# K011882: Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Eversharp Plastic Products Co., Ltd.
- Decided: Jul 10, 2001 after 22 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 K992861 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992861: Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves, Shijiazhuang Great Eagle Plastic Products Co., Ltd. (1999) Summary page 1.

## Most influential descendants
- K132201: Synmax Synthetic Examination Vinyl Gloves, Powder Free, Blue Color (2013), 0 descendants of its own

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

Source page: https://510kreport.com/device/K011882
Methodology: https://510kreport.com/methodology