# K121368: Nitrile Examination Glove, Powder Free (Blue, Black or White)

- Pathway: 510(k) (Traditional)
- Applicant: Matang Mfg. Sdn. Bhd.
- Decided: Aug 10, 2012 after 95 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 Colored Nitrile Examination Glove - Powder Free (Blue. Black and White) is a disposable device made of Nitrite latex that may bear a trace amount of glove powder and is intended to be worn on the bands or finger(s) for medical purposes to provide a ban-ier against potentially infectious materials and other contaminants. A colors blue, black and white will be added to the nitrite examination glove in the production process to produce the colored gloves.

Source page: https://510kreport.com/device/K121368
Methodology: https://510kreport.com/methodology