Data / Medical devices / Canada / Polymed Chirurgical Inc.
Polymed Chirurgical Inc.: FDA-registered device maker in Saint-Laurent Quebec, Canada, 2 510(k) clearances
Polymed Chirurgical Inc. is registered with the FDA (registration 3004995451) in Saint-Laurent Quebec, Canada. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 25, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004995451
- Address
- 387 Avenue Sainte-Croix, Saint-Laurent Quebec, Canada, H4N2L3
- Owner or operator
- Polymed Chirurgical Inc. (10080716)
- Roles
- Exporter to the US
- First device listed
- February 22, 2021
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mask, Surgical | FXX | 2 | Exporter to the US | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| August 25, 2017 | K170136 | Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Shandong Feiyang Professional Gloves Co., Ltd. | accessdata.fda.gov |
| June 10, 2003 | K023755 | WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD | FXX | Substantially Equivalent | Winner Industries (Shenzhen) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Surgical
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
Updated August 25, 2017. 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.