# K964964: Powder-Free Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Sunmax Enterprise Shanghai Co., Ltd.
- Decided: Feb 7, 1997 after 58 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.
36 later devices descend from it; 5 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K992821: Synthetic Powder-Free Vinyl Patient Examination Gloves (2000), 18 descendants of its own
- K983207: Synthetic Powder-Free Vinyl Patient Examination Gloves (1998), 8 descendants of its own
- K974120: Powder-Free Vinyl Patient Examination Gloves (1997), 4 descendants of its own
- K092296: Powder Free Examination Glove (2009), 2 descendants of its own
- K984460: Powder-Free Vinyl Patient Examination Gloves (1999), 2 descendants of its own

Source page: https://510kreport.com/device/K964964
Methodology: https://510kreport.com/methodology