# K151390: Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Maxter Glove Manufacturing Sdn Bhd
- Decided: May 2, 2016 after 342 days
- Product code: LZC (Medical Glove, Specialty)
- 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
Longest line of descent: 3 generations back to K042805 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141982: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs, Wrp Asia Pacific Sdn. Bhd. (2015) Summary page 4.

## 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 ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time (Minutes) Cisplatin, 1.0mg/ml >240 Cyclophosphamide (Cytoxan), 20mg/ml >240 Carmustine (BCNU), 3.3mg/ml 1.0 Dacarbazine (DTIC), 10.0mg/ml >240 Doxorubicin Hydrochloride, 2.0mg/ml >240 Etoposide (Toposar), 20.0mg/ml >240 Fluorouracil, 50.0mg/ml >240 Paclitaxel (Taxol), 6.0mg/ml >240 Thiotepa, 10.0mg/ml 31.3 Methotrexate ,25mg/ml >240 Mitomycin C, 0.5mg/ml >240 Vincristine Sulfate, 1.0mg/ml >240 Ifosfamide, 50.0mg/ml >240 Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml: 1.0 minute Thiotepa, 10.0mg/ml: 31.3 minutes

Source page: https://510kreport.com/device/K151390
Methodology: https://510kreport.com/methodology