Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Sanrea Healthcare Private Limited · Predicate Candidate Screening

4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K023910STERILE PATIENT POWDERFREE LATEX EXAMINATION GLOVESSanrea Healthcare Private Limited2003-02-11780
K023912POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS Sanrea Healthcare Private Limited2003-02-11780
K023915STERILE POWDERED LATEX PATIENT EXAMINATION GLOVESSanrea Healthcare Private Limited2003-02-11780
K023515PRE-POWDERED LATEX SURGEON'S GLOVESSanrea Healthcare Private Limited2003-01-16870

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