| Primary Device ID | 00810007662534 |
| NIH Device Record Key | caf49e7f-399b-489f-9255-204491522323 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HANDPRO |
| Version Model Number | 5500 |
| Company DUNS | 026777252 |
| Company Name | HOURGLASS INTERNATIONAL INC |
| Device Count | 2 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com | |
| Phone | 800-277-0994 |
| request@hourglass-intl.com |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify: Store under cool dry conditions. Avoid direct sunlight. Open box should be shielded from direct sunlight or fluorescent lighting. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810007662435 [Unit of Use] |
| GS1 | 00810007662480 [Primary] |
| GS1 | 00810007662534 [Package] Contains: 00810007662480 Package: Case [200 Units] In Commercial Distribution |
| LZC | Medical Glove, Specialty |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-23 |
| Device Publish Date | 2025-12-15 |
| 00810007662602 | 12" Sterile PF Nitrile Procedure Exam Gloves - XXL, 1 PR / 2 PCS |
| 00810007662572 | 12" Sterile PF Nitrile Procedure Exam Gloves - XL, 1 PR / 2 PCS |
| 00810007662565 | 12" Sterile PF Nitrile Procedure Exam Gloves - L, 1 PR / 2 PCS |
| 00810007662558 | 12" Sterile PF Nitrile Procedure Exam Gloves - M, 1 PR / 2 PCS |
| 00810007662541 | 12" Sterile PF Nitrile Procedure Exam Gloves - S, 1 PR / 2 PCS |
| 00810007662534 | 12" Sterile PF Nitrile Procedure Exam Gloves - XS, 1 PR / 2 PCS |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HANDPRO 85924272 4461701 Live/Registered |
Hourglass International, Inc. 2013-05-06 |
![]() HANDPRO 78749825 not registered Dead/Abandoned |
HourGlass Industries, Inc. 2005-11-08 |