510(k) K222611
K222611 is an FDA 510(k) premarket notification submitted by Suzhou Colour-Way New Material Co., Ltd. for the device "Male Latex Condoms". The FDA issued a decision of Substantially Equivalent on November 28, 2022. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Suzhou Colour-Way New Material Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 28, 2022
- Date Received
- August 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