The following data is part of a premarket notification filed by Zhangjiagang Huayuan Plastic Co., Ltd. with the FDA for Prime Protection Powdered Vinyl Examination Gloves.
| Device ID | K070519 |
| 510k Number | K070519 |
| Device Name: | PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZHANGJIAGANG HUAYUAN PLASTIC CO., LTD. INDUSTRIAL CONCENTRATION DISTRICT TANGQIAO Zhangjiagang City, Jiangsu, CN 215615 |
| Contact | Y. T Yeo |
| Correspondent | Y. T Yeo ZHANGJIAGANG HUAYUAN PLASTIC CO., LTD. INDUSTRIAL CONCENTRATION DISTRICT TANGQIAO Zhangjiagang City, Jiangsu, CN 215615 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-22 |
| Decision Date | 2007-04-10 |