The following data is part of a premarket notification filed by Weifang Beihai Color Printing Packagging Co., Ltd with the FDA for Synthetic Vinyl Examination Glove, Powder Free.
| Device ID | K110224 |
| 510k Number | K110224 |
| Device Name: | SYNTHETIC VINYL EXAMINATION GLOVE, POWDER FREE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | WEIFANG BEIHAI COLOR PRINTING PACKAGGING CO., LTD NO 366. YUEHE ROAD WEICHENG DISTRICT Weifang, Shandong, CN 261021 |
| Contact | Haiqi Zhang |
| Correspondent | Haiqi Zhang WEIFANG BEIHAI COLOR PRINTING PACKAGGING CO., LTD NO 366. YUEHE ROAD WEICHENG DISTRICT Weifang, Shandong, CN 261021 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-25 |
| Decision Date | 2011-03-18 |