The following data is part of a premarket notification filed by Shanghai Foremost Plastic Industrial Co., Ltd. with the FDA for Vinyl Patient Examination Glove, Powdered.
| Device ID | K971423 |
| 510k Number | K971423 |
| Device Name: | VINYL PATIENT EXAMINATION GLOVE, POWDERED |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD. YAN LIN ROVER BRIDGE EAST CHE XING HWY. CHE DUN TOWN Songjiang County, Shanghai, CN 201611 |
| Contact | Tiang S Chang |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1997-04-17 |
| Decision Date | 1997-05-23 |
| Summary: | summary |