# K190876: mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed

- Pathway: 510(k) (Traditional)
- Applicant: Mercator Medical (Thailand), Ltd.
- Decided: Dec 2, 2019 after 242 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
mCare® Powder Free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05, The following drugs had no breakthrough detected up to 240 minutes 1. Cisplatin, 1.0 mg/ml 2. Cyclophosphamide (Cytoxan), 20 mg/ml 3. Dacarbazine (DTIC), 10.0 mg/ml 4. Doxorubicin Hydrochloride, 2.0 mg/ml 5. Etoposide (Toposar), 20.0 mg/ml 6. Fluorouracil, 50.0 mg/ml 7. Methotrexate, 25 mg/ml 8. Mitomycin C,0.5 mg/ml 9. Paclitaxel (Taxol), 6.0 mg/ml 10. Vincristine 1.0 mg/ml The following drugs showed breakthrough detected in less than 240 minutes: 1. Carmustine (BCNU), 3.3 mg/ml: 24.6 minutes 2. Thiotepa (THT) 10.0 mg/ml: 68.9 minutes Warning-Not for Use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K190876
Methodology: https://510kreport.com/methodology