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510(k) Data Aggregation

    K Number
    K243721
    Device Name
    Self Sealing Sterilization Pouches
    Manufacturer
    Wellmed Dental Medical Supply Co., Ltd
    Date Cleared
    2025-04-25

    (143 days)

    Product Code
    FRG, JOJ
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wellmed Dental Medical Supply Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Self Sealing Sterilization Pouches are intended to be used to enclose another medical devices that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The Self Sealing Sterilization Pouches are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The recommended sterilization cycles are as follows: • Steam Sterilization: 4 minutes at 132°C (270°F); 10 minutes dry time for gauze and plastic loads, and 20 minutes dry time for metal loads. • Ethylene Oxide (ETO) Sterilization: 8 hours at 50°C (122°F); relative humidity between 30%-90%; ethylene oxide concentration is 700mg/L, 7 days aeration time at 23°C(73.5°F). The Self Sealing Sterilization Pouches are made with medical grade paper and medical compound film. The Self Sealing Sterilization Pouch maintains the sterility of the enclosed devices for up to 6 months post Steam or ETO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or ETO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from pink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark green after sterilization.
    Device Description
    The Self Sealing Sterilization Pouches are made with medical grade paper and medical compound film. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or ETO sterilization process.
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    K Number
    K242435
    Device Name
    Dental Barrier and Sleeves
    Manufacturer
    Wellmed Dental Medical Supply Co., Ltd
    Date Cleared
    2024-10-18

    (63 days)

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

    Wellmed Dental Medical Supply Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Barrier and Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
    Device Description
    Not Found
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    K Number
    K222697
    Device Name
    Disposable Medical Face Mask (DF3-001)
    Manufacturer
    Wellmed Dental Medical Supply Co., Ltd.
    Date Cleared
    2022-11-04

    (58 days)

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

    Wellmed Dental Medical Supply Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Medical Face Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical 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 Proposed device(s) are blue color, and pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene ,metal wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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