The following data is part of a premarket notification filed by Full Synergy Medical Products Inc with the FDA for Disposable Vinyl Exam Glove, Powder Free.
| Device ID | K113797 |
| 510k Number | K113797 |
| Device Name: | DISPOSABLE VINYL EXAM GLOVE, POWDER FREE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | FULL SYNERGY MEDICAL PRODUCTS INC 5748 EAGLEWOOD PLACE Rancho Cucamonga, CA 91739 |
| Contact | Elizabeth Deng |
| Correspondent | Elizabeth Deng FULL SYNERGY 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 | 2011-12-23 |
| Decision Date | 2012-03-02 |