Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Northstar Healthcare Holdings · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
170 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122727 | BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE | Northstar Healthcare Holdings | 2013-02-22 | 170 | 0 |
| K122788 | TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE | Northstar Healthcare Holdings | 2013-01-17 | 128 | 0 |
| K123026 | TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH | Northstar Healthcare Holdings | 2012-11-16 | 49 | 0 |
| K122998 | BLUE POWDERED NITRILE EXAMINATION GLOVE | Northstar Healthcare Holdings | 2012-11-06 | 40 | 0 |
| K121926 | BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE W | Northstar Healthcare Holdings | 2012-09-20 | 80 | 0 |
| K121947 | ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES | Northstar Healthcare Holdings | 2012-09-10 | 69 | 0 |
| K121529 | BLACK NITRILE POWDER-FREE EXAMINATION GLOVES | Northstar Healthcare Holdings | 2012-07-12 | 49 | 0 |
| K121464 | BLUE POWER FREE NITRILE EXAMINATION GLOVE | Northstar Healthcare Holdings | 2012-07-05 | 49 | 0 |
| K121506 | UTB BLUE POWDER FREE NITRILE | Northstar Healthcare Holdings | 2012-07-03 | 43 | 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