# San-M Package Co., Ltd.

- Location (FDA's records): Shimada-City, JP
- FDA decisions: 3 (2016–2022): 3 510(k) clearances
- Product codes: FXX (2), MSH (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 40 (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 whose devices it cites most
- Kimberly-Clark Corp.: 2 (https://510kreport.com/company/kimberly-clark)
- Prestige Ameritech: 1 (https://510kreport.com/company/prestige-ameritech)

## Firms that cite its devices most
- Plastikon Industries: 1 (https://510kreport.com/company/plastikon-industries)
- United Sewing Automation, Inc.: 1 (https://510kreport.com/company/united-sewing-automation)
- Master & Frank Enterprise Co., Ltd.: 1 (https://510kreport.com/company/master-frank-enterprise)
- Knh Surgical Face Mask: 1 (https://510kreport.com/company/knh-surgical-face-mask)
- Guangdong Lide Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/guangdong-lide-medical-technology)
- Dukal Corp.: 1 (https://510kreport.com/company/dukal)
- Jiangsu Newvalue Medical Products Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-newvalue-medical-products)
- Jiangxi Hongda Medical Equipment Group, Ltd.: 1 (https://510kreport.com/company/jiangxi-hongda-medical-equipment-group)

## Its most-cited devices
- K160269: Surgical Face Masks (Ear loops and Tie-on) (2016), cited by 39
- K160271: N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 (2016), cited by 1

## Recent decisions
- K221534: Surgical Face Masks (Ear Loops And Tie-On) (Sep 16, 2022)
- K160269: Surgical Face Masks (Ear loops and Tie-on) (Sep 6, 2016)
- K160271: N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 (Jul 15, 2016)

Source page: https://510kreport.com/company/san-m-package