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510(k) Data Aggregation
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Applicant Name (Manufacturer) :
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This is a disposable device intended for medical application that is worn on the examiner's hand to prevent contamination between examiner and patient and to protect examiner from the following Chemotherapy drugs tested to ASTM D 6978 with the indicated Breakthrough Detection Times :
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.
Nitrile Powder Free Examination Glove (Blue)
* CAUTION: Testing showed average breakthrough time of 40.00minutes with Carmustine.
Nitrile Powder Free Examination Glove (Green)
* WARNING: DO NOT USE WITH CARMUTINE.
Nitrile Powder Free Examination Glove (White)
* CAUTION: Testing showed average breakthrough time of 48.00minutes with Thio-Tepa.
* WARNING: DO NOT USE WITH CARMUTINE.
Device Description
Non Sterile. Powder-Free. Nitrile Examination for Use with Chemotherapy Drugs
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K Number
K060229Device Name
POWDER-FREE BLACK LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTE
Date Cleared
2006-03-15
(44 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Non-Sterile, Powder-Free, Black Latex Examination Gloves, with Protein Labeling Claim (50 micrograms or less of total water extractable protein per gram of glove) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Non-Sterile, Powder-Free, Black Latex Examination Gloves, with Protein Labeling Claim (50 micrograms or less of total water soluble protein per gram of glove)
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K Number
K052030Device Name
SURGEON'S GLOVE, POWDER FREE
Date Cleared
2005-09-13
(48 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Royal Guard Latex, Powder-Free, Surgeon's Glove - Sterile, is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between patient and operating room personnel.
Device Description
The Royal Guard Latex, Powder-Free, Surgeon's Glove - Sterile, is a device made of natural or synthetic rubber.
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K Number
K052031Device Name
POWDERED LATEX SURGEON'S GLOVE
Date Cleared
2005-09-12
(47 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The powdered latex surgeon's glove with protein content labeling claim (200 micrograms or less per gram) is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between patient and operating room personnel.
Device Description
Powdered Latex Surgeon's Glove with Protein Content Labeling Claim (200 Micrograms or Less per Gram)
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K Number
K040406Device Name
POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)
Date Cleared
2004-05-14
(87 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for manuations . or er es that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
POLYMER COATED, CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (less than 50 ug/g per glove)
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K Number
K040408Device Name
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)
Date Cleared
2004-03-17
(29 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC 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 finger to prevent contamination between patient and examiner
Device Description
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (less than 50 ug/g per glove)
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