Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Armor Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
252 daysmedian FDA review time
310 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923229 | MEDARMOR FINGER TIP, PUNCTURE RESISTANT UNDERGLOVE | Medical Armor Corp. | 1993-05-07 | 310 | 0 |
| K912737 | MEDARMOR FINGERTIP, PUNC/CUT RESIST SURG EXAM GLOV | Medical Armor Corp. | 1991-10-08 | 109 | 0 |
| K912457 | MEDARMOR FINGERTIP, PUNCTURE AND CUT RESISTANT GLO | Medical Armor Corp. | 1991-10-04 | 123 | 0 |
| K880440 | PROTECT-AIDS AUTOPSY UNDERGLOVE | Medical Armor Corp. | 1988-10-11 | 252 | 0 |
| K880439 | PROTECT-AIDS UNDERGLOVE | Medical Armor Corp. | 1988-10-11 | 252 | 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