# K011198: Senicare Advantix Powder Free Polyurethane Medical Examination Glove, Sensicare Advantix Powder Free Polyurethane Dental

- Pathway: 510(k) (Traditional)
- Applicant: Maxxim Medical, Inc.
- Decided: May 17, 2001 after 28 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K031384: Multiple Private Labeled, Non-Sterile, Powder-Free, Polyurethane White Color, Examination Gloves (Intacta Polyurethane G (2003), 1 descendant of its own
- K213168: Medical Examination Gloves (2022), 0 descendants of its own
- K022095: Duraclean with Lycra Powder Free Polyurethane Medical Examination Glove (2002), 0 descendants of its own
- K021452: Sterile Sensicare Advantix Powder Free Polyurethane Medical/Dental Examination Glove (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K011198
Methodology: https://510kreport.com/methodology