The following data is part of a premarket notification filed by Alcatron Gloves Factory with the FDA for Alcatron And / Or Multiple Brand.
| Device ID | K112222 |
| 510k Number | K112222 |
| Device Name: | ALCATRON AND / OR MULTIPLE BRAND |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ALCATRON GLOVES FACTORY NO. 12-1, XING'AN RD EAST LINQU, WEIFANG Shandong, CN 262600 |
| Contact | Shuqin Gao |
| Correspondent | Shuqin Gao ALCATRON GLOVES FACTORY NO. 12-1, XING'AN RD EAST LINQU, WEIFANG Shandong, CN 262600 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-02 |
| Decision Date | 2011-10-27 |