The following data is part of a premarket notification filed by Hong Di Plastic Products Co, Ltd. with the FDA for Powder Free Vinyl Patient Examination Glove.
Device ID | K070187 |
510k Number | K070187 |
Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVE |
Classification | Vinyl Patient Examination Glove |
Applicant | HONG DI PLASTIC PRODUCTS CO, LTD. 3973 SCHAEFER AVE. Chino, CA 91710 |
Contact | Kathy Liu |
Correspondent | Kathy Liu HONG DI PLASTIC PRODUCTS CO, LTD. 3973 SCHAEFER 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 | 2007-01-22 |
Decision Date | 2007-02-13 |
Summary: | summary |