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510(k) Data Aggregation

    K Number
    K193561
    Device Name
    Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
    Date Cleared
    2020-04-15

    (114 days)

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

    Weihai Xingtai Packaging Products Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Disposable Medical Device Self-Seal Sterilization Pouch The Disposable Medical Device Self-Seal Sterilization Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The intended sterilization cycles are listed below: Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time. Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%;100% ethylene oxide at dosage of 759mg/L, 12 hours aeration time at 55℃. 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. The Disposable Medical Device Self-Seal Sterilization Pouch are not intended use for any load with lumer/channels and complex device. The dimension range for each of the weights used in testing: Size 57×102mm: Maximum load weight 400g Size 140x280mm: Maximum load weight 900g Size 305×455mm: Maximum load weight 1600g Disposable Medical Device Sterilization Reel Pouch The Disposable Medical Device Sterilization Reel Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The intended sterilization cycles are listed below: Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time. Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%;100% ethylene oxide at dosage of 759mg/L, 12 hours aeration time at 55°C. 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. The Disposable Medical Device Self-Seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device.
    Device Description
    Disposable Medical Device Self-Seal Sterilization Pouch The Disposable Medical Device Self-Seal Sterilization Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The intended sterilization cycles are listed below: Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time. Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%;100% ethylene oxide at dosage of 759mg/L, 12 hours aeration time at 55℃. 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. The Disposable Medical Device Self-Seal Sterilization Pouch are not intended use for any load with lumer/channels and complex device. The dimension range for each of the weights used in testing: Size 57×102mm: Maximum load weight 400g Size 140x280mm: Maximum load weight 900g Size 305×455mm: Maximum load weight 1600g Disposable Medical Device Sterilization Reel Pouch The Disposable Medical Device Sterilization Reel Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The intended sterilization cycles are listed below: Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time. Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%;100% ethylene oxide at dosage of 759mg/L, 12 hours aeration time at 55°C. 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. The Disposable Medical Device Self-Seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device.
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    K Number
    K183356
    Device Name
    Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
    Date Cleared
    2019-08-19

    (258 days)

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

    Weihai Xingtai Packaging Products Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Medical Device Self-seal Sterilization Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves. The intended sterilization cycles are listed below: Prevacuum steam: 4 minutes at 134 ℃; 10 minute dry time. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The Disposable Medical Device Self-seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1600g of metal instruments. The Disposable Medical Device Sterilization Reel Pouch are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves. The intended sterilization cycles are listed below: Prevacuum steam; 4 minutes at 134 ℃; 10 minute dry time. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The Disposable Medical Device Self-seal Sterilization Pouch are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1600g of metal instruments.
    Device Description
    There are 2 models of the Sterilization Pouches in this application with different physical specification. The Disposable Medical Device Seff-seal Sterilization Pouch is made from a medical grade plastic film that is heat sealed on three sides. The forth side has an adhesive strip that is used to seal the pouch. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam. The Disposable Medical Device Sterilization Reel Pouch are made from a medical grade paper and plastic (PP/PET) film that are heat sealed on opposite two sides. It will be cut to suitable length and the opened sides will be heat-sealed. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.
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