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510(k) Data Aggregation
K Number
K210969Device Name
Nulife
Manufacturer
Date Cleared
2021-11-03
(217 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
MRK Healthcare Pvt Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Sterile Latex Surgical Gloves Powder Free 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, Sterile Latex Surgical Gloves Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile 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, as per standard ASTM D35 77 -09(2015), Standard Specification for Rubber Surgical Gloves. The classification is: Type I - gloves compounded primarily from natural rubber latex. The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of different sizes. All variants share the same natural color (No color additive is added). The proposed device is sterilized using Gamma and ETO method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 5years.
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