# K992205: Pre-Powdered Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai China Star Corp
- Decided: Jul 23, 1999 after 23 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: 4 generations back to K893822 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984461: Pre-Powder Vinyl Patient Examination Gloves, Shanghai Huamao Gloves Co., Ltd. (1999) Summary page 1.
- (no number) Shanghai Super Gloves Co., Ltd. Pre-powdered 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/K992205
Methodology: https://510kreport.com/methodology