Who is the manufacturer of RIA LATEX CONDOM?

Mbf Personal Care Sdn. Bhd. submitted the Traditional clearance for RIA LATEX CONDOM (K943880).

What is the FDA product code for RIA LATEX CONDOM?

HIS. It is classified under 21 CFR 884.5300 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for RIA LATEX CONDOM?

510(k) clearance (submission type: Traditional).

RIA LATEX CONDOM

K943880 · Mbf Personal Care Sdn. Bhd. · HIS · Feb 13, 1996 · Obstetrics/Gynecology

Device Facts

Record ID	K943880
Device Name	RIA LATEX CONDOM
Applicant	Mbf Personal Care Sdn. Bhd.
Product Code	HIS · Obstetrics/Gynecology
Decision Date	Feb 13, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.5300
Device Class	Class 2

Regulatory Classification

Identification

A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.

Special Controls

*Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.