# K011884: Powdered Synthetic Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Eversharp Plastic Products Co., Ltd.
- Decided: Jul 17, 2001 after 29 days
- Product code: LYZ (Vinyl 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
Longest line of descent: 4 generations back to K893822 (1989). 5 ancestors in all.
40 later devices descend from it; 2 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983645: Synthetic Powdered Vinyl Patient Examination Gloves, Shijiazhuang Great Eagle Plastic Products Co., Ltd. (1998) Summary page 1.

## Most influential descendants
- K032907: Fuguan (Brand) Powdered Vinyl Patient Examination Gloves (2003), 38 descendants of its own
- K091662: Powdered Vinyl Patient Examination Gloves (2009), 6 descendants of its own
- K070075: Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored) (2007), 2 descendants of its own
- K081657: Powdered Vinyl Patient Examination Gloves, (Light Yellow) (2008), 1 descendant of its own
- K042120: Powdered Vinyl Patient Examination Gloves (2004), 1 descendant of its own

## Indications for use
A patient examination glove is disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K011884
Methodology: https://510kreport.com/methodology