The following data is part of a premarket notification filed by Shijiazhuang Hongxiang Plastics Products Co., Ltd with the FDA for Powder Free Sterile Vinyl Glove (clear And Yellow).
| Device ID | K053523 |
| 510k Number | K053523 |
| Device Name: | POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD 3973 SCHAEFER AVE. Chino, CA 91710 |
| Contact | Micky Lin |
| Correspondent | Micky Lin SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD 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 | 2005-12-19 |
| Decision Date | 2006-02-14 |
| Summary: | summary |