Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hands-On Packaging , Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K892168 | LATEX EXAM GLOVES (SURGICAL TYPE GLOVE) | Hands-On Packaging , Ltd. | 1989-07-14 | 100 | 0 |
| K892169 | PATIENT EXAMINATION GLOVES (LATEX) | Hands-On Packaging , Ltd. | 1989-07-14 | 100 | 0 |
| K872996 | NATURAL-TOUCH (TM) SURGEON'S GLOVE | Hands-On Packaging , Ltd. | 1988-03-04 | 214 | 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