# K960746: Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Sunmax Enterprise Shanghai Co., Ltd.
- Decided: Jun 27, 1996 after 125 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 K893822 (1989). 2 ancestors in all.
61 later devices descend from it; 5 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K893822: Honyee Vinyl Examination Gloves, Honyee Enterprise Co. (1989) Summary page 1.
- K941809: Vinyl Patient Examination Gloves, Cheer & Merit Co., Ltd. (1995) Summary page 1.

## Most influential descendants
- 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
- K091662: Powdered Vinyl Patient Examination Gloves (2009), 6 descendants of its own

## Indications for use
A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient’s body, fluids, waste or environment.

Source page: https://510kreport.com/device/K960746
Methodology: https://510kreport.com/methodology