AmbiNitrile
GUDID 10850018374160
11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Pattern, Beaded Cuff, Blue, Size X-Large
SUMMIT GLOVE INC.
Nitrile examination/treatment glove, non-powdered, non-antimicrobial| Primary Device ID | 10850018374160 |
| NIH Device Record Key | eae849e4-a7e3-4941-8a4b-71ac9af9dcf9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AmbiNitrile |
| Version Model Number | 570-BL-10 |
| Company DUNS | 054386458 |
| Company Name | SUMMIT GLOVE INC. |
| Device Count | 24 |
| 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 |
Customer Support Contacts
| 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 | |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850018374163 [Primary] |
| GS1 | 00850018374170 [Unit of Use] |
| GS1 | 10850018374160 [Package] Contains: 00850018374163 Package: Box [24 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K990878
FDA Product Code
| LZA | Polymer patient examination glove |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-10 |
| Device Publish Date | 2020-08-01 |
On-Brand Devices [AmbiNitrile]
| 10850019992882 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850019992868 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850019992844 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850019992820 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850019992806 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850019992783 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850019992769 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850019992745 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850019992721 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850019992707 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850018374283 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850018374269 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850018374245 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850018374221 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850018374207 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850018374184 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850018374160 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850018374146 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850018374122 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
| 10850018374108 | 11.5mil, 13" in Length, Nitrile, Examination Grade, Ambidextrous, Unlined, Raised Diamond Patter |
Trademark Results [AmbiNitrile]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMBINITRILE 85369326 4184279 Live/Registered |
Summit Glove Inc. 2011-07-12 |
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