The following data is part of a premarket notification filed by Shanghai Pm Plastics Enterise Co., Ltd. with the FDA for Pm Synthetic Medical Gloves, Powder Free.
| Device ID | K963797 |
| 510k Number | K963797 |
| Device Name: | PM SYNTHETIC MEDICAL GLOVES, POWDER FREE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANGHAI PM PLASTICS ENTERISE CO., LTD. NO. 258, YUSHU ROAD CANGQIAO TOWNSHIP Songjiang County, Shanghai, CN |
| Contact | Chang Te Sun |
| Correspondent | Chang Te Sun SHANGHAI PM PLASTICS ENTERISE CO., LTD. NO. 258, 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 | 1996-09-23 |
| Decision Date | 1996-10-29 |