The following data is part of a premarket notification filed by Koove Iot Pvt. Ltd. with the FDA for 1st Glove Blue Nitrile Examination Gloves Powder Free.
| Device ID | K221226 |
| 510k Number | K221226 |
| Device Name: | 1st Glove Blue Nitrile Examination Gloves Powder Free |
| Classification | Polymer Patient Examination Glove |
| Applicant | Koove Iot Pvt. Ltd. Gokulpur, PO:Shyamraipur Paschim Midnapur, IN 721305 |
| Contact | Sudarsan Mohapatra |
| Correspondent | Manoj Zacharias Liberty Management Group Ltd. 75 Executive Dr. STE114 Aurora, IL 60504 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-28 |
| Decision Date | 2022-06-16 |