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510(k) Data Aggregation
K Number
K223559Device Name
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)
Manufacturer
Date Cleared
2023-02-09
(73 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Nephron Pharmaceuticals Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:
Bleomycin Sulfate (15.0 mg/ml)
Busulfan (6.0 mg/ml)
Carboplatin (10.0 mg/ml)
Cisplatin (1.0 mg/ml)
Cyclophosphamide (20.0 mg/ml)
Cytarabine (100.0 mg/ml)
Dacarbazine (10.0 mg/ml)
Daunorubicin HCl (5.0 mg/ml)
Docetaxel (10.0 mg/ml)
Doxorubicin HCl (2.0 mg/ml)
Epirubicin HCl (2.0 mg/ml)
Etoposide (20.0 mg/ml)
Fludarabine (25.0 mg/ml)
Fluorouracil (50.0 mg/ml)
Gemcitabine (38.0 mg/ml)
Idarubicin HCl (1.0 mg/ml)
Ifosfamide (50.0 mg/ml)
Irinotecan (20.0 mg/ml)
Mechlorethamine HCl (1.0 mg/ml)
Melphalan (5.0 mg/ml)
Methotrexate (25.0 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone HCl (2.0 mg/ml)
Paclitaxel (6.0 mg/ml)
Rituximab (10.0 mg/ml)
Trisenox (1.0 mg/ml)
Vincristine Sulfate (1.0 mg/ml)
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml) : 33.8 minutes Thiotepa (10.0 mg/ml) : 128.1 minutes
Warning: Not for Use with: Carmustine, Thiotepa
Device Description
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a Class I, patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff and single use only.
Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) with sizes Medium, Large, X-Large and XX-Large are included in the submission.
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