# K141305: Richful Powder-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Richful Plastic Co., Ltd.
- Decided: Aug 27, 2014 after 100 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 K000071 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120968: Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored), Tangshan Zhonghong Pulin Plastic Co.,Ltd (2012) Summary page 4.

## Indications for use
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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/K141305
Methodology: https://510kreport.com/methodology