# K112257: Biogel PI Orthopro Brown Surgical Glove

- Pathway: 510(k) (Special)
- Applicant: Molnlycke Health Care Us, LLC
- Decided: Sep 20, 2011 after 46 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 K050184 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050184: Biogel Skinsense Poly-Isoprene Powder-Free Non-Latex Glove, Regent Medical Americas, LLC (2005) Summary page 2.

## Indications for use
The Biogel® PI OrthoPro® Brown Surgical Glove is a disposable device made of non-latex (polyisoprene) colored brown, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

Source page: https://510kreport.com/device/K112257
Methodology: https://510kreport.com/methodology