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510(k) K243967

ONE Nitrile Condom by Global Protection Corp. — Product Code MOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2025
Date Received
December 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom, Synthetic
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

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