# K031386: Lalan Gloves (PVT) LTD Glove, Patient Examination, Latex

- Pathway: 510(k) (Traditional)
- Applicant: Lalan Gloves (Pvt), Ltd.
- Decided: Oct 6, 2003 after 158 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
A POWDER FREE PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE MADE OF NATURAL RUBBER LATEX OR SYNTHETIC MATERIAL THAT MAY BEAR A TRACE AMOUNT OF GLOVE POWDER IS INTENDED TO BE WORN ON THE HAND OR FINGER (S) FOR MEDICAL PURPOSE TO PROVIDE A BARRIER AGAINST POTENTIALLY INFECTIOUS MATERIAL AND OTHER CONTAMINANTS.

Source page: https://510kreport.com/device/K031386
Methodology: https://510kreport.com/methodology