Search Results
Found 3 results
510(k) Data Aggregation
K Number
K242898Device Name
Sterilization Pouches and Reels
Manufacturer
Shanghai Jianzhong Medical Packaging Co., Ltd.
Date Cleared
2025-02-21
(151 days)
Product Code
FRG, JOJ, SUB
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Jianzhong Medical Packaging Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterilization Pouches and Reels is intended to provide health care workers with an effective method to enclosed devices in a single or double pouch configuration by steam or ethylene oxide sterilization. The recommended sterilization cycle parameters are as follows:
a) Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 ℃ (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F).
The Sterilization Pouches and Reels is composed of medical compound film, maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture. The pouch's external chemical indicators are designed to indicate to the user that the pouch has undergone either a steam or EO Sterilization indicators will change color according to the sterilization method (Steam, Ethylene oxide). The color of steam sterilization indicator changes from Pink before sterilization to Cocoa after sterilization. The color of Ethylene oxide sterilization indicator changes from Blue before sterilization to Golden Brown after sterilization. The maximum validated pouch load is 1.87 lbs. (850g); The maximum validated reel load is 1.87 lbs. (850 g)
Device Description
The Sterilization Pouches and Reels is composed of medical compound film. It is intended to be used to contain medical devices to be terminally sterilized by Steam or EO sterilization process. The recommended sterilization cycle parameters are as follows:
- Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. a)
- b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 °C (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F).
The medical devices are inserted into the Pouches/Reels, and then sterilized for the EO or Steam Sterilization Process. The heat-sealed Pouches/Reels are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouches/Reels maintain sterility of the enclosed medical devices until the seal is opened. The Sterilization Pouches and Reels maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture.
The Sterilization Pouches and Reels is printed with chemical indicator bars that changed from Pink to Cocoa(Steam) or Blue to Golden Brown (EO) when exposed to steam vapor or EO gas during process. The steam and EO chemical indicator offer an addition way to verify processing in the sterilization cycle. The chemical indicator should be used in addition to, not in place of, the biological indicator. The steam and EO chemical indicators do not signify sterilization; they only indicate that the indicators have been exposed to the Steam or EO.
Ask a Question
K Number
K202341Device Name
Disposable Surgical Mask
Manufacturer
Shanghai Jianzhong Medical Packaging Co., Ltd.
Date Cleared
2021-02-12
(179 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Jianzhong Medical Packaging Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are 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 and sterile.
Device Description
The proposed device, Disposable Surgical Mask is a three-layer, flat-folded mask with ear strap and nose clip. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The color of the surgical mask is blue. The disposable surgical mask is available in three different specifications: 17.5*9.5cm, 14.5*9.5cm and 14.5*8cm. The device is single use and provided non-sterile and sterile.
Ask a Question
K Number
K071886Device Name
SELF SEAL STERILIZATION POUCH
Manufacturer
SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD.
Date Cleared
2007-12-27
(171 days)
Product Code
FRG
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1