# K163553: Powder Free Nitrile Patient Examination Gloves, Blue

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Titans Medical Supply Technology Group., Ltd.
- Decided: May 22, 2017 after 154 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 K993247 (1999). 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)
- K131440: Powder Free Nitrile Patient Examination Gloves, Blue, Hebei Hongsen Plastics Technology Co, Ltd. (2013) Summary page 5.

## Indications for use
The powder free nitrile patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K163553
Methodology: https://510kreport.com/methodology