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.
| Device ID | K142409 |
| 510k Number | K142409 |
| Device Name: | Vinyl Co-Polymer Powder Free Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | GRAND WORK PLASTIC PRODUCTS CO., LTD. DONGGAO INDUSTRIAL ZONE ZANHUANG Zanhuang County, CN 050000 |
| Contact | Deng Zhanyong |
| Correspondent | Kathy Liu HONGRAY USA MEDICAL PRODUCTS INC 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 | 2014-08-27 |
| Decision Date | 2014-12-05 |
| Summary: | summary |