# K090194: Powder- Free Nitrile Examination Gloves, Black Color

- Pathway: 510(k) (Traditional)
- Applicant: Shen Wei (Usa), Inc.
- Decided: Jul 7, 2009 after 161 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices 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.

## Most influential descendants
- K120890: Powder-Free Nitrie Examination Gloves, Orange (2012), 2 descendants of its own
- K200150: Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) (2020), 1 descendant of its own
- K220825: Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves (2022), 0 descendants of its own
- K121528: Power-Free Nitrile Examination Gloves, Peppermint Scented, Blue Color (2012), 0 descendants of its own

## Indications for use
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is for over-the counter use.

Source page: https://510kreport.com/device/K090194
Methodology: https://510kreport.com/methodology