# K941809: Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Cheer & Merit Co., Ltd.
- Decided: Jul 20, 1995 after 464 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.
62 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K960746: Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. Gloves (1996), 61 descendants of its own
- K974151: Vinyl Patient Examination Gloves (Powdered) (1997), 60 descendants of its own
- K983645: Synthetic Powdered Vinyl Patient Examination Gloves (1998), 51 descendants of its own
- 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

Source page: https://510kreport.com/device/K941809
Methodology: https://510kreport.com/methodology