The following data is part of a premarket notification filed by Alcatron Gloves Factory with the FDA for Powder Free Nitrile Examination Gloves (white, Blue And Black).
| Device ID | K212998 |
| 510k Number | K212998 |
| Device Name: | Powder Free Nitrile Examination Gloves (White, Blue And Black) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Alcatron Gloves Factory NO. 12-1, Xing' An Road East, Linqu Weifang, CN 262600 |
| Contact | Hui Zhao |
| Correspondent | Hui Zhao Alcatron Gloves Factory NO. 12-1, Xing' An Road East, Linqu Weifang, CN 262600 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-20 |
| Decision Date | 2022-02-19 |