The following data is part of a premarket notification filed by Zibo Intco Medical Products Co., Ltd. with the FDA for Powder-free Vinyl Patient Examination Gloves, Yellow Color.
Device ID | K132637 |
510k Number | K132637 |
Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR |
Classification | Vinyl Patient Examination Glove |
Applicant | ZIBO INTCO MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE. Chino, CA 91710 |
Contact | Frank Liu |
Correspondent | Frank Liu ZIBO INTCO MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE. Chino, CA 91710 |
Product Code | LYZ |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-23 |
Decision Date | 2014-05-01 |
Summary: | summary |