The following data is part of a premarket notification filed by Shanghai Foremost Plastic Industrial Co., Ltd. with the FDA for Powder Free Vinyl Examination Glove.
| Device ID | K032071 |
| 510k Number | K032071 |
| Device Name: | POWDER FREE VINYL EXAMINATION GLOVE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD. 30798 US HWY. 19N Palm Harbor, FL 34684 |
| Contact | William E Harris |
| Correspondent | N. E. Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-07-03 |
| Decision Date | 2003-10-10 |
| Summary: | summary |