# K101811: Protegrity SMT Latex Surgicalgloves

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Inc.
- Decided: Oct 15, 2010 after 108 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
Longest line of descent: 1 generation back to K992171 (1999). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K992171: Coated Sterile Latex Powder-Free Surgical Gloves with Protein Content Labeling Claim (50 Micrograms or Less), Allegiance Healthcare Corp. (1999) Summary page 2.

## Most influential descendants
- K111015: Sterile Latex Powder Free Surgical Gloves with Hydrogel Coating (2011), 2 descendants of its own
- K151778: Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating (2016), 1 descendant of its own
- K160875: Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating (2016), 0 descendants of its own

## Indications for use
These powder-free sterile brown color surgeon's gloves with Nitrile coating are a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.

Source page: https://510kreport.com/device/K101811
Methodology: https://510kreport.com/methodology