The following data is part of a premarket notification filed by Shandong Dawei Medical Products Co., Ltd. with the FDA for White Vinyl Exam Gloves Powder Free.
| Device ID | K140322 |
| 510k Number | K140322 |
| Device Name: | WHITE VINYL EXAM GLOVES POWDER FREE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANDONG DAWEI MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE. Chino, CA 91710 |
| Contact | Sophie Hao |
| Correspondent | Sophie Hao SHANDONG DAWEI MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE. Chino, CA 91710 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-10 |
| Decision Date | 2014-06-12 |
| Summary: | summary |