The following data is part of a premarket notification filed by Shijiazhuang Hongxiang Plastics Products Co; Ltd. with the FDA for Synthetic Powdered (white) Vinyl Patient Examination Gloves.
| Device ID | K001863 |
| 510k Number | K001863 |
| Device Name: | SYNTHETIC POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO; LTD. 12390 EAST END AVE. Chino, CA 91710 |
| Contact | James Chu |
| Correspondent | James Chu SHIJIAZHUANG HONGXIANG PLASTICS 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 | 2000-06-19 |
| Decision Date | 2000-07-11 |