The following data is part of a premarket notification filed by Shanghai Pm Plastics Enterise Co., Ltd. with the FDA for Disposbable Powdered Vinyl Synthetic Exam Gloves, White Color.
| Device ID | K002814 |
| 510k Number | K002814 |
| Device Name: | DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANGHAI PM PLASTICS ENTERISE CO., LTD. 258 YUSHU RD. CANGQIAO TOWNSHIP Shongjiang County, Shanghai, CN |
| Contact | Chang T Sun |
| Correspondent | Chang T Sun SHANGHAI PM PLASTICS ENTERISE CO., LTD. 258 YUSHU RD. CANGQIAO TOWNSHIP Shongjiang County, Shanghai, CN |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-11 |
| Decision Date | 2000-10-20 |