The following data is part of a premarket notification filed by Amazing Rubber Products Pvt Ltd with the FDA for Blue Nitrile Examination Gloves Powder Free.
| Device ID | K212584 |
| 510k Number | K212584 |
| Device Name: | Blue Nitrile Examination Gloves Powder Free |
| Classification | Polymer Patient Examination Glove |
| Applicant | Amazing Rubber Products Pvt Ltd Plot No 14c, Cochin Special Economic Zone Cochin, IN 682037 |
| Contact | Jayasankar S |
| 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 | 2021-08-16 |
| Decision Date | 2022-05-28 |