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 |