The following data is part of a premarket notification filed by Shijiazhuang Wally Plastics Co., Ltd with the FDA for Pre-powdered Vinyl Exam Gloves.
| Device ID | K041379 |
| 510k Number | K041379 |
| Device Name: | PRE-POWDERED VINYL EXAM GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHIJIAZHUANG WALLY PLASTICS CO., LTD NO 78 TONGDA RD. Jinzhou City, Hebei, CN 052260 |
| Contact | Iris Yang |
| Correspondent | Iris Yang SHIJIAZHUANG WALLY PLASTICS CO., LTD NO 78 TONGDA RD. Jinzhou City, Hebei, CN 052260 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-24 |
| Decision Date | 2004-08-31 |