# K984461: Pre-Powder 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: 3 generations back to K893822 (1989). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974151: Vinyl Patient Examination Gloves (Powdered), Shanghai Super Gloves Co., Ltd. (1997) Summary page 1.

## Most influential descendants
- K993859: Shanghai Glovmax Enterprise CO., LTD. Pre-Powdered Vinyl Patient Examination Gloves (2000), 0 descendants of its own
- K992205: Pre-Powdered 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/K984461
Methodology: https://510kreport.com/methodology