# K032016: Dermagrip-X Powder Free Latex Examination Gloves Coated with Alpha Lipoic Acid and Vitamin E, and with Protein Content

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Specialty Products Sdn. Bhd.
- Decided: May 11, 2004 after 316 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. The FDA summary names no predicate by number.

## Indications for use
The patient examination glove is a disposable device and is made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K032016
Methodology: https://510kreport.com/methodology