# K140816: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Better Care Plastic Technology Co., Ltd.
- Decided: Jul 8, 2014 after 98 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
Longest line of descent: 2 generations back to K093726 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102096: Powder Free Nitrile Examination Gloves, Blue, Syntex Healthcare Products Co., Ltd. (2010) Summary page 1.

## Indications for use
A patient examination glove is disposable non-sterile device intended for medical purpose 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 times are as follows: Test Chemotherapy Drug and Concentration Average BDT Fluorouracil, 50.0mg/mi (50.OO0ppm) >240 min. Etoposide (Toposar), 20.0mg/mI (20,OO0ppm) >240 min. Cyclophosphamide (Cytoxan), 20mg/mi (20,OO0ppm) >240 min. Carmustine (BCNU), 3.3mg/mi (3,300ppm) 2.3 min. Thiotepa. 10.0mg/mil (I0,OO0ppm) 30.9 min. Paclitaxel (Taxol), 6.0mg/mil (6,OO0ppm) >240 mmi. Doxorubicin Hydrochloride, 2.0mg/mI (2,OO0ppm) >240 min. Dacarbazine (DTiC), I10.0mg/mI (I10,OO0ppm) >240 min. Cisplatin, 1.0mg/mi (l,OO0ppm) >240 min. Please note that Carmustine and Thiotepa have extremely lowv permeation times of 2,3 minutes and 30.9 minutes, respectively.

Source page: https://510kreport.com/device/K140816
Methodology: https://510kreport.com/methodology