# K051662: Vinyl Nitrile CO-Polymer Powder Free Exam Gloves (Blue Color)

- Pathway: 510(k) (Traditional)
- Applicant: Grand Work Plastic Products Co., Ltd.
- Decided: Jul 22, 2005 after 30 days
- Product code: LZA (Polymer 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
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K011882: Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves, Shijiazhuang Eversharp Plastic Products Co., Ltd. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K153028: Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue (2016), 10 descendants of its own
- K211262: Disposable Vinyl Nitrile Synthetic Gloves Powder Free (2021), 1 descendant of its own
- K213574: Nitrile Vinyl Blend Powder Free Examination Gloves (Black) (2022), 0 descendants of its own
- K213634: Vinyl/Nitrile Blend Exam Glove (2022), 0 descendants of its own
- K212436: NBR Synthetic Nitrile Examination Gloves (2021), 0 descendants of its own

## Indications for use
The Vinyl Plastic Co-Polymer Powder-Free Examination Gloves (Blue Color) is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K051662
Methodology: https://510kreport.com/methodology
