The following data is part of a premarket notification filed by Dainam Glove Joint Stock Company with the FDA for Powder Free Nitrile Examination Glove.
| Device ID | K212751 |
| 510k Number | K212751 |
| Device Name: | Powder Free Nitrile Examination Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Dainam Glove Joint Stock Company 1765A Binh Duono Avenue, Hiep An Ward Thu DAu Mot, VN |
| Contact | Damon Nguyen |
| Correspondent | Jenny Nguyen Bayneto LLC 13480 Veterans Memorial Drive, Suite F Houston, TX 77014 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-30 |
| Decision Date | 2022-09-24 |