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510(k) Data Aggregation
K Number
K182656Device Name
JAMBRO Single Core A Sterilization wrap
Manufacturer
Date Cleared
2019-06-11
(259 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Zhande Medical Supplies Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
JAMBRO Single Core A is intended to be used to enclose another medical device that is to be sterilized by a health care provider using:
- · Gravity steam at 250°F/121°C for 30 minutes
- · Pre-vacuum steam at 270°F/132°C for 4 minutes
Gravity steam and Pre-vacuum steam sterilization: Validated for dry times of 30 minutes for JAMBRO Single Core A
Types of medical devices to be sterilized in the gravity cycle;
· General purpose non-lumened reusable metal and nonmetal devices with stainless steel diffusionrestricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
Types of medical devices to be sterilized in the pre-vacuum cycle are;
· General purpose reusable metal and nonmetal devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc.
· Up to 2 single channel stainless steel lumened devices of the following dimensions; An inside diameter of 3 mm or larger and a length of 400 mm or shorter;
Color of wrap: Blue Size of wrap: 48 in x 48 in
The maximum validated weight of load for JAMBRO Single Core A is 25 lbs.
The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.
Device Description
JAMBRO Single Core A is a 63gsm, latex-free, 3-layer (SMS) non-woven sterile wrap, manufactured with spun-bonded / meltblown polypropylenem. JAMBRO Single Core A provides a strong barrier which protects against cuts, tears with particularly heavy orthopedic sets. JAMBRO Single Core A is designed to be implemented as an outer sterilization wrap which can be used in combination with Clinipak choice.
The Maximum Recommended Wrapped Package Content Weights for the JAMBRO Single Core A (63g/m²) is 25 lbs.
The Intended Load for the JAMBRO Single Core A (63g/m²) is moderate to heavy weight package (e.g., general use medical instruments) and the JAMBRO Single Core A can maintain sterility of sterilized devices for 90 days.
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