| Primary Device ID | 10850018374368 |
| NIH Device Record Key | 0588bb7a-5c3d-4a0b-be3a-983bb99b4c35 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NitriTech Ultra |
| Version Model Number | 61050PF-XL |
| Company DUNS | 054386458 |
| Company Name | SUMMIT GLOVE INC. |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(330)868-0066 |
| klynn@summitglove.com | |
| Phone | +1(330)868-0066 |
| klynn@summitglove.com | |
| Phone | +1(330)868-0066 |
| klynn@summitglove.com | |
| Phone | +1(330)868-0066 |
| klynn@summitglove.com | |
| Phone | +1(330)868-0066 |
| klynn@summitglove.com | |
| Phone | +1(330)868-0066 |
| klynn@summitglove.com | |
| Phone | +1(330)868-0066 |
| klynn@summitglove.com | |
| Phone | +1(330)868-0066 |
| klynn@summitglove.com | |
| Phone | +1(330)868-0066 |
| klynn@summitglove.com | |
| Phone | +1(330)868-0066 |
| klynn@summitglove.com | |
| Phone | +1(330)868-0066 |
| klynn@summitglove.com | |
| Phone | +1(330)868-0066 |
| klynn@summitglove.com | |
| Phone | +1(330)868-0066 |
| klynn@summitglove.com | |
| Phone | +1(330)868-0066 |
| klynn@summitglove.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850018374361 [Primary] |
| GS1 | 00850018374378 [Unit of Use] |
| GS1 | 10850018374368 [Package] Contains: 00850018374361 Package: Box [10 Units] In Commercial Distribution |
| 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 | 2020-08-10 |
| Device Publish Date | 2020-08-01 |
| 10850020255044 | 6mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish |
| 10850020255020 | 6mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish |
| 10850020255006 | 6mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish |
| 10850019992981 | 6mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish |
| 10850019992943 | 6mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish |
| 10850019992929 | 6mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish |
| 10850019992905 | 6mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish |
| 10850018374429 | 6mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish |
| 10850018374405 | 6mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish |
| 10850018374382 | 6mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish |
| 10850018374368 | 6mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish |
| 10850018374344 | 6mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish |
| 10850018374320 | 6mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish |
| 10850018374306 | 6mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish |
| 01500199929605 | 6mil, 12" in Length, Nitrile, Examination Grade, Ambidextrous, Powder Free, Microtextured Finish |