# K973913: Medi-Plus, Health-Plus, Sanitex, Reliance

- Pathway: 510(k) (Traditional)
- Applicant: Pwa Industries Sdn. Bhd.
- Decided: Dec 18, 1997 after 65 days
- Product code: LYY (Latex 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 glove to be worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient, and to protect the healthcare worker from blood, body fluids and waste.

Source page: https://510kreport.com/device/K973913
Methodology: https://510kreport.com/methodology