SHEER THIN

K984488 · Twe Companies, Inc. · HIS · Feb 1, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K984488
• Device Name: SHEER THIN
• Applicant: Twe Companies, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Feb 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The Sheer Thin condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases.

Device Story

Sheer Thin is a natural rubber latex sheath designed to cover the penis. It features a straight-shafted, nipple-end design with a nominal width of 52 mm, length of 180 mm, and thickness of 0.060 mm. The device is intended for over-the-counter use for contraception and the prevention of sexually transmitted diseases. It functions as a physical barrier.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material composition, and conformance to ASTM standards.

Technological Characteristics

Natural rubber latex sheath; straight-shafted, nipple-end design; 52 mm width, 180 mm length, 0.060 mm thickness. Conforms to ASTM Latex Condom Standard D-3492.

Indications for Use

Indicated for contraception and prevention of pregnancy and sexually transmitted diseases in individuals using condoms.

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.

Predicate Devices

• Trojan Ultra Thin (K912901)

Submission Summary (Full Text)

{0}------------------------------------------------

K9844488

FEB 1 1935

## 510(k) Summary

| Submitted By: | TWE Companies, Inc.<br>46 Franklin Street<br>P.O. Box 23<br>Avondale Estates, GA 30002<br>Phone [phone] |
|---------------|----------------------------------------------------------------------------------------------------------------|
|---------------|----------------------------------------------------------------------------------------------------------------|

Keith F. Heintz Contact Person:

Date Prepared: December 16, 1998

Proprietary Name: Sheer Thin

Latex Condom Common Name:

Classification Name: Condom

Trojan Ultra Thin Predicate Device: 510(k) #K912901

The condom is made of a natural rubber latex sheath, which Description of the Device: completely covers the penis with a closely fitted membrane. This condom is straight shafted, nipple end condom having a nominal width of 52 mm, nominal length of 180 mm and nominal thickness of 0.060 mm.

Intended Use of the Device: This latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases.

Technological Characteristics: This condom made of natural rubber and is similar in design and composition to the predicate condom identified above. The design is in conformance with the ASTM Latex Condom Standard D-3492. The condom is fitted over the penis as is the predicate device and is of similar nominal measurements to the predicate condom.

{1}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1999

Mr. Keith Heintz Vice President TWE Companies, Inc. 46 Franklin Street P.O. Box 23 Avondale Estates, GA 30002

K984488 Re: Sheer Thin - Natural Rubber Latex Condom Dated: December 16, 1998 Received: December 17, 1998 Regulatory Class: II 21 CFR 884.5300/Procode: 85 HIS

Dear Mr. Heintz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR 884.5300 and 884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435. Therefore, an expiration date, supported by test data developed under the conditions specified in 801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the expiration dates. Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, 801.435(e) requires that if your real-time to confirm the shelf life estimated by the methods in 801.435(d), then you must relabel all product to reflect the actual shelf life. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.

{2}------------------------------------------------

## Page 2 - Mr. Keith Heintz

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone],or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

.

CAPT. Daniel C. Schul

ČAPT. Daniel G. Schultz, M.D. Acting Director Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{3}------------------------------------------------

## Indications for Use Statement

| 510(k) Number: | K984488 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Sheer Thin - Natural Rubber Latex Condom |
| Indications for Use: | The Sheer Thin condom is used for contraception and for<br>prophylactic purposes to help prevent pregnancy and the<br>transmission of sexually transmitted diseases. |

(LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Proscription Use (Per 21 CFR §801.109) OR Over-The-Counter Use

s.ter

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 84488 510(k) Number