# K994255: Latex Examination Gloves-Pre-Powdered-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Maja Agung Latexindo
- Decided: Feb 7, 2000 after 52 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 Examination Gloves 80 LYY Pre-Powdered meeting ASTM D 35678-95: named in the summary without a submission number

## Indications for use
A latex examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners that require a sterile procedure.

Source page: https://510kreport.com/device/K994255
Methodology: https://510kreport.com/methodology