# K110418: Powder Free Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: W.A. Rubbermate Co., Ltd.
- Decided: Jul 13, 2011 after 149 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. The FDA summary names its predicate without a number.
- (no number) Class 1 Patient Examination glove bearing product code LZA: named in the summary without a submission number

## Indications for use
Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is intended to be worn on the hand for medical purpose to provide barrier against potentially infectious materials and other contaminants.

Source page: https://510kreport.com/device/K110418
Methodology: https://510kreport.com/methodology