Specfit
GUDID 00196852902323
Powdered Free Disposable Examination Nitrile Glove,4Mil,Blue, L
Vallen Distribution, Inc.
Utility glove| Primary Device ID | 00196852902323 |
| NIH Device Record Key | a7713dea-9ec0-4e05-839c-71a163145d31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Specfit |
| Version Model Number | DN4MBL |
| Company DUNS | 782807804 |
| Company Name | Vallen Distribution, Inc. |
| Device Count | 1 |
| 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 | false |
| 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 |
Device Dimensions
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
| Length | 8 Millimeter |
| Length | 2.25 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00196852902323 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121526
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 | 2023-10-09 |
| Device Publish Date | 2023-09-29 |
On-Brand Devices [Specfit]
| 00196852952410 | Powdered Free Disposable Examination Nitrile Glove,4Mil,Blue, M |
| 00196852902323 | Powdered Free Disposable Examination Nitrile Glove,4Mil,Blue, L |
| 00196852445684 | Powdered Free Disposable Examination Nitrile Glove,4Mil,Blue, S |
| 00196852240364 | Powdered Free Disposable Examination Nitrile Glove,4Mil,Blue, XL |
Trademark Results [Specfit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPECFIT 97752035 not registered Live/Pending |
Wheel Pros, LLC 2023-01-12 |
 SPECFIT 88618202 not registered Live/Pending |
Sonepar Management US, Inc. 2019-09-16 |
 SPECFIT 78721956 3287874 Dead/Cancelled |
Risso, Mark S. 2005-09-28 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.