SUPMEDIC
GUDID 00810160180104
Supmedics Inc.
Nitrile examination/treatment glove, non-powdered, non-antimicrobial| Primary Device ID | 00810160180104 |
| NIH Device Record Key | c768e7ca-ff94-440f-8014-536881d0f36b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SUPMEDIC |
| Version Model Number | BTN3444 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810160180104 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221887
FDA Product Code
| LZA | Polymer Patient Examination Glove |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2025-02-06 |
| Device Publish Date | 2024-11-04 |
On-Brand Devices [SUPMEDIC]
| 00810160180395 | SKF03301 |
| 00810160180388 | SKF03304 |
| 00810160180371 | SKF03303 |
| 00810160180364 | SKF03302 |
| 00810160180357 | SKF3301 |
| 00810160180340 | SKF3304 |
| 00810160180333 | SKF3303 |
| 00810160180326 | SKF3302 |
| 00810160180319 | SKF02305 |
| 00810160180302 | SKF02304 |
| 00810160180296 | SKF02303 |
| 00810160180289 | SKF02302 |
| 00810160180272 | SKF2305 |
| 00810160180265 | SKF2304 |
| 00810160180258 | SKF2303 |
| 00810160180241 | SKF2302 |
| 00810160180111 | BTN3441 |
| 00810160180104 | BTN3444 |
| 00810160180463 | Powder Free Nitrile Examination Gloves (L size) |
| 00810160180456 | Powder Free Nitrile Examination Gloves (M size) |
| 00810160181996 | Powder Free Nitrile Examination Gloves (S size) |
Trademark Results [SUPMEDIC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUPMEDIC 97275035 not registered Live/Pending |
Supmedics Inc. 2022-02-18 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.