The following data is part of a premarket notification filed by Eg Group Product And Services Co., Ltd with the FDA for Pp Care Nitrile Examination Gloves.
| Device ID | K212629 |
| 510k Number | K212629 |
| Device Name: | PP Care Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | EG Group Product And Services CO., Ltd 168/72 Nakniwat Road, Lat Phrao Bangkok, TH 10230 |
| Contact | Aristotle Nafpliotis |
| Correspondent | Tim Kania MDI Consultants Inc. 55 Northen Blvd, Suite 200 Great Neck, NY 11021 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-19 |
| Decision Date | 2022-05-26 |