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Found 4 results
510(k) Data Aggregation
K Number
K250193Device Name
Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)
Manufacturer
Basic Medical Technology Inc.
Date Cleared
2025-07-09
(167 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Basic Medical Technology Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K250630Device Name
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
Manufacturer
Basic Medical Technology Inc.
Date Cleared
2025-05-22
(80 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Basic Medical Technology Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl, Gastric acid and Xylazine in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Device Description
Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are non-sterile, powder-free, fingertip textured, ambidextrous with beaded cuff, blue colored nitrile gloves featuring an inner coating of hyaluronic acid and single use only. There are six different sizes- XS, S, M, L, XL and XXL. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs, opioid Fentanyl Citrate, simulated Gastric Acid and Xylazine per ASTM D6978-05.
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K Number
K243792Device Name
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)
Manufacturer
Basic Medical Technology Inc.
Date Cleared
2025-02-18
(70 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Basic Medical Technology Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black/White) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with Chemotherapy drugs and Fentanyl using ASTM D6978-05.
Device Description
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black, White) is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are non-sterile, powder-free, fingertip textured, ambidextrous with beaded cuff, and single use only, and come in different sizes- XS, S, M, L, XL and XXL. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs and Fentanyl Citrate.
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K Number
K243441Device Name
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)
Manufacturer
Basic Medical Technology Inc.
Date Cleared
2025-01-31
(86 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Basic Medical Technology Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The glove is disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves were tested for use with Chemotherapy drugs, Fentanyl and Gastric acid in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Device Description
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are non-sterile, powder-free, fingertip textured, ambidextrous with beaded cuff, and single use only, and come in different sizes- XS, S, M, L, XL and XXL.
Ask a Question
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