FDA applicant
Global Protection Corp.
FDA records 11 decisions for Global Protection Corp. (Boston, MA) from 1997 to 2025: 10 510(k) clearances and 1 De Novo grant. Most are in product codes HIS (Condom) and MOL (Condom, Synthetic). Since 2016 its 510(k)s took a median of 235 days from receipt to decision, against 227 for FDA’s reviews in the same codes and years. 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 Global Protection Corp.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Global Protection Corp.’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