The following data is part of a premarket notification filed by Grand Work Plastic Products Co., Ltd. with the FDA for Grand Work Plastics Products Co., Ltd., Synthetic Vinyl Patient Examination Gloves - Powdered.
| Device ID | K041188 |
| 510k Number | K041188 |
| Device Name: | GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATIENT EXAMINATION GLOVES - POWDERED |
| Classification | Vinyl Patient Examination Glove |
| Applicant | GRAND WORK PLASTIC PRODUCTS CO., LTD. DONGGAO INDUSTRIAL ZONE ZANHUANG Zanhuang County, CN 050000 |
| Contact | James Chu |
| Correspondent | James Chu GRAND WORK PLASTIC PRODUCTS CO., LTD. 590 W. CENTRAL AVE., #D Brea, CA 92821 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-06 |
| Decision Date | 2004-06-01 |
| Summary: | summary |