The following data is part of a premarket notification filed by Rich Mountain Medical Products, Inc. with the FDA for Disposable Powder Free Vinyl Synthetic Exam Gloves, White Color.
| Device ID | K081535 |
| 510k Number | K081535 |
| Device Name: | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | RICH MOUNTAIN MEDICAL PRODUCTS, INC. NO. 8, JIANG YIN ROAD YI TANG TOWNSHIP Pizhou, Jiangsu, CN |
| Contact | Michelle Shih |
| Correspondent | Michelle Shih RICH MOUNTAIN MEDICAL PRODUCTS, INC. NO. 8, JIANG YIN ROAD YI TANG TOWNSHIP Pizhou, Jiangsu, CN |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-02 |
| Decision Date | 2008-08-14 |
| Summary: | summary |