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510(k) Data Aggregation
K Number
K182184Device Name
Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)
Manufacturer
Date Cleared
2019-10-10
(423 days)
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
MDK (ShangHai) Medical Packing Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sterilization Pouch Flat 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 Sterilization Pouch Flat are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The intended sterilization cycles are listed below:
Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60℃.
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 Sterilization Pouch Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1470 g. The sterilization pouch maintains the enclosed devices up until 6 months post sterilization.
Sterilization Pouch Gusseted
The Sterilization Pouch Gusseted 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 sterlity of the enclosed device until used. The Sterilization Pouch Gusseted are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The intended sterilization cycles are listed below:
Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60°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 Sterilization Pouch Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1470g. The sterilization pouch maintains the enclosed devices up until 6 months post sterilization.
Sterilization Roll Flat
The Sterilization Roll Flat 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 Sterilization Roll Flat are intended for sterilization of dental instruments, excluding complex devices and instruments with lumen/channels).
The intended sterilization cycles are listed below:
Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60℃.
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 Sterilization Roll Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 910g. The sterilization roll maintains the enclosed devices up until 6 months post sterilization.
Sterilization Roll Gusseted
The Sterilization Roll Gusseted 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 sterlity of the enclosed device until used. The Sterilization Roll Gusseted are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The intended sterilization cycles are listed below:
Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60°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 Sterilization Roll Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 910g. The sterilization roll maintains the enclosed devices up until 6 months post sterilization.
Device Description
The Paper Sterilization Pouch and Roll is intended to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process. The recommended sterilization cycle parameter is:
Steam; 30 minutes at 121°C; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60 ℃.
The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the EtO or Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.
The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 6 months post sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from Red/Pink to Yellow/Brown (EtO) or Blue to Brown/Black (Steam) when exposed to EtO gas or Steam vapor during process. The EtO and Steam Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.
The Paper Sterilization Pouch and Roll is offered in the follow 4 types:
* Sterilization Pouch Flat;
* Sterilization Pouch Gusseted;
* Sterilization Pouch Roll Flat;
* Sterilization Pouch Roll Gusseted.
The defining characteristics of the 4 types as follows:
Sterilization Pouch Flat: These pouches are made from a medical grade paper and plastic (CPP/PET) film that is heat sealed on three sides, the forth side is left opened and will be heat-sealed when using. The Process Indicators Ink printed on the Pouch will exhibit a color change after the pouch is exposed to EtO gas or Steam.
Sterilization Pouch Gusseted: These rolls are the same as the Sterilization Pouch Flat, with the Heat Sealing except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
Sterilization Roll Flat: These rolls are made from a medical grade paper and plastic (CPP/PET) film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on it are the same as the sterilization pouches.
Sterilization Roll Gusseted: These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
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