| Primary Device ID | 40727351800957 |
| NIH Device Record Key | 368b051b-7ab0-4b02-8dd7-171ba28528dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SAFEHAND |
| Version Model Number | M2650031 |
| Catalog Number | M2650031 |
| Company DUNS | 799540588 |
| Company Name | Bunzl USA Holdings LLC |
| 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 | 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 | true |
| Length | 240 Millimeter |
| Width | 105 Millimeter |
| Length | 240 Millimeter |
| Width | 105 Millimeter |
| Length | 240 Millimeter |
| Width | 105 Millimeter |
| Length | 240 Millimeter |
| Width | 105 Millimeter |
| Length | 240 Millimeter |
| Width | 105 Millimeter |
| Length | 240 Millimeter |
| Width | 105 Millimeter |
| Length | 240 Millimeter |
| Width | 105 Millimeter |
| Length | 240 Millimeter |
| Width | 105 Millimeter |
| Length | 240 Millimeter |
| Width | 105 Millimeter |
| Length | 240 Millimeter |
| Width | 105 Millimeter |
| Length | 240 Millimeter |
| Width | 105 Millimeter |
| Length | 240 Millimeter |
| Width | 105 Millimeter |
| Length | 240 Millimeter |
| Width | 105 Millimeter |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Direct Sunlight, Keep Dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Direct Sunlight, Keep Dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Direct Sunlight, Keep Dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Direct Sunlight, Keep Dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Direct Sunlight, Keep Dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Direct Sunlight, Keep Dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Direct Sunlight, Keep Dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Direct Sunlight, Keep Dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Direct Sunlight, Keep Dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Direct Sunlight, Keep Dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Direct Sunlight, Keep Dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Direct Sunlight, Keep Dry |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid Direct Sunlight, Keep Dry |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00727351800959 [Unit of Use] |
| GS1 | 20727351800953 [Primary] |
| GS1 | 40727351800957 [Package] Contains: 20727351800953 Package: CASE [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 | 2024-05-06 |
| Device Publish Date | 2024-04-26 |
| 40727351800896 | SH GLOVE POWDER FREE EXAM NITRILE SMALL BLACK |
| 40727351800926 | SH GLOVE POWDER FREE EXAM NITRILE X-LARGE BLACK |
| 40727351800919 | SH GLOVE POWDER FREE EXAM NITRILE LARGE BLACK |
| 40727351800902 | SH GLOVE POWDER FREE EXAM NITRILE MEDIUM BLACK |
| 40727351800964 | SH GLOVE POWDER FREE EXAM NITRILE X-LARGE BLUE |
| 40727351800957 | SH GLOVE POWDER FREE EXAM NITRILE LARGE BLUE |
| 00727351800942 | SH GLOVE POWDER FREE EXAM NITRILE MEDIUM BLUE |
| 40727351800933 | SH GLOVE POWDER FREE EXAM NITRILE SMALL BLUE |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SAFEHAND 90245304 not registered Live/Pending |
Iowa Medical PPE Supplies LLC 2020-10-09 |
![]() SAFEHAND 86263073 4652385 Live/Registered |
Boveja, Dean, D 2014-04-25 |