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Found 7 results
510(k) Data Aggregation
K Number
K222298Device Name
Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
Manufacturer
Date Cleared
2022-10-18
(78 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Onetexx SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This Nitrile 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, and has also been Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid.
Device Description
Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
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K Number
K222294Device Name
Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
Manufacturer
Date Cleared
2022-09-24
(54 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Onetexx SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This Nitrile 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, and has also been Tested for Use with the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid.
Device Description
Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
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K Number
K221773Device Name
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid
Manufacturer
Date Cleared
2022-07-30
(39 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ONETEXX SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K210588Device Name
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
Manufacturer
Date Cleared
2021-10-31
(247 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Onetexx 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
Nitrile Powder Free Patient 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 synthetic rubber latex. 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
K210587Device Name
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
Manufacturer
Date Cleared
2021-06-28
(122 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Onetexx 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
Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile meets all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from Nitrile latex. 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
K210775Device Name
White Nitrile Powder Free Patient Examination Glove, Non Sterile
Manufacturer
Date Cleared
2021-06-28
(105 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Onetexx 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
White Nitrile Powder Free Patient Examination Glove, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from synthetic rubber latex. 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
K210366Device Name
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
Manufacturer
Date Cleared
2021-05-07
(88 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Onetexx 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
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from synthetic rubber latex. 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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