Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Boston Medical Corp. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
273 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981947 | STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE A | Boston Medical Corp. | 1999-03-03 | 273 | 0 |
| K960841 | POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM | Boston Medical Corp. | 1996-08-15 | 170 | 0 |
| K923385 | BOSTON BRAND HYPOALLERGENIC LATEX GLOVES | Boston Medical Corp. | 1992-10-15 | 100 | 0 |
| K911146 | TAN CHONG GLOVE, HYPOALLERGENIC | Boston Medical Corp. | 1991-04-18 | 42 | 0 |
| K910660 | BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC | Boston Medical Corp. | 1991-03-07 | 21 | 0 |
| K904232 | BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC | Boston Medical Corp. | 1990-09-21 | 9 | 0 |
| K891103 | STERILE PATIENT EXAMINATION GLOVE | Boston Medical Corp. | 1989-03-14 | 25 | 0 |
| K890538 | GUARDS LATEX & SAFE-CONTACT EXAMINATION GLOVES | Boston Medical Corp. | 1989-03-10 | 35 | 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