# K991677: Regent Skindende Exam Glove, Regent Biogel D, Regentbiogel Diagnostic (Powderfree)

- Pathway: 510(k) (Traditional)
- Applicant: London International Group, Inc.
- Decided: Apr 12, 2000 after 331 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
“An examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between the patient and examiner.” In addition, the glove is suitable for oncology use.

Source page: https://510kreport.com/device/K991677
Methodology: https://510kreport.com/methodology