Specfit
GUDID 00196852445684
Powdered Free Disposable Examination Nitrile Glove,4Mil,Blue, S
Vallen Distribution, Inc.
Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove Utility glove| Primary Device ID | 00196852445684 |
| NIH Device Record Key | bdebbd59-b0c6-4547-9899-68a0931ceee0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Specfit |
| Version Model Number | DN4MBS |
| 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 | 00196852445684 [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 |
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