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510(k) Data Aggregation
K Number
K052728Device Name
POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES
Manufacturer
M/S. KANAM LATEX INDUSTRIES PVT. LTD.
Date Cleared
2005-12-05
(67 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
KANAM LATEX INDUSTRIES PVT. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Powder Free Patient Examination Glove is a Disposable Device made of Natural Rubber -Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Device Description
A Powder Free Patient Examination Glove is a Disposable Device made of Natural Rubber -Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
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K Number
K052214Device Name
PRE-POWDERED STERILE EXAM GLOVES
Manufacturer
KANAM LATEX INDUSTRIES PVT. LTD.
Date Cleared
2005-09-13
(29 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
KANAM LATEX INDUSTRIES PVT. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Powdered Patient Examination Glove is a Disposable Device made of Natural Rubber Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Device Description
PRE-POWDERED LATEX STERILE PATIENT EXAMINATION GLOVES
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K Number
K033564Device Name
POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM2
Manufacturer
KANAM LATEX INDUSTRIES PVT. LTD.
Date Cleared
2004-02-24
(104 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
KANAM LATEX INDUSTRIES PVT. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Polymer coated, Powderfree Sterile Surgeon's Glove is to be worn by Operating Room Personnel to protect a Surgical Would from contamination.
Device Description
POWDERFREE LATEX SURGEON'S GLOVES POLYMER COATED STERILE Contains 50 micrograms or less of Total water extractable protein per gram
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K Number
K013914Device Name
POWDERFREE LATEX SURGEON'S GLOVES
Manufacturer
KANAM LATEX INDUSTRIES PVT. LTD.
Date Cleared
2002-02-06
(71 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
KANAM LATEX INDUSTRIES PVT. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Powder - free surgeon's glove is a disposable device made of natural latex that may bear a trace amount of glove powder but not more than 2 milligrams per glove may bour a trace anounces on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contamination.
Device Description
Powder Free Latex Surgeon's Gloves with Protein Contact Labeling Claim (50 Micrograms or Less)
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