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Found 5 results
510(k) Data Aggregation
K Number
K220859Device Name
Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)
Manufacturer
Careglove Global SDN BHD
Date Cleared
2022-09-09
(169 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Careglove Global SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K213993Device Name
Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
Manufacturer
Careglove Global SDN BHD
Date Cleared
2022-08-05
(227 days)
Product Code
LZA, DAT
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Careglove Global SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
It is a powder-free chloroprene patient examination gloves made by on-line polymer-coating and mild on-line chlorination process. The process modifies the surface characteristics without the use of any dusting or donning powder. The gloves are non-sterile, disposable and for single use only.
Characteristics:
- Ambidextrous with beaded cuff
- Blended synthetic latex (Chloroprene and Nitrile Latex)
- Blue or green Coloured ●
- Five sizes: X-Small, Small, Medium, Large and X-Large. ●
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K Number
K190241Device Name
Sterile Latex Surgical Glove, Powder Free
Manufacturer
Careglove Global Sdn Bhd
Date Cleared
2019-12-30
(327 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Careglove Global Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A sterile latex surgical glove, powder free is a disposable device 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 powder-free variation of the class I latex surgical gloves made by on-line polymercoating process. This process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.
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K Number
K172015Device Name
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
Manufacturer
Careglove Global Sdn Bhd
Date Cleared
2017-09-26
(85 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Careglove Global Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tackfree without the use of any dusting or donning powder.
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K Number
K161833Device Name
LATEX EXAMINATION GLOVE POWDER FREE
Manufacturer
CAREGLOVE GLOBAL SDN BHD
Date Cleared
2017-05-23
(322 days)
Product Code
LYY, LAT
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
CAREGLOVE GLOBAL SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
It is the powder-free variation of the class I latex patient examination gloves made by on-line polymercoating and mild on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.
Ask a Question
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