The following data is part of a premarket notification filed by Dongguan Grinvald Technology Co., Ltd. with the FDA for Medcare Powder-free Blue Nitrile Patient Examination Gloves.
| Device ID | K211808 |
| 510k Number | K211808 |
| Device Name: | Medcare Powder-Free Blue Nitrile Patient Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Dongguan Grinvald Technology Co., Ltd. 401, Building #3 No 4 Of Guangming New Village 2 Road Dongcheng Dongguan, CN 52300 |
| Contact | Anna Roxana Grinvald |
| Correspondent | Aristotle Nafpliotis mdi Consultants, Inc. 55 Northern Blvd 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 | 2021-06-11 |
| Decision Date | 2022-03-04 |