# K133699: Powder Free Green, Blue and Brown Polychloroprene Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Smartglove Indonesia
- Decided: Jul 18, 2014 after 227 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 no predicate by number.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that worn on the examiners hand or finger to prevent contamination between patient and examiner. A patient examination glove Is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. A patient examination glove is a disposable device intended for medical purposes that worn on the examiners hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K133699
Methodology: https://510kreport.com/methodology