# K031580: Non-Sterile, Powder-Free, Blue Color Nitrile Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Green Prospect Sdn Bhd
- Decided: Jul 25, 2003 after 66 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 I Patient Examination Glove 80 MA, powder free: named in the summary without a submission number

## Most influential descendants
- K093523: Micro-Touch Nitrile (2010), 0 descendants of its own

## Indications for use
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Source page: https://510kreport.com/device/K031580
Methodology: https://510kreport.com/methodology