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510(k) Data Aggregation
K Number
K130301Device Name
LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE)
Manufacturer
ELIMEDICAL DEVICES (FUJIAN) INC.
Date Cleared
2013-08-22
(196 days)
Product Code
KGO, SUR
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ELIMEDICAL DEVICES (FUJIAN) INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 and Powder Free) 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 D3577-0961, the rubber surgical gloves classification is: "Type 1 - gloves compounded primarily from natural rubber latex". The proposed device include Powder Free Latex Surgeon's Gloves, and variations of different size. All variations share the same colour, creamy white. The proposed device is provided radiation sterilized to achieve the Sterility Assurance Level (SAL) of 10% and place in a sterility maintenance package to ensure a shelf life of 3 years.
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