The following data is part of a premarket notification filed by Hong Di Plastic Products Co, Ltd. with the FDA for Powder Free Vinyl Patient Examination Glove.
| Device ID | K070187 |
| 510k Number | K070187 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | HONG DI PLASTIC PRODUCTS CO, LTD. 3973 SCHAEFER AVE. Chino, CA 91710 |
| Contact | Kathy Liu |
| Correspondent | Kathy Liu HONG DI PLASTIC 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 | 2007-01-22 |
| Decision Date | 2007-02-13 |
| Summary: | summary |