The following data is part of a premarket notification filed by Shanghai Antares Industries, Inc. with the FDA for Disposable Powder Free Vinyl Exam Gloves With Vitamin Complex, Nopal And Lanolin Blue Color.
| Device ID | K052612 |
| 510k Number | K052612 |
| Device Name: | DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANGHAI ANTARES INDUSTRIES, INC. 259 YUSHU RD., CANGQIAO TOWNSHIP Songjiang County, Shanghai, CN 201600 |
| Contact | John Lai |
| Correspondent | John Lai SHANGHAI ANTARES INDUSTRIES, INC. 259 YUSHU RD., CANGQIAO TOWNSHIP Songjiang County, Shanghai, CN 201600 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-22 |
| Decision Date | 2005-11-22 |
| Summary: | summary |