# K101135: Powder Free Vinyl Patient Examination Gloves (Yellow, White,Blue, Pink)

- Pathway: 510(k) (Traditional)
- Applicant: Hongze Plastic Technology Co., Ltd.
- Decided: Jul 1, 2010 after 70 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: 2 generations back to K992861 (1999). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092301: Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink), Bettercare Plastic Products Co., Ltd. (2009) Summary page 1.

## Most influential descendants
- K142570: Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink ) (2014), 1 descendant of its own
- K180260: Powder Free Vinyl Patient Examination Gloves (Yellow, White) (2018), 0 descendants of its own

## Indications for use
A patient examination glove is disposable device intended for medical purpose that is worn on. the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K101135
Methodology: https://510kreport.com/methodology