# K071740: Chlorinated Powder Free Nitrile Latex Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Medtexx Manufacturing Sdn. Bhd.
- Decided: Oct 4, 2007 after 99 days
- Product code: LZA (Polymer 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 1 Patient Examination glove bearing the product code BOLZA: named in the summary without a submission number

## Indications for use
Blue Colour, Chlorinated Powder Free Nitrile Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Source page: https://510kreport.com/device/K071740
Methodology: https://510kreport.com/methodology