# K984460: Powder-Free Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Huamao Gloves Co., Ltd.
- Decided: Feb 9, 1999 after 55 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: 2 generations back to K942042 (1994). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974120: Powder-Free Vinyl Patient Examination Gloves, Shanghai Super Gloves Co., Ltd. (1997) Summary page 1.

## Most influential descendants
- K993880: Shanghai Glovmax Enterprise CO, LTD., Powder-Free Vinyl Patient Examination Gloves (2000), 0 descendants of its own
- K992206: Powder-Free Vinyl Patient Examination Gloves (1999), 0 descendants 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/K984460
Methodology: https://510kreport.com/methodology