# K102152: Powder-Free Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Tengda Plastic Co., Ltd.
- Decided: Apr 28, 2011 after 272 days
- Product code: LYZ (Vinyl Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000071 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032908: Fuguan (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd. (2003) Summary page 1.

## Recalls of this device
- Jun 20, 2012 · Class II · Z-0295-2013: Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale.

## Indications for use
Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's band or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K102152
Methodology: https://510kreport.com/methodology