Class Class II

Natural rubber latex male condom (K250034)

K250034 2025-07-11 Traditional
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Description

Natural rubber latex male condom by Shaoguan Regenex Pharmaceuticals Co., Ltd., an FDA 510(k) cleared obstetrics/gynecology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250034
Clearance Date2025-07-11
Clearance TypeTraditional
Product CodeHIS
Regulation Number884.5300

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