Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Healthgard Medical Products Ltd. Partnership · 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) |
|---|---|---|---|---|---|
| K893149 | PLYMOUTH & LAWANA EXAM GLOVES | Healthgard Medical Products Ltd. Partnership | 1989-06-09 | 26 | 0 |
| K893148 | ALMATEX EXAM GLOVES (MFG. CONCEPT RUBBER) | Healthgard Medical Products Ltd. Partnership | 1989-06-06 | 53 | 0 |
| K893150 | PLYMOUTH & LAWANA EXAM GLOVES | Healthgard Medical Products Ltd. Partnership | 1989-06-02 | 49 | 0 |
| K891748 | ALMATEX PATIENT EXAMINATION GLOVES (LATEX) | Healthgard Medical Products Ltd. Partnership | 1989-05-12 | 51 | 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