| Primary Device ID | 00852039000922 |
| NIH Device Record Key | ae01b060-09d8-420b-a1b6-cdade3631528 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TuffSkin XP |
| Version Model Number | MG1215M |
| Catalog Number | MG1215M |
| Company DUNS | 015809044 |
| Company Name | Medgluv Inc. |
| Device Count | 50 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com | |
| Phone | +1(866)633-4588 |
| sales@medgluv.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810145950166 [Unit of Use] |
| GS1 | 00852039000328 [Primary] |
| GS1 | 00852039000922 [Package] Contains: 00852039000328 Package: 50/bx, 10bx/cs [10 Units] In Commercial Distribution |
| LYY | Latex patient examination glove |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-08 |
| Device Publish Date | 2023-10-31 |
| 00852039000953 | TuffSkin XP Latex Exam Gloves, XC, Extra Extra Large |
| 00852039000946 | TuffSkin XP Latex Exam Gloves, XC, Extra Large |
| 00852039000939 | TuffSkin XP Latex Exam Gloves, XC, Large |
| 00852039000922 | TuffSkin XP Latex Exam Gloves, XC, Medium |
| 00852039000915 | TuffSkin XP Latex Exam Gloves, XC, Small |