The following data is part of a premarket notification filed by Xuzhou Full Sun Medical Products Ltd. with the FDA for Disposable Powder Free Vinyl Synthetic Examination Glove, Blue Color.
| Device ID | K111240 |
| 510k Number | K111240 |
| Device Name: | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, BLUE COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | XUZHOU FULL SUN MEDICAL PRODUCTS LTD. 5748 EAGLEWOOD PLACE Rancho Cucamonga, CA 91739 |
| Contact | Elizabeth Deng |
| Correspondent | Elizabeth Deng XUZHOU FULL SUN MEDICAL PRODUCTS LTD. 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 | 2011-05-03 |
| Decision Date | 2011-07-14 |
| Summary: | summary |