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Personal Lubricant Ring

Page Type
Product Code
Definition
This device is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, polyurethane, and/or internal condoms.
Physical State
This device consists of a hollow plastic ring filled with a liquid vaginal lubricating solution.
Technical Method
The lubricating solution in the lumen of the ring is released through the wall of the tubing into the vagina, moisturizing and lubricating the vaginal mucosa.
Target Area
This device is intended to be used in the vagina.
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.5300
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5300 Condom

§ 884.5300 Condom.

(a) 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.

(b) 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.

[73 FR 66538, Nov. 10, 2008]

Personal Lubricant Ring

Page Type
Product Code
Definition
This device is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, polyurethane, and/or internal condoms.
Physical State
This device consists of a hollow plastic ring filled with a liquid vaginal lubricating solution.
Technical Method
The lubricating solution in the lumen of the ring is released through the wall of the tubing into the vagina, moisturizing and lubricating the vaginal mucosa.
Target Area
This device is intended to be used in the vagina.
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.5300
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5300 Condom

§ 884.5300 Condom.

(a) 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.

(b) 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.

[73 FR 66538, Nov. 10, 2008]