# K983207: Synthetic Powder-Free Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Great Eagle Plastic Products Co., Ltd.
- Decided: Oct 30, 1998 after 46 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 K942042 (1994). 2 ancestors in all.
8 later devices descend from it; 6 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964964: Powder-Free Vinyl Patient Examination Gloves, Sunmax Enterprise Shanghai Co., Ltd. (1997) Summary page 1.
- K942042: Powder Free Vinyl Patient Examination Gloves, Cheer & Merit Co., Ltd. (1994) Summary page 1.

## Most influential descendants
- K092296: Powder Free Examination Glove (2009), 2 descendants of its own
- K102093: Powder Free Vinyl Patient Examination Gloves (2010), 0 descendants of its own
- K101137: Powder Free Vinyl Patient Examination Glove (2010), 0 descendants of its own
- K093798: Powder Free Vinyl Patient Examination Glove (2010), 0 descendants of its own
- K070037: Powder Free Vinyl Patient Examination Glove (2007), 0 descendants of its own

## Indications for use
A 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/K983207
Methodology: https://510kreport.com/methodology