Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ganz Industries Sdn. Bhd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954487 | PRE POWDERED LATEX EXAMINATION GLOVES | Ganz Industries Sdn. Bhd. | 1996-03-15 | 170 | 0 |
| K945506 | ACRYLIC DIPPED LATEX EXAMINATION GLOVES | Ganz Industries Sdn. Bhd. | 1995-10-12 | 337 | 0 |
| K945505 | ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE | Ganz Industries Sdn. Bhd. | 1995-08-18 | 282 | 0 |
| K945504 | ACRYLIC DIPPED LATEX EXAMINATION GLOVES - STERILE | Ganz Industries Sdn. Bhd. | 1995-08-18 | 282 | 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