# K042247: Synthetic (Blue) Vinyl Patient Examination Gloves - Powder Free

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Hongxiang Plastics Products Co., Ltd.
- Decided: Sep 2, 2004 after 14 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 K001834 (2000). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001834: Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves, Shijiazhuang Hongxiang Plastics Products Co;, Ltd. (2000)

## Most influential descendants
- K061562: Vinyl CO-Polymer Powder Free Examination Gloves, Blue Color (2006), 4 descendants of its own
- K142409: Vinyl Co-Polymer Powder Free Examination Gloves (2014), 1 descendant of its own
- K220240: Vinyl Co-Polymer Powder-free Examination Gloves, Black (2022), 0 descendants of its own
- K092294: Vinyl CO-Polmer Free Examination Gloves, Blue Color (2009), 0 descendants of its own
- K070852: Vinyl CO-Polymer Powder Free Examination Gloves, Blue Color (2007), 0 descendants of its own

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

Source page: https://510kreport.com/device/K042247
Methodology: https://510kreport.com/methodology