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

    Shandong Zhushi Pharmaceutical Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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(s), provided non sterile.
    Device Description
    The Disposable Surgical Face Mask is single use, three-layer, flat-pleated style with tie on and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the tie on are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. During use, the tie on shall be tied over user head. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Disposable Surgical Face Mask is provided in blue color. The mask is sold non-sterile and are intended to be single use, disposable devices.
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    K Number
    K203454
    Device Name
    Infrared Thermometer
    Manufacturer
    Shandong Zhushi Pharmaceutical Group Co., Ltd.
    Date Cleared
    2021-04-29

    (157 days)

    Product Code
    FLL
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shandong Zhushi Pharmaceutical Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Infrared Thermometer (model: ZST-A) is a non-sterile, reusable, non-contact and handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.
    Device Description
    The Infrared Thermometer, Model ZST-A is a non-contact long-distance infrared thermometer which is specialized in measuring human body temperature. It contains buzzer prompt, memory reading, backlight reminder, temperature offset setting, alarm threshold setting, automatic shutdown and common functions of equipment. The Infrared Thermometer measures the temperature by using the principle of receiving infrared. The product is composed of built-in infrared detector and related hardware and software, which can receive, analyze and record the measured object and ambient temperature. Therefore, once the user approaches the specific part of the human body (forehead) and presses the measurement key, the infrared sensor can be activated immediately, and the thermal energy generated by the arterial blood flow can be detected quickly through the passive infrared sensor, so as to accurately measure the body temperature of the human body. The measurement distance of the subject device is 1~5 cm from the middle of the forehead.
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    K Number
    K203436
    Device Name
    Disposable Nitrile Examination Gloves
    Manufacturer
    Shandong Zhushi Pharmaceutical Group Co., Ltd
    Date Cleared
    2021-04-28

    (156 days)

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

    Shandong Zhushi Pharmaceutical Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
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    K Number
    K203439
    Device Name
    Disposable Vinyl Examination Gloves
    Manufacturer
    Shandong Zhushi Pharmaceutical Group Co., Ltd
    Date Cleared
    2021-02-26

    (95 days)

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

    Shandong Zhushi Pharmaceutical Group Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Vinyl Examination Gloves are intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The subject device is powder free vinyl patient examination gloves. The subject device is clear, non-colored. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
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