# K993793: Guthrie Prime Pre-Powdered Patient Latex Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Guthrie Medicare Products (Melaka) Sdn Bhd
- Decided: Jan 12, 2000 after 64 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
Patient Examination Glove is a disposable device which is primarily intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner, These gloves are STRICTLY NOT intended for surgical use or as a substitute for surgery puposes.

Source page: https://510kreport.com/device/K993793
Methodology: https://510kreport.com/methodology