Male Latex Condoms
K-Number: K162919 · 2017-03-07
Decision Date2017-03-07
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Male Latex Condoms is a medical device manufactured by Zhejiang Xiangban Latex Products Co., Ltd.. It received FDA 510(k) clearance on 2017-03-07 under approval number K162919. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Male Latex Condoms?
Male Latex Condoms is a medical device that received FDA 510(k) clearance on 2017-03-07. It is manufactured by Zhejiang Xiangban Latex Products Co., Ltd.. The 510(k) number is K162919.
When was Male Latex Condoms approved by the FDA?
Male Latex Condoms received FDA 510(k) clearance on 2017-03-07, under approval number K162919.
What company makes Male Latex Condoms?
Male Latex Condoms is manufactured by Zhejiang Xiangban Latex Products Co., Ltd..
What is the FDA product code for Male Latex Condoms?
The FDA product code for Male Latex Condoms is HIS.
Related Devices (Code: HIS)
K153016aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products , Ltd.
K161915Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe LubricantChurch & Dwight Co., Inc.
K161545Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe LubricantChurch & Dwight Co., Inc.
K161195Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)M3 Global Enterprises, LLC
K160644Lelo Hex Natural Rubber Latex CondomLelo, Inc.
K172414JUD custom fit condomGlobal Mailer Partners, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.