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510(k) Data Aggregation
K Number
K241745Device Name
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)
Manufacturer
Date Cleared
2024-09-11
(85 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
KSG Medicare Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Nitrile powder free examination glove is a disposable device intended purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specialty glove has also been tested for use with 46 Chemotherapy drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate.
Device Description
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)
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K Number
K220209Device Name
Powder Free Nitrile Examination Glove, Non-sterile (Blue)
Manufacturer
Date Cleared
2022-04-11
(75 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
KSG MEDICARE Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the hand or finger to prevent contamination between examiner and patient.
Device Description
Powder Free Nitrile Examination Glove, Non-sterile (Blue)
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K Number
K220215Device Name
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)
Manufacturer
Date Cleared
2022-03-26
(59 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
KSG MEDICARE Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specialty glove has also been tested for use with Chemotherapy Drugs and the Opioid Fentanyl citrate, simulated Gastric Acid and Fentanyl in Gastric Acid.
Device Description
Powder Free Nitrile Examination Glove, Non-Sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue)
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