# K992797: Synthetic Powdered Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Hongxiang Plastics Products Co., Ltd.
- Decided: Nov 5, 1999 after 78 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.
No later device cites it as a predicate yet.
0 of 5 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.

## Indications for use
A patient examination glove is 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/K992797
Methodology: https://510kreport.com/methodology