# Molnlycke Health Care Us, LLC

- Location (FDA's records): Norcross, GA
- FDA decisions: 27 (2006–2023): 27 510(k) clearances
- Product codes: KGO (16), OMP (7), DWJ (2), FRO (1), OXJ (1)
- 510(k) review time since 2016: median 117 days, against 146 for FDA's reviews in the same codes and years (9 of 11 faster)
- Predicates its devices cite: 38 (14 its own); citations of its devices by later devices: 20 (14 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Regent Medical Americas, LLC: 7 (https://510kreport.com/company/regent-medical-americas)
- Molnlycke Health Care, Inc.: 3 (https://510kreport.com/company/molnlycke-health-care)
- London International Group, Inc.: 3 (https://510kreport.com/company/london-international-group)
- Biobarrier, Inc.: 2 (https://510kreport.com/company/biobarrier)
- Talley Medical: 1 (https://510kreport.com/company/talley-medical)
- Convatec Limited: 1 (https://510kreport.com/company/convatec)
- Augustine Biomedical & Design, LLC: 1 (https://510kreport.com/company/augustine-biomedical-design)
- Cardinal Health, Inc.: 1 (https://510kreport.com/company/cardinal-health)

## Firms that cite its devices most
- Molnlycke Health Care USA: 2 (https://510kreport.com/company/molnlycke-health-care-usa)
- Smith & Nephew Medical Limited: 1 (https://510kreport.com/company/smith-nephew-medical)
- Ansell Healthcare Products, LLC: 1 (https://510kreport.com/company/ansell-healthcare-products)
- Genadyne Biotechnologies, Inc.: 1 (https://510kreport.com/company/genadyne-biotechnologies)
- Medela AG: 1 (https://510kreport.com/company/medela)

## Its most-cited devices
- K141847: Avance Foam Dressing Kits (2015), cited by 5
- K071465: Biogel Orthopaedic Surgical Glove with Non-Pryogenic Statement (2007), cited by 2
- K151872: Avance Y-Connector S (2015), cited by 2
- K111413: Biogel (R) Indicator (R) Underglove (2012), cited by 2
- K190077: Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove (2019), cited by 2
- K062847: Biogel Eclipse Indicator Underglove (2006), cited by 1

## Recent decisions
- K232508: Barrier EasyWarm Active Self-Warming Blanket (Sep 15, 2023)
- K203369: Avance Solo Negative Pressure Wound Therapy (NPWT) System (Jul 1, 2021)
- K202090: Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim (Nov 22, 2020)
- K193573: Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro (Apr 10, 2020)
- K191869: Biogel (R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel (R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim (Mar 13, 2020)
- K190077: Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove (May 24, 2019)
- K161939: Avance Abdominal Dressing Kit (Nov 17, 2016)
- K161935: Avance Foam Dressing Kit - XL (Nov 4, 2016)

Source page: https://510kreport.com/company/molnlycke-health-care-us