# K213168: Medical Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Huiwosheng Health Technology Co.,Ltd
- Decided: Jan 11, 2022 after 105 days
- Product code: LZA (Polymer 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 K011198 (2001). 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)
- K031384: Multiple Private Labeled, Non-Sterile, Powder-Free, Polyurethane White Color, Examination Gloves (Intacta Polyurethane G, Yty Industry (Manjung) Sdn Bhd (2003) Summary page 5.

## Indications for use
A medical glove is a disposable device intended for medical purposes that is worn on hand of the examiner’s hand to prevent contamination between the patient and the examiner.

Source page: https://510kreport.com/device/K213168
Methodology: https://510kreport.com/methodology