# K220442: Synguard Nitrile Exam Glove

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Aoshang Outdoor Equipment Co., Ltd.
- Decided: May 12, 2022 after 85 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: 5 generations back to K062764 (2007). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172015: Powder Free Nitrile Examination Gloves, Blue (Colored), Careglove Global Sdn. Bhd. (2017) Summary page 5.

## Most influential descendants
- K253160: Syntex Exam Gloves (2026), 0 descendants of its own
- K232576: Medical Nitrile Examination Gloves (2023), 0 descendants of its own

## Indications for use
Synguard Nitrile Exam Glove is a disposable device intended for medical purposes that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K220442
Methodology: https://510kreport.com/methodology