ASSURE PLUS
GUDID 00850053354489
ASSURE PLUS Exam Nitrile Glove, 5.0mil, Size X-Large, Blue, Chemo-Tested, Single Use, Box of 100
Poss, LLC
Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial| Primary Device ID | 00850053354489 |
| NIH Device Record Key | 9733b7f6-e819-4a4b-8df3-719b65ffbe7d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASSURE PLUS |
| Version Model Number | ASRP350 |
| Company DUNS | 066882769 |
| Company Name | Poss, 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 | 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 | 00850053354465 [Unit of Use] |
| GS1 | 00850053354472 [Primary] |
| GS1 | 00850053354489 [Package] Contains: 00850053354472 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 PLUS]
| 00850053354489 | ASSURE PLUS Exam Nitrile Glove, 5.0mil, Size X-Large, Blue, Chemo-Tested, Single Use, Box of 100 |
| 00850053354458 | ASSURE PLUS Exam Nitrile Glove, 5.0mil, Size Large, Blue, Chemo-Tested, Single Use, Box of 100 |
| 00850053354427 | ASSURE PLUS Exam Nitrile Glove, 5.0mil, Size Medium, Blue, Chemo-Tested, Single Use, Box of 100 |
| 00850053354397 | ASSURE PLUS Exam Nitrile Glove, 5.0mil, Size Small, Blue, Chemo-Tested, Single Use, Box of 100 |
Trademark Results [ASSURE PLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ASSURE PLUS 97065581 not registered Live/Pending |
Reliance Orthodontic Products, Inc. 2021-10-08 |
 ASSURE PLUS 78881821 3302175 Dead/Cancelled |
ALTERA INTERNATIONAL, LTD 2006-05-11 |
 ASSURE PLUS 78364625 2923385 Live/Registered |
DENTSPLY SIRONA INC. 2004-02-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.