510(k) K221906

TROJAN Fire & Ice lubricated male natural rubber latex condom by Church & Dwight Co., Inc. — Product Code HIS

K221906 is an FDA 510(k) premarket notification submitted by Church & Dwight Co., Inc. for the device "TROJAN Fire & Ice lubricated male natural rubber latex condom". The FDA issued a decision of Substantially Equivalent on September 28, 2022. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Church & Dwight Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2022
Date Received
June 30, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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