# K991686: Latex Examination Gloves, Powder Free with Protein Labeling Claim (50 MCG or Less)

- Pathway: 510(k) (Traditional)
- Applicant: Arista Latindo Industrial Ltd. P.T
- Decided: Jun 11, 1999 after 25 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
Longest line of descent: 1 generation back to K921389 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921389: Powderfree Natural Latex Gloves, Arista Latindo Industrial Ltd. P.T (1993) Summary page 3.

## Indications for use
A patient 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 examiner.

Source page: https://510kreport.com/device/K991686
Methodology: https://510kreport.com/methodology