# K010862: Ultrafree Max Sterile Latex Poweder-Free Surgical Gloves with Protein Labeling Claim, 50 Per Gram or Less of Total Water

- Pathway: 510(k) (Traditional)
- Applicant: Allegiance Healthcare Corp.
- Decided: Jun 7, 2001 after 77 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K092304: Esteem Ortho Polyisoprene Powder-Free Surgical Gloves (2009), 1 descendant of its own
- K160875: Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K010862
Methodology: https://510kreport.com/methodology