# K013303: Cleantexx Powderfree Synthetic Latex Examination Glove Made with Barrier-Pro Butadiene CO-Polmer

- Pathway: 510(k) (Traditional)
- Applicant: Latexx Manufacturing Sdn.Bhd.
- Decided: Jan 23, 2002 after 111 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) current Class I patient examination glove bearing product code 80LZA: named in the summary without a submission number

## Indications for use
Powder Free Synthetic Rubber Latex (BarrierPro™) 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/K013303
Methodology: https://510kreport.com/methodology