ASSURE
GUDID 00850053354366
ASSURE Nitrile Exam Glove, 3.5mil, Size X-Large, Blue, Chemo-Tested, Non-Sterile, Single Use, Box of 200
Poss, LLC
Nitrile examination/treatment glove, non-powdered, non-antimicrobial| Primary Device ID | 00850053354366 |
| NIH Device Record Key | e335e314-e49a-4268-b50f-767918b33eaf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASSURE |
| Version Model Number | ASR350 |
| Company DUNS | 066882769 |
| Company Name | Poss, LLC |
| Device Count | 200 |
| 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 | true |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850053354342 [Unit of Use] |
| GS1 | 00850053354359 [Primary] |
| GS1 | 00850053354366 [Package] Contains: 00850053354359 Package: [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170136
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 | 2023-10-01 |
On-Brand Devices [ASSURE]
| 00850053354366 | ASSURE Nitrile Exam Glove, 3.5mil, Size X-Large, Blue, Chemo-Tested, Non-Sterile, Single Use, Bo |
| 00850053354335 | ASSURE Nitrile Exam Glove, 3.5mil, Size Large, Blue, Chemo-Tested, Non-Sterile, Single Use, Box |
| 00850053354304 | ASSURE Nitrile Exam Glove, 3.5mil, Size Medium, Blue, Chemo-Tested, Non-Sterile, Single Use, Box |
| 00850053354274 | ASSURE Nitrile Exam Glove, 3.5mil, Size Small, Blue, Chemo-Tested, Non-Sterile, Single Use, Box |
Trademark Results [ASSURE]
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