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Global Protection Corp.

Lynn, MA, US

GLOBAL PROTECTION CORP. appears in FDA device records in Lynn, MA. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 11 510(k) clearances for Global Protection Corp. between 1997 and 2025. The busiest year on record is 2025, with 3. The most recent is 2025, with 3.

Clearances by year, as a table
510(k) clearance decisions for Global Protection Corp., by decision year
YearClearances
19971
20031
20201
20211
20222
20231
20241
20253
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K250142Water-based LubricantNUCSubstantially Equivalent
K243972Plain Water-based LubricantNUCSubstantially Equivalent
K243967ONE Nitrile CondomMOLSubstantially Equivalent
K240896ONE Nitrile CondomMOLSubstantially Equivalent
K223214Powder-Free Nitrile Examination GlovesLZASubstantially Equivalent
K213087Natural Rubber Latex Ultrasound Transducer Probe CoversITXSubstantially Equivalent
DEN210034ONE Male CondomQRZUnknown
K203536Male Latex CondomHISSubstantially Equivalent
K193578Non-spermicidal Lubricated Male Latex CondomHISSubstantially Equivalent
K024324LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9HISSubstantially Equivalent
K960552KNIGHT LIGHT NONLUBRICATED CONDOMHISSubstantially Equivalent

Registered establishments

FDA registered establishments for Global Protection Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
12221151222115GLOBAL PROTECTION CORP.630 Lynnway, Lynn, MA 01905 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0054-2008Lubricated Latex Condom. Labeled in part: "COMING TOGETHER IN DC", Distributed by Global Protection Corp., #12 Channel Street, Boston, MACondoms fail the water leak test and package integrityTerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain