# K091663: Powder-Free Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Zhangjiagang Fengyuan Plastic Products Co., Ltd.
- Decided: Jul 27, 2009 after 48 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: 2 generations back to K000071 (2000). 2 ancestors in all.
20 later devices descend from it; 18 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032908: Fuguan (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd. (2003) Summary page 1.

## Most influential descendants
- K110972: Powder Free Vinyl Patient Examination Gloves, Light Yellow Color (2011), 2 descendants of its own
- K211865: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (2021), 0 descendants of its own
- K210780: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (2021), 0 descendants of its own
- K210774: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (2021), 0 descendants of its own
- K191292: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (2019), 0 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/K091663
Methodology: https://510kreport.com/methodology