# K090828: Non-Sterile, Powder Free Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Ultrawin Sdn Bhd
- Decided: Jul 28, 2009 after 124 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.
5 later devices descend from it; 5 cite it directly.
0 of 6 devices 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 I patient examination glove (product code LZA): named in the summary without a submission number

## Most influential descendants
- K101870: Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination Glove (2010), 1 descendant of its own
- K103675: Chienmax Vietnam CO. LTD Powder Free Blue Nitrile Examination Glove (2011), 0 descendants of its own
- K110960: Royal Imperial Nitrile Examination Gloves Textured Powder-Free (2011), 0 descendants of its own
- K093517: Nitritech or Multiple Private Label Non-Sterile Powder Free Nitrile Patient Examination Glove (2010), 0 descendants of its own
- K093516: Nitritech or Multiple Private Label Non Sterile Powdered Nitrile Examination Gloves (2010), 0 descendants of its own

## Indications for use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K090828
Methodology: https://510kreport.com/methodology