Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Seal Co. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
105 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972227 | SHOE COVER | American Seal Co. | 1997-09-09 | 88 | 0 |
| K972187 | BOUFFANT CAP | American Seal Co. | 1997-09-09 | 91 | 0 |
| K970814 | NON-STERILE ISOLATION GOWN | American Seal Co. | 1997-05-27 | 82 | 0 |
| K964358 | AMSEAL SURGICAL FACE MASK | American Seal Co. | 1997-02-14 | 105 | 1 |
| K892557 | MAYTEX NON-STERILE LATEX EXAM GLOVE | American Seal Co. | 1989-05-31 | 51 | 0 |
| K892553 | MAYTEX PATIENT EXAMINATION GLOVES | American Seal Co. | 1989-05-25 | 45 | 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