The following data is part of a premarket notification filed by Weilin Plastic And Rubber Products Co., Ltd. with the FDA for Vinyl Examination Powder Free Gloves, Clear.
| Device ID | K123590 |
| 510k Number | K123590 |
| Device Name: | VINYL EXAMINATION POWDER FREE GLOVES, CLEAR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | WEILIN PLASTIC AND RUBBER PRODUCTS CO., LTD. 12390 EAST END AVE. Chino, CA 91710 |
| Contact | Ling Zhu |
| Correspondent | Ling Zhu WEILIN PLASTIC AND RUBBER 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 | 2012-11-21 |
| Decision Date | 2013-06-17 |
| Summary: | summary |