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510(k) Data Aggregation
K Number
K142992Device Name
TULIP Natural Rubber Latex Surgeon's Glove (Powdered)
Manufacturer
Date Cleared
2015-03-18
(153 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI JINXIANG LATEX PRODUCTS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
The proposed device. Latex Surgeon's Gloves Powdered is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, per standard ASTM D3577-096', the rubber surgical gloves classification is: "Type I - gloves compounded primarily from natural rubber latex". The proposed device is Powdered Latex Surgeon's Gloves, and variations of different size. All variations share the same color, creamy white. The proposed device is provided Gamma radiation sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and place in a sterility maintenance package to ensure a shelf life of 3 years.
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