Global Protection Corp.

Medical device manufacturer in Boston, MA.

10510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K250142Water-based LubricantNUC · Traditional 08/08/2025SE
K243972Plain Water-based LubricantNUC · Traditional 08/08/2025SE
K243967ONE Nitrile CondomMOL · Traditional 04/08/2025SE
K240896ONE Nitrile CondomMOL · Traditional 08/23/2024SE
K223214Powder-Free Nitrile Examination GlovesLZA · Abbreviated 09/21/2023SE
K213087Natural Rubber Latex Ultrasound Transducer Probe CoversITX · Traditional 06/07/2022SE
K203536Male Latex CondomHIS · Abbreviated 09/03/2021SE
K193578Non-spermicidal Lubricated Male Latex CondomHIS · Abbreviated 08/20/2020SE
K024324Latex Condom and Latex Condom Lubricated with NONOXYNOL-9HIS · Abbreviated 03/25/2003SE
K960552Knight Light Nonlubricated CondomHIS · Traditional 11/20/1997SE

Recalls

RecallProductInitiated
Z-0054-2008 Lubricated Latex Condom. Labeled in part: "COMING TOGETHER IN DC", Distributed by Global…Condoms fail the water leak test and package integrity 09/11/2007Terminated