# K250193: Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)

- Pathway: 510(k) (Traditional)
- Applicant: Basic Medical Technology, Inc.
- Decided: Jul 9, 2025 after 167 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for 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. Light Blue glove: Chemotherapy Drugs 1 Bendamustine HCI, 5 mg/ml 2 Bortezomib (Velcade), 1 mg/ml 3 Busulfan, 6 mg/ml 4 Carboplatin, 10 mg/ml 5 Carmustine, 3.3 mg/ml 6 Carfilzomib, 2 mg/ml 7 Cetuximab (Erbitux), 2 mg/ml 8 Chloroquine, 50mg/ml 9 Cisplatin, 1 mg/ml 10 Cladribine, 1.0 mg/ml 11 Cyclophosphamide, 20 mg/ml 12 Cyclosporin A,100mg/ml 13 Cytarabine HCI, 100 mg/ml 14 Cytovene, 10 mg/ml 15 Dacarbazine, 10 mg/ml 16 Daunorubicin HCI, 5 mg/ml 17 Decitabine, 5 mg/ml 18 Docetaxel, 10 mg/ml 19 Doxorubicin HCI, 2 mg/ml 20 Epirubicin HCI, 2 mg/ml 21 Etoposide, 20 mg/ml 22 Fludarabine Phosphate, 25 mg/ml 23 5-Fluorouracil, 50 mg/ml 24 Gemcitabine HCI, 38 mg/ml 25 Idarubicin HCI, 1 mg/ml 26 Ifosfamide, 50 mg/ml 27 Irinotecan HCI, 20 mg/ml 28 Mechlorethamine HCI, 1 mg/ml 29 Melphalan HCI, 5 mg/ml 31 Methotrexate, 25 mg/ml 30 Mitomycin-C, 0.5 mg/ml 32 Mitoxantrone HCI, 2 mg/ml 33 Oxaliplatin, 2 mg/ml 34 Pacilitaxel, 6 mg/ml 35 Retrovir, 10 mg/ml 36 ThioTEPA, 10 mg/ml 37 Trisonex, 1 mg/ml 38 Vidaza(Azacitidine),25 mg/ml 39 Vincristine Sulfate,1 mg/ml Fentanyl, Gastric Acid and Xylazine 1 Fentanyl Citrate Injection,50mcg/ml 2 Gastric Acid 3 Fentanyl Citrate: Xylazine HCL, 50:50 *Please note that the following drugs have extremely low permeation times: Carmustine: 12.6 minutes, Thio Tepa:27.1 minutes Warning: Do not use with Carmustine and Thiotepa. Dark Blue Glove: Chemotherapy Drugs 1 Bendamustine HCI, 5 mg/ml 2 Bortezomib (Velcade), 1 mg/ml 3 Busulfan, 6 mg/ml 4 Carboplatin, 10 mg/ml 5 Carmustine, 3.3 mg/ml 6 Carfilzomib, 2 mg/ml 7 Cetuximab (Erbitux), 2 mg/ml 8 Chloroquine, 50mg/ml 9 Cisplatin, 1 mg/ml 10 Cladribine, 1.0 mg/ml 11 Cyclophosphamide, 20 mg/ml 12 Cyclosporin A,100mg/ml 13 Cytarabine HCI, 100 mg/ml 14 Cytovene, 10 mg/ml 15 Dacarbazine, 10 mg/ml 16 Daunorubicin HCI, 5 mg/ml 17 Decitabine, 5 mg/ml 18 Docetaxel, 10 mg/ml 19 Doxorubicin HCI, 2 mg/ml 20 Epirubicin HCI, 2 mg/ml 21 Etoposide, 20 mg/ml 22 Fludarabine Phosphate, 25 mg/ml 23 5-Fluorouracil, 50 mg/ml 24 Gemcitabine HCI, 38 mg/ml 25 Idarubicin HCI, 1 mg/ml 26 Ifosfamide, 50 mg/ml 27 Irinotecan HCI, 20 mg/ml 28 Mechlorethamine HCI, 1 mg/ml 29 Melphalan HCI, 5 mg/ml 31 Methotrexate, 25 mg/ml 30 Mitomycin-C, 0.5 mg/ml 32 Mitoxantrone HCI, 2 mg/ml 33 Oxaliplatin, 2 mg/ml 34 Pacilitaxel, 6 mg/ml 35 Retrovir, 10 mg/ml 36 ThioTEPA, 10 mg/ml 37 Trisonex, 1 mg/ml 38 Vidaza(Azacitidine),25 mg/ml 39 Vincristine Sulfate,1 mg/ml Fentanyl, Gastric Acid and Xylazine 1 Fentanyl Citrate Injection,50mcg/ml 2 Gastric Acid 3 Fentanyl Citrate: Xylazine HCL, 50:50 *Please note that the following drugs have extremely low permeation times: Carmustine: 11.0 minutes, Thio Tepa:26.0 minutes Warning: Do not use with Carmustine and Thiotepa.

Source page: https://510kreport.com/device/K250193
Methodology: https://510kreport.com/methodology