# K150103: Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Hartalega Sdn Bhd
- Decided: Apr 23, 2015 after 93 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 Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs is a non-sterile disposable device intended for medical and dental purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) as per attached table. Please note that Carmustine and Thiotepa have extremely low permeation times of 45.4 minutes and 30.9 minutes, respectively.

Source page: https://510kreport.com/device/K150103
Methodology: https://510kreport.com/methodology