# K972169: Medi-Plus, Health-Plus, Sanitex, Reliance

- Pathway: 510(k) (Traditional)
- Applicant: Pwa Industries Sdn. Bhd.
- Decided: Oct 3, 1997 after 116 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 glove is worn on the hand of health care worker and similar personnel to prevent contamination between the health care personnel and the patient, or environment.

Source page: https://510kreport.com/device/K972169
Methodology: https://510kreport.com/methodology