The following data is part of a premarket notification filed by Shanxi Hongjin Plastic Technology Co., Ltd with the FDA for Powder Free Vinyl Patient Examination Gloves.
| Device ID | K180381 |
| 510k Number | K180381 |
| Device Name: | Powder Free Vinyl Patient Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Shanxi Hongjin Plastic Technology Co., Ltd Coal Bed Gas Industrial Zone, Qu'e Town, Daning County Linfen City, CN 042399 |
| Contact | Wu Zhigang |
| Correspondent | Kathy Liu Hongray USA Medical Products Inc 3973 Schaefer 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 | 2018-02-12 |
| Decision Date | 2018-11-07 |
| Summary: | summary |