The following data is part of a premarket notification filed by Shanghai Antares Industries, Inc. with the FDA for Powder Free Copolymer Nitrile Medical Examination Glove, Colored.
| Device ID | K983532 |
| 510k Number | K983532 |
| Device Name: | POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COLORED |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANGHAI ANTARES INDUSTRIES, INC. 259 YUSHU RD., CANGQIAO TOWNSHIP Songjiang Shanghai, CN |
| Contact | John Lai |
| Correspondent | John Lai SHANGHAI ANTARES INDUSTRIES, INC. 259 YUSHU RD., CANGQIAO TOWNSHIP Songjiang Shanghai, CN |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-08 |
| Decision Date | 1998-11-30 |