# K053272: Cardinal Health Protegrity Blue with Neu-Thera Surgical Gloves

- Pathway: 510(k) (Special)
- Applicant: Cardinalhealth
- Decided: Jan 5, 2006 after 43 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 K001924 (2000). 1 ancestor in all.
1 later device descends 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)
- K001924: Coated Sterile Latex Powdeer-Free Surgical Gloves with Protein Content Labeling Claim (50 Microgram or LESS0, Allegiance Healthcare Corp. (2000) Summary page 1.

## Most influential descendants
- K111878: Protexis Latex Blue with Neu-Thera Powder-Free Surgical Gloves (2011), 0 descendants of its own

## Indications for use
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility. These gloves contain 50 micrograms or less of water extractable protein per gram.

Source page: https://510kreport.com/device/K053272
Methodology: https://510kreport.com/methodology