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Found 4 results
510(k) Data Aggregation
K Number
K221164Device Name
Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl
Manufacturer
Date Cleared
2022-08-30
(130 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hong Seng Gloves SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Nitrile 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. These specialty gloves were tested for use with Chemotherapy drugs and Fentanyl.
Device Description
POWDER FREE NITRILE EXAMINATION GLOVE - Blue, NON STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
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K Number
K212801Device Name
Powder free nitrile examination glove- black, non sterile
Manufacturer
Date Cleared
2022-01-09
(129 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hong Seng Gloves Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device made of Nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder Free Nitrile Examination Glove - Black, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from Nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the qloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand and it is a single use device.
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K Number
K212802Device Name
powder free nitrile examination glove - white, non-sterile
Manufacturer
Date Cleared
2021-12-02
(91 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hong Seng Gloves Sdn Bhd
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
The powder free nitrile examination glove is manufactured from nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.
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K Number
K212804Device Name
Powder free nitrile examination glove- blue, non-sterile
Manufacturer
Date Cleared
2021-12-01
(90 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hong Seng Gloves Sdn Bhd
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
Powder Free Nitrile Examination Glove - Blue, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.
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