# K113100: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Maxter Glove Manufacturing Sdn Bhd
- Decided: Feb 6, 2012 after 110 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 patient 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drug and Concentration — Minimum Breakthrough Detection Time (Minutes) Cisplatin, 1.0 mg/ml (1,000 ppm) — >240 Cyclophosphamide (Cytoxan), 20 mg/ml (20,000 ppm) — >240 Carmustine (BCNU), 3.3 mg/ml (3,300 ppm) — 0.53 Dacarbazine (DTIC), 10.0 mg/ml (10,000 ppm) — >240 Doxorubicin Hydrochloride, 2.0 mg/ml (2,000 ppm) — >240 Etoposide (Toposar), 20.0 mg/ml (20,000 ppm) — >240 Fluorouracil, 50.0 mg/ml (50,000 ppm) — >240 Paclitaxel (Taxol), 6.0 mg/ml (6,000 ppm) — >240 Thiotepa, 10.0 mg/ml (10,000 ppm) — 175.54 Please note that the following drugs have low permeation time of less than 240 minutes: *Carmustine (BCNU), 3.3 mg/ml (3,300 ppm) Thiotepa, 10.0 mg/ml (10,000 ppm)

Source page: https://510kreport.com/device/K113100
Methodology: https://510kreport.com/methodology