Supmedic
GUDID 08500495926592
Supmedics Inc.
Nitrile examination/treatment glove, non-powdered, non-antimicrobial| Primary Device ID | 08500495926592 |
| NIH Device Record Key | a813928e-e6e8-443a-9a8c-1fbdfc3e53cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Supmedic |
| Version Model Number | SKF-M-9303 |
| Company DUNS | 107150886 |
| Company Name | Supmedics Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08500495926592 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212578
FDA Product Code
| LZA | Polymer Patient Examination Glove |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-02 |
| Device Publish Date | 2026-01-23 |
On-Brand Devices [Supmedic]
Trademark Results [Supmedic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUPMEDIC 97275035 not registered Live/Pending |
Supmedics Inc. 2022-02-18 |
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.