| Primary Device ID | 01500199929605 |
| NIH Device Record Key | e929dbde-14ea-4fb9-8ed2-d3e23650c367 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NitriTech Ultra |
| Version Model Number | 61020PF-S |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | true |
| Phone | 13308680066 |
| tcalkins@summitglove.com | |
| Phone | 13308680066 |
| tcalkins@summitglove.com | |
| Phone | 13308680066 |
| tcalkins@summitglove.com | |
| Phone | 13308680066 |
| tcalkins@summitglove.com | |
| Phone | 13308680066 |
| tcalkins@summitglove.com | |
| Phone | 13308680066 |
| tcalkins@summitglove.com | |
| Phone | 13308680066 |
| tcalkins@summitglove.com | |
| Phone | 13308680066 |
| tcalkins@summitglove.com | |
| Phone | 13308680066 |
| tcalkins@summitglove.com | |
| Phone | 13308680066 |
| tcalkins@summitglove.com | |
| Phone | 13308680066 |
| tcalkins@summitglove.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850018374309 [Previous] |
| GS1 | 00850019992960 [Primary] |
| GS1 | 00850019992977 [Unit of Use] |
| GS1 | 01500199929605 [Package] Contains: 00850019992960 Package: BOX [1000 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 | 2022-11-28 |
| Device Publish Date | 2022-11-18 |
| 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 |