# K051793: Encore Sterile Powder-Free Latex Surgical Glove with Proprietary Coating (Containing Glycerine)

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Healthcare Products, LLC
- Decided: Aug 17, 2005 after 47 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Jun 10, 2011 · Not classified · Z-2840-2011: Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
- Jun 10, 2011 · Not classified · Z-2846-2011: Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
- Jun 10, 2011 · Not classified · Z-2845-2011: Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
- Jun 10, 2011 · Not classified · Z-2844-2011: Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
- Jun 10, 2011 · Not classified · Z-2842-2011: Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
- Jun 10, 2011 · Not classified · Z-2843-2011: Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
- Jun 10, 2011 · Not classified · Z-2841-2011: Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.
- Jun 10, 2011 · Not classified · Z-2847-2011: Gloves do not meet the tensile requirements of ASTM D 3577 reducing the shelf life of the product from 5 years to 2 years.

## Indications for use
These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These latex gloves contain 50 micrograms or less of water extractable protein per gram.

Source page: https://510kreport.com/device/K051793
Methodology: https://510kreport.com/methodology