The following data is part of a premarket notification filed by Shandong Zhiwei Medical Products, Co. Ltd. with the FDA for Powder-free Clear Vinyl Patient Examination Gloves.
| Device ID | K171460 |
| 510k Number | K171460 |
| Device Name: | Powder-free Clear Vinyl Patient Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Shandong Zhiwei Medical Products, Co. Ltd. No. 4519 Qingzhou Road Qingzhou, CN 255000 |
| Contact | Carrie Wu |
| Correspondent | Melo Zhang Intco Medical Industries, Inc. 805 Barrington Ave. Ontario, CA 91764 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-18 |
| Decision Date | 2017-09-24 |
| Summary: | summary |