| Primary Device ID | 10860010400910 |
| NIH Device Record Key | a9d0adaa-1993-492c-a1bc-c35368e9cbbd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Luvatek |
| Version Model Number | GL-LTE-PF-M |
| Company DUNS | 117081780 |
| Company Name | R&C Imports LLC |
| Device Count | 100 |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860010400913 [Primary] |
| GS1 | 10860010400910 [Package] Contains: 00860010400913 Package: Case [10 Units] In Commercial Distribution |
| GS1 | 20860010400917 [Unit of Use] |
| LZA | Polymer 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 | 2025-01-29 |
| Device Publish Date | 2025-01-21 |
| 10860010400910 - Luvatek | 2025-01-29Blue Nitrile Examination Glove, Powder Free, Finger Textured, Tested for use with Chemotherapy Drugs - Medium, Inner pack |
| 10860010400910 - Luvatek | 2025-01-29 Blue Nitrile Examination Glove, Powder Free, Finger Textured, Tested for use with Chemotherapy Drugs - Medium, Inner pack |
| 10860010400965 - Axis | 2024-08-13 Blue Nitrile Examination Glove, Powder Free, Finger Textured, Tested for us with Chemotherapy Drugs, Medium, Inner Pack |
| 10860010400972 - Axis | 2024-08-13 Blue Nitrile Examination Glove, Powder Free, Finger Textured, Tested for use with Chemotherapy Drugs, Small, Inner Pack |
| 10860010400989 - Axis | 2024-08-13 Blue Nitrile Examination glove, Powder Free, Finger Textured, Tested for use with Chemotherapy Drugs, Large, Inner Pack |
| 10860010400996 - Axis | 2024-08-13 Blue Nitrile Examination glove, Powder Free, Finger Textured, Tested for use with Chemotherapy Drugs, X-Large, Inner Pack |