# K992206: Powder-Free Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai China Star Corp
- Decided: Jul 29, 1999 after 29 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 K942042 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984460: Powder-Free Vinyl Patient Examination Gloves, Shanghai Huamao Gloves Co., Ltd. (1999) Summary page 1.
- (no number) Shanghai Super Gloves Co., Ltd. Powder-free vinyl patient examination gloves: named in the summary without a submission number

## 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/K992206
Methodology: https://510kreport.com/methodology