# K992861: Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Great Eagle Plastic Products Co., Ltd.
- Decided: Oct 6, 1999 after 42 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
No predicates in its family tree.
16 later devices descend from it; 11 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K092301: Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink) (2009), 3 descendants of its own
- K101135: Powder Free Vinyl Patient Examination Gloves (Yellow, White,Blue, Pink) (2010), 2 descendants of its own
- K142570: Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink ) (2014), 1 descendant of its own
- K053523: Powder Free Sterile Vinyl Glove (Clear and Yellow) (2006), 1 descendant of its own
- K011882: Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves (2001), 1 descendant 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/K992861
Methodology: https://510kreport.com/methodology