The following data is part of a premarket notification filed by Rich Mountain Medical Products, Inc. with the FDA for Disposable Powder Free Vinyl Exam Glove, Blue Color.
Device ID | K120190 |
510k Number | K120190 |
Device Name: | DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR |
Classification | Vinyl Patient Examination Glove |
Applicant | RICH MOUNTAIN MEDICAL PRODUCTS, INC. 5748 EAGLEWOOD PLACE Rancho Cucamonga, CA 91739 |
Contact | Elizabeth Deng |
Correspondent | Elizabeth Deng RICH MOUNTAIN MEDICAL PRODUCTS, INC. 5748 EAGLEWOOD PLACE Rancho Cucamonga, CA 91739 |
Product Code | LYZ |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-01-23 |
Decision Date | 2012-04-02 |