# K081655: Powder Free Vinyl Patient Examination Gloves (Light Yellow)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Cureguard Glove Co., Ltd.
- Decided: Jul 21, 2008 after 39 days
- Product code: LYZ (Vinyl Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K070076 (2007). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070076: Powder Free Vinyl Patinet Examination Gloves, Clear (Non-Colored), Jiangsu Cureguard Glove Co., Ltd. (2007) Summary page 1.

## Most influential descendants
- K093576: Rubber-Like Powder Free Vinyl Patient Examination  Gloves, White Color (2010), 0 descendants of its own

## Recalls of this device
- Feb 3, 2011 · Not classified · Z-1554-2011: The recall was initiated because the affected lot, lot number JCU004958569, of gloves did not meet the requirements for the water-leak test.
- Feb 3, 2011 · Not classified · Z-1553-2011: The recall was initiated because the affected lot, lot number JCU004958569, of gloves did not meet the requirements for the water-leak test.

## Indications for use
Powder free vinyl 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/K081655
Methodology: https://510kreport.com/methodology