# K032908: Fuguan (Brand) Powder-Free Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Fuguan Plastic Products Co., Ltd.
- Decided: Nov 20, 2003 after 64 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: 1 generation back to K000071 (2000). 1 ancestor in all.
130 later devices descend from it; 75 cite it directly.
0 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000071: Synthetic Powder Free (White) Vinyl Patient Examination Gloves, Shijiazhuang Great Eagle Plastic Products Co., Ltd. (2000)

## Most influential descendants
- K091663: Powder-Free Vinyl Patient Examination Gloves (2009), 20 descendants of its own
- K120968: Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored) (2012), 19 descendants of its own
- K100699: Powder-Free Vinyl Patient Examination Gloves (2010), 9 descendants of its own
- K130733: Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored) (2014), 5 descendants of its own
- K142703: Powder-free PVC Vinyl Exam Gloves (2015), 4 descendants of its own

## Indications for use
Powder free vinyl patient examination glove is a 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/K032908
Methodology: https://510kreport.com/methodology