Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shanghai Antares Industries, Inc. · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
74 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052612 | DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLE | Shanghai Antares Industries, Inc. | 2005-11-22 | 61 | 0 |
| K021853 | DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR, POWDER FR | Shanghai Antares Industries, Inc. | 2002-08-01 | 56 | 0 |
| K020943 | STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE | Shanghai Antares Industries, Inc. | 2002-06-06 | 73 | 0 |
| K012499 | ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES | Shanghai Antares Industries, Inc. | 2001-10-16 | 74 | 0 |
| K012339 | ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, Y | Shanghai Antares Industries, Inc. | 2001-10-16 | 84 | 0 |
| K003321 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WI | Shanghai Antares Industries, Inc. | 2000-11-22 | 29 | 0 |
| K000953 | DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR | Shanghai Antares Industries, Inc. | 2000-04-20 | 27 | 0 |
| K000872 | DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE CO | Shanghai Antares Industries, Inc. | 2000-04-05 | 16 | 0 |
| K993049 | DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES | Shanghai Antares Industries, Inc. | 1999-11-19 | 70 | 0 |
| K992017 | DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE | Shanghai Antares Industries, Inc. | 1999-08-05 | 51 | 0 |
| K983532 | POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COL | Shanghai Antares Industries, Inc. | 1998-11-30 | 53 | 0 |
| K983531 | POWDERED NITRILE MEDICAL EXAMINATION GLOVE, COLORED | Shanghai Antares Industries, Inc. | 1998-11-30 | 53 | 0 |
| K982687 | DISPOSABLE VINYL EXAM GLOVES, POWDERED | Shanghai Antares Industries, Inc. | 1998-10-09 | 67 | 0 |
| K982704 | DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE | Shanghai Antares Industries, Inc. | 1998-09-30 | 58 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda