Data / Medical devices / Japan / San-M Package Co., Ltd.
San-M Package Co., Ltd.: FDA-registered device maker in Shimada-city Shizuoka, Japan, 3 510(k) clearances
San-M Package Co., Ltd. is registered with the FDA (registration 9612018) in Shimada-city Shizuoka, Japan. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 16, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9612018
- FEI number
- 3002809487
- Address
- 1086-1 Ojiro, Shimada-city Shizuoka, Japan, 428-0009
- Owner or operator
- SAN-M PACKAGE CO., LTD. (8031533)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 26, 2008
- Registered through
- 2026
- Brand names listed
- BARRIER Extra Protection Face Mask, BARRIER Extra Protection Plus Face, BARRIER Laser Plume Face Mask, MR Safe Surgical Face Mask, Medical Face Mask, N95 Particulate Respirator, SOFLOOP Extra Protection Face Mask, SOFLOOP Extra Protection Plus Face and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mask, Surgical | FXX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 16, 2022 | K221534 | Surgical Face Masks (Ear Loops And Tie-On) | FXX | Substantially Equivalent | San-M Package Co., Ltd. | accessdata.fda.gov |
| September 6, 2016 | K160269 | Surgical Face Masks (Ear loops and Tie-on) | FXX | Substantially Equivalent | San-M Package Co., Ltd. | accessdata.fda.gov |
| July 15, 2016 | K160271 | N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 | MSH | Substantially Equivalent | San-M Package Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 16, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.