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.
Device ID | K091942 |
510k Number | K091942 |
Device Name: | POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES |
Classification | Vinyl Patient Examination Glove |
Applicant | ZIBO INTCO MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE. Chino, CA 91710 |
Contact | John Zhao |
Correspondent | John Zhao 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 | 2009-06-30 |
Decision Date | 2009-09-21 |