| Primary Device ID | G53986702XL2 |
| NIH Device Record Key | 66282beb-3a4f-4834-9baf-0e73fbc978ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ambi-Gard |
| Version Model Number | 8670/2XL |
| Catalog Number | 8670/2XL |
| Company DUNS | 025199415 |
| Company Name | Saf-T-Gard International, 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 | false |
| Phone | 8472911600 |
| CustomerService@saftgard.com | |
| Phone | 8472911600 |
| CustomerService@saftgard.com | |
| Phone | 8472911600 |
| CustomerService@saftgard.com | |
| Phone | 8472911600 |
| CustomerService@saftgard.com | |
| Phone | 8472911600 |
| CustomerService@saftgard.com | |
| Phone | 8472911600 |
| CustomerService@saftgard.com | |
| Phone | 8472911600 |
| CustomerService@saftgard.com | |
| Phone | 8472911600 |
| CustomerService@saftgard.com | |
| Phone | 8472911600 |
| CustomerService@saftgard.com | |
| Phone | 8472911600 |
| CustomerService@saftgard.com | |
| Phone | 8472911600 |
| CustomerService@saftgard.com | |
| Phone | 8472911600 |
| CustomerService@saftgard.com | |
| Phone | 8472911600 |
| CustomerService@saftgard.com | |
| Phone | 8472911600 |
| CustomerService@saftgard.com | |
| Phone | 8472911600 |
| CustomerService@saftgard.com | |
| Phone | 8472911600 |
| CustomerService@saftgard.com | |
| Phone | 8472911600 |
| CustomerService@saftgard.com | |
| Phone | 8472911600 |
| CustomerService@saftgard.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G53986702XL0 [Unit of Use] |
| HIBCC | G53986702XL1 [Primary] |
| HIBCC | G53986702XL2 [Package] Contains: G53986702XL1 Package: Carton [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 | 2023-10-20 |
| Device Publish Date | 2023-10-12 |
| G5398670XS1 | Ambi-Gard Blue Nitrile Exam Gloves, Size XS |
| G5398670XL2 | Ambi-Gard Blue Nitrile Exam Gloves, Size XL |
| G5398670S2 | Ambi-Gard Blue Nitrile Exam Gloves, Size S |
| G5398670M2 | Ambi-Gard Blue Nitrile Exam Gloves, Size M |
| G5398670L2 | Ambi-Gard Blue Nitrile Exam Gloves, Size L |
| G53986702XL2 | Ambi-Gard Blue Nitrile Exam Gloves, Size 2XL |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AMBI-GARD 73602313 1438523 Live/Registered |
LATEX GLOVE CO., INC. 1986-06-04 |