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510(k) Data Aggregation
K Number
K240930Device Name
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue
Date Cleared
2024-07-02
(89 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Sri Trang Gloves Thailand (Public Company Limited)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
THIS DEVICE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
The tested chemotherapy drugs and permeation times are as follows:
Bleomycin Sulfate 15 mg/mL. >240 minutes Busulfan 6 mg/mL, >240 minutes Carboplatin (Paraplatin) 10 mg/mL, >240 minutes Carmustine (BCNU) 3.3 mg/mL, 23.5 minutes Cisplatin 1.0 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL. >240 minutes Cytarabine 100 mg/mL, >240 minutes Dacarbazine (DTIC) IO mg/mL, >240 minutes Daunorubicin 5 mg/mL, >240 minutes Docetaxel IO mg/mL, >240 minutes Doxorubicin Hydrochloride 2 mg/mL, >240 minutes Epirubicin (Ellence) 2 mg/mL, >240 minutes Etoposide (Toposar) 20 mg/mL, >240 minutes Fludarabine 25 mg/mL, >240 minutes Fluorouracil 50 mg/mL, >240 minutes Gemcitabine 38 mg/mL, >240 minutes Idarubicin 1 mg/mL, >240 minutes Bendamustine (5.0 mg / ml), > 240 minutes Oxaliplatin (5.0 mg / ml), > 240 minutes Azacitidine (Vidaza] (25.0 mg / ml) ,> 240 minutes Capecitabine (26.0 mg / ml), > 240 minutes Cladribine (1.0 mg / ml), > 240 minutes Decitabine (5.0 mg / ml) ,> 240 minutes Pemetrexed (25.0 mg / ml), > 240 minutes Raltitrexed (0.5 mg / ml), > 240 minutes Actinomycin D (0.5mg / ml)(Dactinomycin), > 240 minutes Vinorelbine (10.0 mg / ml), > 240 minutes Vinblastine (1.0 mg / ml), > 240 minutes
Fentanyl tested as follows; Fentanyl citrate 100 mcg/2mL. >240 minutes
WARNING: Not for use with Carmustine or Thiotepa.
lfosfamide 50 mg/mL. >240 minutes Irinotecan 20 mg/mL. >240 minutes Mechlorethamine I mg/mL, >240 minutes Melphalan 5 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Mitomycin C 0.5 mg/mL. >240 minutes Mitoxantrone 2 mg/mL, >240 minutes Paclitaxel (Taxol) 6 mg/mL, >240 minutes Rituximab 10 mg/mL. >240 minutes Thiotepa 10 mg/mL, 37.9 minutes Trisenox 1 mg/mL . >240 minutes Vincristine Sulfate I mg/mL, >240 minutes Topotecan (1.0 mg / ml), >240 minutes Carfilzomib (2.0 mg / ml), >240 minutes Cetuximab [Erbitux] (2.0 mg / ml), > 240 minutes Temsirolimus (25.0 mg / ml), > 240 minutes Bortezomib [Velcade] (1.0 mg / ml), > 240 minutes Fulvestrant (50.0mg / ml),> 240 minutes Leuprorelin acetate (5.0 mg / ml), > 240 minutes Ganciclovir [Cytovene] (10.0 mg / ml), > 240 minutes Zidopusin (Retrovir) (10.0 mg / ml), > 240 minutes Zoledronic acid (0.8 mg / ml), > 240 minutes Triclosan (3.0 mg / ml), > 240 minutes Chloroquine (50.0 mg / ml), > 240 minutes Cyclosporine A (100.0 mg / ml) , > 240 minutes Propofol (10 mg/ml) (Diprivan), > 240 minutes MESNA (100 mg/ml), > 240 minutes
Device Description
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl-Blue. THIS DEVICE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
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