# Louis M. Gerson Co., Inc.

- Location (FDA's records): Middleboro, MA
- FDA decisions: 8 (1980–2006): 8 510(k) clearances
- Product codes: FXX (4), MSH (3), LYU (1)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 10 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Aearo Company: 2 (https://510kreport.com/company/aearo)
- Makrite Industries, Inc.: 1 (https://510kreport.com/company/makrite-industries)
- Molnlycke Health Care, Inc.: 1 (https://510kreport.com/company/molnlycke-health-care)
- Inovel, LLC: 1 (https://510kreport.com/company/inovel)
- Racal Filter Technologies, Inc.: 1 (https://510kreport.com/company/racal-filter-technologies)
- Shanghai Dasheng Health Products: 1 (https://510kreport.com/company/shanghai-dasheng-health-products)
- Shanghai Gangkai Purifying Products Co., Ltd.: 1 (https://510kreport.com/company/shanghai-gangkai-purifying-products)
- Handan Hengyong Protective & Clean Products Co., L: 1 (https://510kreport.com/company/handan-hengyong-protective-clean-products-co-l)

## Its most-cited devices
- K960778: Isolair Apr Type N95 (1996), cited by 8
- K050193: Gerson 2130/31 Type N95 Niosh Certified Surgical Respirator (2005), cited by 1
- K922507: Gerson Isolair Apr Particulate Surgical Mask (1992), cited by 1

## Recent decisions
- K061375: Respirator N95 Particulate Respirator, Model 1730 (Nov 17, 2006)
- K050193: Gerson 2130/31 Type N95 Niosh Certified Surgical Respirator (Apr 11, 2005)
- K960778: Isolair Apr Type N95 (May 9, 1996)
- K925185: Isolair 2 Fluid Resist Surg/Proce/Cone/Earloop Mas (Feb 3, 1994)
- K931288: Isolair 2 Full Face Splash Guard (Jan 21, 1994)
- K922507: Gerson Isolair Apr Particulate Surgical Mask (Nov 16, 1992)
- K881910: Labeling Change to Surgical Face Mask (May 18, 1988)
- K802373: Surgical Face Mask (Nov 12, 1980)

Source page: https://510kreport.com/company/louis-m-gerson