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510(k) Data Aggregation
K Number
K171550Device Name
Sterile Latex Surgical Gloves, Powder Free
Manufacturer
Sanrea Healthcare Products Pvt Ltd
Date Cleared
2018-07-13
(413 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Sanrea Healthcare Products Pvt Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterile Latex Surgical Gloves, Powder free, is a disposable device made of natural rubber; intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.
Device Description
The subject device is a surgical glove made of natural rubber latex compound. It is sterile, Powder free. The device is anatomic and is hand specific. The device meets ASTM D3577 – 09 : Standard specification for Rubber Surgical Gloves. The device is for over-the counter single use.
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K Number
K171367Device Name
SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)
Manufacturer
Sanrea Healthcare Products Pvt Ltd
Date Cleared
2018-01-26
(262 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Sanrea Healthcare Products Pvt Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterile Latex Patient Examination gloves, Powder Free, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
Device Description
The subject device is a patient examination glove made of latex compound. It is sterile, Powder Free. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D3578-05: Standard specification for Rubber Examination Gloves. The subject device is substantially equivalent to legally marketed Latex Examination Powder Free gloves identified as Product code LYY. The device is for over-the counter single use.
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K Number
K171093Device Name
STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE
Manufacturer
Sanrea Healthcare Products Pvt Ltd
Date Cleared
2017-07-19
(98 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Sanrea Healthcare Products Pvt Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterile Nitrile Patient Examination gloves, Powder free, Blue color, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
Device Description
The subject device is a patient examination glove made of synthetic nitrile latex compound. It is sterile, Powder free and is Blue in colour. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D6319-10: Standard specification for Nitrile Examination Gloves for Medical Application. The subject device is substantially equivalent to legally marketed Nitrile examination gloves identified as Product code LZA. The device is for over-the counter single use.
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