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 Gloves, (blue, White, Pink).
| Device ID | K101132 |
| 510k Number | K101132 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (BLUE, WHITE, PINK) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | HONG DI PLASTIC PRODUCTS CO., LTD. 3973 SCHAEFER AVE Chino, CA 91710 |
| Contact | Jie Liu |
| Correspondent | Jie 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 | 2010-04-22 |
| Decision Date | 2010-07-01 |
| Summary: | summary |