The following data is part of a premarket notification filed by Sanrea Healthcare Products Pvt Ltd with the FDA for Sterile Nitrile Patient Examination Gloves, Powderfree.
| Device ID | K171093 |
| 510k Number | K171093 |
| Device Name: | STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE |
| Classification | Polymer Patient Examination Glove |
| Applicant | Sanrea Healthcare Products Pvt Ltd Plot #P-56, Pearl Road Kinfra IIT Park, Kanjikode Palakkad, IN 678 621 |
| Contact | Jose Paul M. |
| Correspondent | Jose Paul M. Sanrea Healthcare Products Pvt Ltd Plot #P-56, Pearl Road Kinfra IIT Park, Kanjikode Palakkad, IN 678 621 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-12 |
| Decision Date | 2017-07-19 |
| Summary: | summary |