# K033905: Protegrity Steile Latex Surgical Gloves with Coating

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Apr 27, 2004 after 132 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.
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 its predicate without a number.
- (no number) Protegrity Sterile Latex Surgical Gloves: named in the summary without a submission number

## 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 latex gloves contain 50 micrograms or less of water extractable protein per gram.

Source page: https://510kreport.com/device/K033905
Methodology: https://510kreport.com/methodology