# K072197: Powder-Free Latex Examination Gloves - 18 Mils at Finger, Blue Color; 9 and 10 Mils at Finger, Natural Color

- Pathway: 510(k) (Traditional)
- Applicant: Metacure Surgical Gloves Sdn Bhd
- Decided: Mar 12, 2008 after 218 days
- Product code: LZC (Medical Glove, Specialty)
- 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 patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Gloves that have been tested for use with chemotherapy drugs are not intended to be used as a chemical barrier.

Source page: https://510kreport.com/device/K072197
Methodology: https://510kreport.com/methodology