# K012048: Powder Free Neoprene Examination Gloves, Non Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Asia Pacific Sdn. Bhd.
- Decided: Aug 16, 2001 after 48 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 no predicate by number.

## Most influential descendants
- K022095: Duraclean with Lycra Powder Free Polyurethane Medical Examination Glove (2002), 0 descendants of its own

## Indications for use
The Powder Free Neoprene Examination Gloves, Non Sterile is a disposable device and is made of synthetic rubber intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K012048
Methodology: https://510kreport.com/methodology