# K021452: Sterile Sensicare Advantix Powder Free Polyurethane Medical/Dental Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Maxxim Medical
- Decided: Aug 1, 2002 after 87 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: 1 generation back to K011198 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011198: Senicare Advantix Powder Free Polyurethane Medical Examination Glove, Sensicare Advantix Powder Free Polyurethane Dental, Maxxim Medical, Inc. (2001) Summary page 1.

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

Source page: https://510kreport.com/device/K021452
Methodology: https://510kreport.com/methodology