# K010297: Sensicare Synthetic Powder Free Surgical Gloves (Poly Isoprene)

- Pathway: 510(k) (Special)
- Applicant: Maxxim Medical
- Decided: Feb 16, 2001 after 16 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K022095: Duraclean with Lycra Powder Free Polyurethane Medical Examination Glove (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K010297
Methodology: https://510kreport.com/methodology