# K162626: Thermoplastic Polyethylene Examination (Tpe) Glove

- Pathway: 510(k) (Traditional)
- Applicant: Top Quality Glove Sdn. Bhd
- Decided: Mar 31, 2017 after 192 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
Thermoplastic Polyethylene Examination (TPE) Glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner

Source page: https://510kreport.com/device/K162626
Methodology: https://510kreport.com/methodology