# K140477: Biogel PS Surgical Glove Series, Biogel Skinsense Surgical Glove Series

- Pathway: 510(k) (Traditional)
- Applicant: Molnlycke Health Care Us, LLC
- Decided: Mar 23, 2015 after 390 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: 3 generations back to K011721 (2001). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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 7.
- K053102: Biogel Skinsense Powder-Free Non-Latex Surgeon's Glove, Regent Medical Americas, LLC (2006) Summary page 7.
- K110272: Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drug, Cardinal Health, Inc. (2011) Summary page 7.
- K013302: Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use with Chemotherapy Drugs Labeling Claim, Allegiance Healthcare Corp. (2001) Summary page 7.

## Most influential descendants
- K193573: Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro (2020), 0 descendants of its own

## Indications for use
Biogel® Skinsense® Surgical Gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infectious material, and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Biogel® PI UltraTouch™ G Surgical Gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infectious material, and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Source page: https://510kreport.com/device/K140477
Methodology: https://510kreport.com/methodology