# K994426: Glovetex, Latex Examination Gloves, Powdered Non-Sterile.(Protein Content Labeling)

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Wrp Buana Multicorpora
- Decided: May 23, 2000 after 145 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 its predicate without a number.
- (no number) Class I Latex Patient Examination Glove 80 LYY, protein content labeling: named in the summary without a submission number

## Indications for use
The Examination Glove is a medical glove which is disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between examiner and patient.

Source page: https://510kreport.com/device/K994426
Methodology: https://510kreport.com/methodology