| Primary Device ID | 10850018374801 |
| NIH Device Record Key | 83df981c-4086-433a-8128-1471c7596364 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | CRI-550-AG-XL |
| Company DUNS | 054386458 |
| Company Name | SUMMIT GLOVE INC. |
| Device Count | 135 |
| 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 | 00850018374804 [Primary] |
| GS1 | 00850018374811 [Unit of Use] |
| GS1 | 10850018374801 [Package] Contains: 00850018374804 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 |
| 00150062224200 - Get-A-Grip | 2024-05-07 Get-A-Grip Two-Toned Black/Green Powder Free, Exam Glove, Permeation Tested for Fentanyl, Heroin, and Gastric Acid Size S |
| 00150062224224 - Get-A-Grip | 2024-05-07 Get-A-Grip Two-Toned Black/Green Powder Free, Exam Glove, Permeation Tested for Fentanyl, Heroin, and Gastric Acid Size M |
| 00150062224248 - Get-A-Grip | 2024-05-07 Get-A-Grip Two-Toned Black/Green Powder Free, Exam Glove, Permeation Tested for Fentanyl, Heroin, and Gastric Acid Size L |
| 00150062224262 - Get-A-Grip | 2024-05-07 Get-A-Grip Two-Toned Black/Green Powder Free, Exam Glove, Permeation Tested for Fentanyl, Heroin, and Gastric Acid Size XL |
| 00150062224286 - Get-A-Grip | 2024-05-07 Get-A-Grip Two-Toned Black/Green Powder Free, Exam Glove, Permeation Tested for Fentanyl, Heroin, and Gastric Acid Size XXL |
| 00150062224309 - Get-A-Grip | 2024-05-07 Get-A-Grip Two-Toned Black/Green Powder Free, Exam Glove, Permeation Tested for Fentanyl, Heroin, and Gastric Acid Size XXXL |
| 00150062224323 - Get-A-Grip | 2024-05-07 Get-A-Grip Two-Toned Black/Green Powder Free, Exam Glove, Permeation Tested for Fentanyl, Heroin, and Gastric Acid Size S CTN |
| 00150062224347 - Get-A-Grip | 2024-05-07 Get-A-Grip Two-Toned Black/Green Powder Free, Exam Glove, Permeation Tested for Fentanyl, Heroin, and Gastric Acid Size M CTN |