# K211177: Powder Free Vinyl Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shijiazhuang Hongjun Plastic Manufacture Co., Ltd.
- Decided: Jul 17, 2021 after 88 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 K060778 (2006). 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)
- K180381: Powder Free Vinyl Patient Examination Gloves, Shanxi Hongjin Plastic Technology Co., Ltd. (2018) Summary page 4.

## Indications for use
Powder Free Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K211177
Methodology: https://510kreport.com/methodology