# K231408: Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Intco Medical Products Co, Ltd.
- Decided: Aug 11, 2023 after 88 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: 4 generations back to K022548 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221169: JR MEDIC Nitrile Examination Gloves Powder Free- Black, Jr Engineering & Medical Technologies (M) Sdn. Bhd. (2022) Summary page 4.

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner' s hands or fingers to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K231408
Methodology: https://510kreport.com/methodology