The following data is part of a premarket notification filed by Shanghai Pm Plastics Enterise Co., Ltd. with the FDA for Vinyl Examination Gloves.
| Device ID | K930266 |
| 510k Number | K930266 |
| Device Name: | VINYL EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANGHAI PM PLASTICS ENTERISE CO., LTD. NO. 258,W.YUSHU RD.& S.HU-HANG RAILWAY, CANGQIAO TOWNSHIP Songjiang Co., Shanghai, CN |
| Contact | Wang Chien-shun |
| Correspondent | Wang Chien-shun SHANGHAI PM PLASTICS ENTERISE CO., LTD. NO. 258,W.YUSHU RD.& S.HU-HANG RAILWAY, CANGQIAO TOWNSHIP Songjiang Co., 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 | 1993-01-19 |
| Decision Date | 1993-11-22 |