# K101293: Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Smartglove Indonesia
- Decided: Jul 1, 2010 after 52 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
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs. Chemotherapy Drugs Permeation (Breakthrough detection time in minutes) Carmustine (BCNU) (3.3 mg / ml) 1.21 Thiotepa (10.0 mg I ml) 90.7 Fluorouracil (50.0 mg I ml) > 240 Etoposide (Toposar) (20.0 mg /ml) > 240 Cyclophospharnide (Cytoxan) (20.0 mg Imt) > 240 Mitomycin C (0.5 mg I ml) > 240 Methotrexate (25.0 mg / ml) >240 Paclitaxel (Taxol) (6.0 mg I mt) > 240 Doxorubicin Hydrochloride (2.0 mg / ml) > 240 Dacarbazine (DTIC) (10.0 mg / ml) > 240 Cisplatin (1.0 mg I ml) > 240 Mitoxantrone (2.0 mg I ml) > 240 Ifosfamide (50.0 mg I ml) > 240 Vincristine Sulfate (1.0mg I ml) > 240 Warning: Do Not Use with Carmustine

Source page: https://510kreport.com/device/K101293
Methodology: https://510kreport.com/methodology