The following data is part of a premarket notification filed by Shanghai Pm Plastics Enterise Co., Ltd. with the FDA for Disposable Powder Free Vinyl Synthetic Exam Gloves With Aloe Vera, Green Color.
| Device ID | K024026 |
| 510k Number | K024026 |
| Device Name: | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANGHAI PM PLASTICS ENTERISE CO., LTD. 258 YUSHU RD. CANGQIAO TOWNSHIP Shongjiang County, Shanghai, CN 201600 |
| Contact | Chang Te Sun |
| Correspondent | Chang Te Sun SHANGHAI PM PLASTICS ENTERISE CO., LTD. 258 YUSHU RD. CANGQIAO TOWNSHIP Shongjiang County, Shanghai, CN 201600 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-06 |
| Decision Date | 2002-12-18 |