The following data is part of a premarket notification filed by Shanghai Foremost Plastic Industrial Co., Ltd. with the FDA for Non Sterile Synthetic Powder Free (yellow) Vinyl Patient Examination Gloves.
| Device ID | K041041 |
| 510k Number | K041041 |
| Device Name: | NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD. 13900 49TH STREET NORTH Clearwater, FL 33762 |
| Contact | William E Harris |
| Correspondent | Neil 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 | 2004-04-22 |
| Decision Date | 2004-06-08 |
| Summary: | summary |