# K213373: Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Smart Glove Corporation Sdn. Bhd.
- Decided: Mar 10, 2022 after 149 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 Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and 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. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate. The gloves were tested with chemotherapy drugs and fentanyl citrate as per ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Test drug and concentration Average Breakthrough Detection Time (mins) Carmustine (BCNU), 3.3 mg/ml (3,300 ppm) 13.5 Cisplatin, 1.0 mg/ml (1,000 ppm) > 240 Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm) > 240 Dacarbazine, 10.0 mg/ml (10,000 ppm) > 240 Doxorubicin HCL, 2.0 mg/ml (2,000 ppm) > 240 Etoposide, 20.0 mg/ml (20,000 ppm) > 240 Fluorouracil, 50.0 mg/ml (50,000 ppm) > 240 Ifosfamide, 50.0 mg/ml (50,000 ppm) > 240 Methotrexate, 25.0 mg/ml (25,000 ppm) > 240 Mitomycin, 0.5 mg/ml (500 ppm) > 240 Mitoxantrone, 2.0 mg/ml (2,000 ppm) > 240 Paclitaxel, 6.0 mg/ml (6,000 ppm) > 240 ThioTepa, 10.0 mg/ml (10,000 ppm) 19.0 Vincristine Sulfate, 1.0 mg/ml (1,000 ppm) > 240 CAUTION: Do not use with Carmustine and ThioTepa. Fentanyl Citrate Concentration Minimum Breakthrough Detection Time (mins) Fentanyl Citrate Injection, 100 mcg/2ml > 240

Source page: https://510kreport.com/device/K213373
Methodology: https://510kreport.com/methodology