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510(k) Data Aggregation
K Number
K150609Device Name
Annuy Latex Surgeon's Gloves (Powdered and Powder Free)
Manufacturer
Date Cleared
2015-11-16
(251 days)
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ANHUI ANYU 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 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 I - gloves compounded primarily from natural rubber latex". The proposed device includes Powdered and Powder Free Latex Surgeon's Gloves, and variations of different size. All variations share the same color, creamy white. The proposed device is provided 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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K Number
K150612Device Name
Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free)
Manufacturer
Date Cleared
2015-11-16
(251 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ANHUI ANYU LATEX PRODUCTS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Device Description
Annuy Latex Patient Examination Glove (powdered and powder-free) is a glove made from natural rubber that covers the hand up to the wrist. It is cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. It has three sizes, i.e., large, medium, and small. All variations share the same natural color, creamy white. The glove is non-sterile and is for single use only, to be discarded after each examination is performed. It acts as a barrier between the examiner and the subject being examined in order to prevent contamination between them.
Annuy Nitrile Patient Examination Glove (powdered and powder-free) is a glove made from nitrile butadiene rubber Latex that covers the hand up to the wrist. It is cuffed and equally wearable on either hand, free from differentiation between the left hand and the right. It has three sizes, i.e. large, medium, and small. All variations share the same blue color. The glove is non-sterile and is for single use only, to be discarded after each examination is performed. It acts as a barrier between the examiner and the subject being examined in order to prevent contamination between them.
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