Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
P.T. Healthcare Glovindo · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
172 daysmedian FDA review time
240 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021659 | PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING | P.T. Healthcare Glovindo | 2002-08-12 | 84 | 0 |
| K010232 | PRE-POWDERED NITRILE EXAMINATION GLOVES | P.T. Healthcare Glovindo | 2001-09-21 | 240 | 0 |
| K010233 | POWDER FREE NITRILE EXAMINATION GLOVES | P.T. Healthcare Glovindo | 2001-06-22 | 149 | 0 |
| K000838 | DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN | P.T. Healthcare Glovindo | 2000-10-23 | 223 | 0 |
| K974853 | LATEX (POWDER FREE) LOW PROTEIN | P.T. Healthcare Glovindo | 1998-02-09 | 42 | 0 |
| K931406 | POWDER-FREE PATIENT EXAMINATION GLOVES | P.T. Healthcare Glovindo | 1993-10-21 | 216 | 0 |
| K930995 | POWDERED EXAMINATION GLOVES | P.T. Healthcare Glovindo | 1993-08-16 | 172 | 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