# K220155: Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Motex Healthcare (Anhui) Co., Ltd.
- Decided: May 23, 2022 after 124 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
A patient examination 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 have been tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug Permeation: Chemotherapy Drugs Tested — Breakthrough Time Bleomycin Sulfate, 15 mg/mI (15,000 ppm) — >240 minutes Bortezomib (Velcade), I mg/mi (1,000ppm) — >240 minutes Busulfan, 6 mg/mI (6,000 ppm) — >240 minutes Carboplatin, 10 mg/mI (10,000 ppm) — >240 minutes Carmustine (BCNU), 3.3 mg/mI (3,300 ppm) — 45 4 minutes* Chloroquine, 50 mg/nil (50,000 ppm) — >240 minutes Cisplatin, 1.0 mg/mI (1,000 ppm) — >240 minutes Cyclophosphamide (Cytoxan), 20.0 mg/mI (20,000 ppm) — >240 minutes Cytarabine, 100 mg/ml (100,000 ppm) — >240 minutes Dacarbazine, 10.0 mg/mi (10,000 ppm) — >240 minutes Daunorubicin HCI, 5 mg/mI (5,000 ppm) — >240 minutes Docetaxel. 10 mg/mI (10,000 ppm) — >240 minutes Etoposide, 20.0 mglml (20,000 ppm) — >240 minutes Fluorouracil, 50 0 mg/mI (50,000 ppm) — >240 minutes Gemcitabine, 38 mg/ml (38,000 ppm) — >240 minutes Idarubicin HCI, 1 mg/ml (1,000 ppm) — >240 minutes Ifosfamide, 50 mg/ml (50,000 ppm) — >240 minutes Irinotecan, 20 mg/ml (20,000 ppm) — >240 minutes Mechlorethamine HCI, I mg/ml (1,000 ppm) — >240 minutes Melphalan, 5 mg/mI (5,000 ppm) — >240 minutes Methotrexate, 25 mg/ml (25,000ppm) — >240 minutes Mitomycin C, 0.5 mg/ml (500 ppm) — >240 minutes Mitoxantrone, 2 mg/mI (2,000 ppm) — >240 minutes Paclitaxel, 6.0 mg/ml (6,000 ppm) — >240 minutes ThioTepa, 10.0 mg/mI (10,000 ppm) — 15.6 minutes* Triclosan, 2 mg/mI (2,000 ppm) — >240 minutes Trisenox, I mg/ml (1,000 ppm) — >240 minutes Vincristine Sulfate, 1 0 mg/ml (1,000 ppm) — >240 minutes *WARNING Not recommended for use with Carmustine and ThioTepa. The maximum testing time is 240 minutes. Please note that the following drugs have low permeation times: Carmustine (BCNU), 3.3 mg/mI (3,300 ppm) — 45.4 minutes ThioTepa, 10.0 mg/ml (10,000 ppm) — 15.6 minutes

Source page: https://510kreport.com/device/K220155
Methodology: https://510kreport.com/methodology