The following data is part of a premarket notification filed by Inmed Gloves Factory with the FDA for Synthetic Vinyl Examination Glove Powder Free.
Device ID | K111857 |
510k Number | K111857 |
Device Name: | SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE |
Classification | Vinyl Patient Examination Glove |
Applicant | INMED GLOVES FACTORY 10-2 XING'AN RD. EAST, LINQU, Weifang, Shandong, CN 262600 |
Contact | Xiaobing Li |
Correspondent | Xiaobing Li INMED GLOVES FACTORY 10-2 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 | 2011-06-30 |
Decision Date | 2011-09-21 |