Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kanam Latex Industries Pvt. , Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
104 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052214 | PRE-POWDERED STERILE EXAM GLOVES | Kanam Latex Industries Pvt. , Ltd. | 2005-09-13 | 29 | 0 |
| K033564 | POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WIT | Kanam Latex Industries Pvt. , Ltd. | 2004-02-24 | 104 | 0 |
| K013914 | POWDERFREE LATEX SURGEON'S GLOVES | Kanam Latex Industries Pvt. , Ltd. | 2002-02-06 | 71 | 0 |
| K904972 | SURGICARE STERILE SURGICAL GLOVES | Kanam Latex Industries Pvt. , Ltd. | 1991-01-31 | 99 | 0 |
| K897139 | LATEX PATIENT EXAMINATION GLOVES | Kanam Latex Industries Pvt. , Ltd. | 1990-01-23 | 27 | 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