The following data is part of a premarket notification filed by Xuzhou Full Sun Medical Products Ltd. with the FDA for Disposable Powdered Vinyl Exam Glove, Yellow Color.
| Device ID | K071122 |
| 510k Number | K071122 |
| Device Name: | DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | XUZHOU FULL SUN MEDICAL PRODUCTS LTD. BIHE INDUSTRY AREA YITANG TOWN, PIZHOU COUNTY Jiangsu, CN |
| Contact | Hsun-hui Huang |
| Correspondent | Hsun-hui Huang XUZHOU FULL SUN MEDICAL PRODUCTS LTD. BIHE INDUSTRY AREA YITANG TOWN, PIZHOU COUNTY 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 | 2007-04-23 |
| Decision Date | 2007-12-12 |
| Summary: | summary |