FDA applicant
Mrk Healthcare Pvt, Ltd.
FDA records 1 decision for Mrk Healthcare Pvt, Ltd. (Patan, IN) in 2021: 1 510(k) clearance. All are in product code KGO (Surgeon'S Gloves). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Mrk Healthcare Pvt, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2021high 1 (2021) · low 0 (2022)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Mrk Healthcare Pvt, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report