The following data is part of a premarket notification filed by Shanghai Pt Plastics Enterprise Company, Ltd. with the FDA for Disposable Pvc Powdered Synthetic Exam Gloves.
| Device ID | K001601 |
| 510k Number | K001601 |
| Device Name: | DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD. NO. 268, YUSHU ROAD CANGQIAO TOWNSHIP Songjiang County Shanghai, CN |
| Contact | Peter Wang |
| Correspondent | Peter Wang SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD. NO. 268, YUSHU ROAD CANGQIAO TOWNSHIP Songjiang 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 | 2000-05-24 |
| Decision Date | 2000-06-23 |