Data / Medical devices / United States / Polyconversions, Inc.
Polyconversions, Inc.: FDA-registered device maker in Champaign, IL, United States, 3 510(k) clearances
Polyconversions, Inc. is registered with the FDA (registration 1423205) in Champaign, IL, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 16, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1423205
- FEI number
- 3001239227
- Address
- 3202 Apollo Drive, Champaign, IL, United States, 61822
- Owner or operator
- PolyConversions, Inc. (9047406)
- Roles
- Manufacturer
- First device listed
- June 4, 2002
- Registered through
- 2026
- Brand names listed
- PolyWear, PolyWear Gowns, PolyWear Personal Protective Level 3 Gown, VR Personal Protective Level 3 Gown, VR Shoe Covers, VR Sleeve Gloves
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Finger Cot | LZB | 1 | Manufacturer | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Manufacturer | accessdata.fda.gov |
| Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | QPC | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | 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 |
|---|---|---|---|---|---|---|
| December 16, 2025 | K252940 | VR® Personal Protective Level 3 Gown (VR Gowns) | QPC | Substantially Equivalent | PolyConversions, Inc. | accessdata.fda.gov |
| August 11, 2023 | K230384 | PolyWear® Personal Protective Level 3 Gown | QPC | Substantially Equivalent | PolyConversions, Inc. | accessdata.fda.gov |
| August 16, 1993 | K925077 | POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS | FYC | Substantially Equivalent | Medtek Development Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Gown, Isolation, Surgical
- All makers of Non-Surgical Gown
- All makers of Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
- All makers of Accessory, Surgical Apparel
- All makers of Finger Cot
Updated December 16, 2025. 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.