Who is the manufacturer of MALE LATEX COMDOM WITH DOTTED SURFACE?

Pleasure Latex Products Sdn. Bhd. submitted the Abbreviated clearance for MALE LATEX COMDOM WITH DOTTED SURFACE (K001221).

What is the FDA product code for MALE LATEX COMDOM WITH DOTTED SURFACE?

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 MALE LATEX COMDOM WITH DOTTED SURFACE?

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

MALE LATEX COMDOM WITH DOTTED SURFACE

K001221 · Pleasure Latex Products Sdn. Bhd. · HIS · May 19, 2000 · Obstetrics/Gynecology

Device Facts

Record ID	K001221
Device Name	MALE LATEX COMDOM WITH DOTTED SURFACE
Applicant	Pleasure Latex Products Sdn. Bhd.
Product Code	HIS · Obstetrics/Gynecology
Decision Date	May 19, 2000
Decision	SESE
Submission Type	Abbreviated
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.