# K120968: Power-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)

- Pathway: 510(k) (Traditional)
- Applicant: Tangshan Zhonghong Pulin Plastic Co.,Ltd
- Decided: Sep 19, 2012 after 173 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.
19 later devices descend from it; 14 cite it directly.
0 of 22 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.

## Most influential descendants
- K130733: Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored) (2014), 5 descendants of its own
- K142703: Powder-free PVC Vinyl Exam Gloves (2015), 4 descendants of its own
- K173078: Powder-free Clear Vinyl Patient Examination Gloves (2018), 0 descendants of its own
- K171317: Clear Vinyl Powder-free Patient Examination Gloves (2017), 0 descendants of its own
- K170735: Powder-Free Clear Vinyl Patient Examination Gloves (2017), 0 descendants of its own

## Recalls of this device
- Oct 12, 2016 · Class II · Z-0741-2017: A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.

## Indications for use
Powder free vinyi 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/K120968
Methodology: https://510kreport.com/methodology