# K171737: Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Healthcare Products, LLC
- Decided: Dec 29, 2017 after 200 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: 3 generations back to K062764 (2007). 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)
- K123469: Powder Free Nitrile Patient Examination Glove, Blue and White Colored, Non-Sterile, Wear Safe (Malaysia) Sdn Bhd - Facility II (2013) Summary page 4.

## Indications for use
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves are intended for medical purposes that are worn on the examiners hands to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K171737
Methodology: https://510kreport.com/methodology