# K130038: Powder-Free Nitrile Examination Gloves, Blue

- Pathway: 510(k) (Traditional)
- Applicant: Hl Rubber Industries Sdn Bhd
- Decided: Feb 21, 2013 after 45 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examinees hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy

Source page: https://510kreport.com/device/K130038
Methodology: https://510kreport.com/methodology