# K082302: Powder Free Nitrile Patient Examination Gloves with Chemo Labeling Claim

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Medisafe Technologies
- Decided: Dec 9, 2008 after 119 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 device is a disposable examination glove made of synthetic rubber intended for medical purposes and is donned by the user on the hands to prevent possible contamination between patient and examiner or when handling cytotoxic drugs listed below:. 1. Carmustine (BiCNU); 2. Cyclophosphamide; 3. Doxorubicin Hydrochloride; 4. 5-Fluorouracil; 5. Cisplatin; 6. Etoposide; 7. Paclitaxel; 8. Thio-Tepa 9. Dacarbazine

Source page: https://510kreport.com/device/K082302
Methodology: https://510kreport.com/methodology