# K001924: Coated Sterile Latex Powdeer-Free Surgical Gloves with Protein Content Labeling Claim (50 Microgram or LESS0

- Pathway: 510(k) (Special)
- Applicant: Allegiance Healthcare Corp.
- Decided: Jul 14, 2000 after 21 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: 8 (0 Class I)
- 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
- K053272: Cardinal Health Protegrity Blue with Neu-Thera Surgical Gloves (2006), 1 descendant of its own
- K111878: Protexis Latex Blue with Neu-Thera Powder-Free Surgical Gloves (2011), 0 descendants of its own

## Recalls of this device
- Jul 29, 2020 · Class II · Z-2916-2020: A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
- Jul 29, 2020 · Class II · Z-2913-2020: A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
- Jul 29, 2020 · Class II · Z-2919-2020: A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
- Jul 29, 2020 · Class II · Z-2917-2020: A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
- Jul 29, 2020 · Class II · Z-2918-2020: A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
- Jul 29, 2020 · Class II · Z-2914-2020: A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
- Jul 29, 2020 · Class II · Z-2915-2020: A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
- Jul 29, 2020 · Class II · Z-2912-2020: A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Source page: https://510kreport.com/device/K001924
Methodology: https://510kreport.com/methodology