The following data is part of a premarket notification filed by Shandong Huayue Glove Co., Ltd. with the FDA for Vinyl Examination Glove, Powder Free Clear (non-colored).
| Device ID | K090513 |
| 510k Number | K090513 |
| Device Name: | VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANDONG HUAYUE GLOVE CO., LTD. EAST OF YIFAN/NORTH OF NAQI RD Zhangdian, Shandong, CN |
| Contact | Jinyou Lin |
| Correspondent | Jinyou Lin SHANDONG HUAYUE GLOVE CO., LTD. EAST OF YIFAN/NORTH OF NAQI RD Zhangdian, Shandong, CN |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-26 |
| Decision Date | 2009-05-08 |