# K014087: Latexx Manufacturing Non-Chlorinated, Polymer Coated, Powder-Free Rubber Latex Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Latexx Manufacturing Sdn.Bhd.
- Decided: Mar 4, 2002 after 83 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
Non-chlorinated Power Free Natural Rubber Examination Glove is a single use device intended for medical purposes that is worn on the hand of the healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Source page: https://510kreport.com/device/K014087
Methodology: https://510kreport.com/methodology