# K121592: Powder Free Blue Nitrile Examination Glove Tested with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Tekmedic (M) Sdn Bhd
- Decided: Jan 18, 2013 after 232 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 powder free nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs and their breakthrough detection time are as follows: Chemotherapy Drugs & concentration Average Breakthrough Detection Time Carmustine (BCNU), 3300ppm. 60.2 Cisplatin, IOO0ppm > 240 min Cycaophosphamide (Cytoxan), 20,000 ppm > 240 min Dacarbazine (DTIC), 10,000 ppm > 240 min Doxomubicin Hydrochloride, 2000 ppm > 240 min Etoposide (Toposar), 20,000 ppm > 240 min Fluorouracil, 50,000 ppm > 240 min Ifosfami~de, 50,000 ppm > 240 win Methotrexate, 25,000 ppm > 240 min Mitomycin C, 500 ppm > 240 min Mitoxantrane, 2000 ppm > 240 min Paclitaxel (Taxol), 6000 ppm > 240 win Thiothepa, 10,000 ppm 105.6 Vincristine Sulfate, 1000 ppm >240 min Please note that the following drugs have low permeation times: Carnrnstine - 60.2 minutes Thiothepa - 105.6 minutes

Source page: https://510kreport.com/device/K121592
Methodology: https://510kreport.com/methodology