# K213548: Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy

- Pathway: 510(k) (Traditional)
- Applicant: Mercator Medical (Thailand), Ltd.
- Decided: Feb 21, 2022 after 105 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
Nitrylex® Classic Powder Free Nitrile Blue Examination Gloves Tested for use with Chemotherapy Drugs are disposable devices intended for medical propose that are worn on the examiner’s hands to prevent contamination between patent and examiner. The proposed device was tested for use with Chemotherapy Drugs as per ASTM D678-05 Standard Practice for Assessment Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drugs Permeation. The following chemicals have been tested with the proposed device. Test Chemotherapy Drugs — Concentration — Breakthrough Detection (Time In Minutes) Bleomycin Sulfatte — 15 mg/ml (15,000 ppm) — >240 min. Busulfan — 6 mg/ml (6,000 ppm) — >240 min. Carboplatin — 10 mg/ml (10,000 ppm) — >240 min. Cisplatin — 1 mg/ml (1,000 ppm) — >240 min. Cyclophosphamide (Cytoxan) — 20.0 mg/ml (20,000 ppm) — >240 min. Cytarabine HCl — 100 mg/ml (100,000 ppm) — >240 min. Cytovene — 10 mg/ml (10,000 ppm) — >240 min. Dacarbazine — 10 mg/ml (10,000 ppm) — >240 min. Daunorubicin HCl — 5 mg/ml (5,000 ppm) — >240 min. Docetaxel — 10 mg/ml (10,000 ppm) — >240 min. Doxorubicin HCl — 2.0 mg/ml (2,000 ppm) — >240 min. Epirubicin HCl — 2 mg/ml (2,000 ppm) — >240 min. Etoposide — 20.0 mg/ml (20,000 ppm) — >240 min. Fludarabine — 25 mg/ml (25,000 ppm) — >240 min. Fluorouracil — 50.0 mg/ml (50,000 ppm) — >240 min. Gemcitabine — 38 mg/ml (38,000 ppm) — >240 min. Idarubicin HCl — 1 mg/ml (1,000 ppm) — >240 min. Ifosfamide — 50 mg/ml (50,000 ppm) — >240 min. Irinotecan — 20 mg/ml (20,000 ppm) — >240 min. Mechlorethamine HCl — 1 mg/ml (1,000 ppm) — >240 min. Melphalan — 5 mg/ml (5,000 ppm) — >240 min. Methotrexate — 25 mg/ml (25,000 ppm) — >240 min. Mitomycin C — 0.5 mg/ml (500 ppm) — >240 min. Mitoxantrone — 2 mg/ml (2,000 ppm) — >240 min. Oxaliplatin — 2 mg/ml (2,000 ppm) — >240 min. Paclitaxel — 6.0 mg/ml (6,000 ppm) — >240 min. Rituximab — 10 mg/ml (10,000 ppm) — >240 min. Trisenox — 1 mg/ml (1,000 ppm) — >240 min. Vincristine Sulfate — 1 mg/ml (1,000 ppm) — >240 min. Vinorelbine — 10 mg/ml (10,000 ppm) — >240 min. Fentanyl Citrate Injection — 100 mcg/2 ml — >240 min. Carmustine (BCNU) — 3.3 mg/ml (3,300 ppm) — 34.8 (39.4, 38.7, 34.8) ThioTepa — 10.0 mg/ml (10,000 ppm) — 47.4 (48.2, 50.0, 47.4) Please note that the following drugs showed break through detected in less than 240 minutes: - Carmustine (BCNU), 3.3 mg/ml: 34.8 minutes - Thiotepa (THT) 10.0 mg/ml: 47.4 minutes Warning-Not for Use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K213548
Methodology: https://510kreport.com/methodology