# K983645: Synthetic Powdered Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Great Eagle Plastic Products Co., Ltd.
- Decided: Dec 4, 1998 after 49 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: 3 generations back to K893822 (1989). 4 ancestors in all.
51 later devices descend from it; 6 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960746: Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. Gloves, Sunmax Enterprise Shanghai Co., Ltd. (1996) Summary page 1.
- K974151: Vinyl Patient Examination Gloves (Powdered), Shanghai Super Gloves Co., Ltd. (1997) Summary page 1.

## Most influential descendants
- K011884: Powdered Synthetic Vinyl Patient Examination Gloves (2001), 40 descendants of its own
- 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
- K992862: Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves (1999), 5 descendants of its own
- K070075: Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored) (2007), 2 descendants of its own

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

Source page: https://510kreport.com/device/K983645
Methodology: https://510kreport.com/methodology