# K243441: Nitrile Powder-Free Exam Gloves 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: Jan 31, 2025 after 86 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
Longest line of descent: 2 generations back to K223320 (2022). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240051: Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs, Lingshi Hongruida Health Protection Technology Co., Ltd. (2024) Summary page 7.

## Indications for use
The glove 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 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 Bendamustine HCI, 5 mg/ml Bortezomib, 1 mg/m Busulfan, 6 mg/mi Carboplatin, 10 mg/ml Carmustine, 3.3 mg/ml Carfilzomib, 2 mg/mi Cetuximab (Erbitux) 2 mg/ml Chloroquine, 50mg/ml Cisplatin, 1 mg/ml Cladribine, 1.0 mg/ml Cyclophosphamide, 20 mg/m Cyclosporin A,100mg/ml Cytarabine HCI, 100 mg/ml Cytovene, 10 mg/mi Dacarbazine, 10 mg/ml Daunorubicin HCI, 5 mg/mi Decitabine, 5 mg/ml Docetaxel, 10 mg/ml Doxorubicin HCI, 2 mg/ml Epirubicin HCI, 2 mg/mi Etoposide, 20 mg/ml Fludarabine, 25 mg/mi Fluorouracil, 50 mg/mi Gemcitabine HCI,, 38 mg/mi Idarubicin HCI,, 1 mg/ml Ifosfamide, 50 mg/ml Irinotecan, 20 mg/mi Mechlorethamine HCI, 1 mg/mli Melphalan HCI, 5 mg/mi Methotrexate, 25 mg/ml Mitomycin-C, 0.5 mg/mi Mitoxantrone HCI, 2 mg/ml Oxaliplatin, 2 mg/ml Paclitaxel, 6 mg/m Retrovir, 10 mg/ml ThioTEPA, 10 mg/mi Trisenox, 1 mg/ml Vidaza (Azacitidine),25 mg/ml Vincristine Sulfate,1 mg/mi Fentanyl Citrate and Gastric Acid Fentanyl Citrate Injection, 100mcg/2ml Simulated Gastric Acid *Please note that the following drugs have extremely low permeation times: Carmustine: 16.6 minutes, Thio Tepa: 44.9 minutes Warning: Do not use with Carmustine and Thio Tepa. Dark Blue glove: Chemotherapy Drugs Bendamustine HCI, 5 mg/mi Bortezomib, 1 mg/mi Busulfan, 6 mg/ml Carboplatin, 10 mg/ml Carmustine, 3.3 mg/ml Carfilzomib, 2 mg/mi Cetuximab (Erbitux) 2 mg/ml Chloroquine, 50mg/ml Cisplatin, 1 mg/ml Cladribine, 1.0 mg/ml Cyclophosphamide, 20 mg/mi Cyclosporin A,100mg/ml Cytarabine HCI, 100 mg/ml Cytovene, 10 mg/ml Dacarbazine, 10 mg/ml Daunorubicin HCI, 5 mg/mi Decitabine, 5 mg/ml Docetaxel, 10 mg/ml Doxorubicin HCI, 2 mg/ml Epirubicin HCI, 2 mg/mi Etoposide, 20 mg/ml Fludarabine, 25 mg/mi Fluorouracil, 50 mg/mi Gemcitabine HCI,, 38 mg/mi Idarubicin HCI,, 1 mg/ml Ifosfamide, 50 mg/ml Irinotecan, 20 mg/mi Mechlorethamine HCI, 1 mg/mi Melphalan HCI, 5 mg/ml Methotrexate, 25 mg/mi Mitomycin-C, 0.5 mg/ml Mitoxantrone HCI, 2 mg/ml Oxaliplatin, 2 mg/ml Paclitaxel, 6 mg/mi Retrovir, 10 mg/ml ThioTEPA, 10 mg/ml Trisenox, 1 mg/ml Vidaza (Azacitidine),25 mg/ml Vincristine Sulfate,1 mg/mi Fentanyl Citrate and Gastric Acid Fentanyl Citrate Injection, 100mcg/2ml Simulated Gastric Acid *Please note that the following drugs have extremely low permeation times: Carmustine: 21.5 minutes, Thio Tepa: 17.9 minutes Warning: Do not use with Carmustine and Thio Tepa.

Source page: https://510kreport.com/device/K243441
Methodology: https://510kreport.com/methodology