The following data is part of a premarket notification filed by Grand Work Plastic Products Co., Ltd. with the FDA for Vinyl Co-polymer Powder Free Examination Gloves, Blue Color.
| Device ID | K061562 |
| 510k Number | K061562 |
| Device Name: | VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | GRAND WORK PLASTIC PRODUCTS CO., LTD. DONGGAO INDUSTRIAL ZONE ZANHUANG Zanhuang County, CN 050000 |
| Contact | Kathy Liu |
| Correspondent | Kathy Liu GRAND WORK PLASTIC PRODUCTS CO., LTD. 3973 SCHAFER 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 | 2006-06-05 |
| Decision Date | 2006-07-11 |
| Summary: | summary |