ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS

K981621 · Suretex Prophylactics (India) , Ltd. · LTZ · Jun 19, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K981621
• Device Name: ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
• Applicant: Suretex Prophylactics (India) , Ltd.
• Product Code: LTZ · Obstetrics/Gynecology
• Decision Date: Jun 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of veneral diseases).

Device Story

Latex condom with spermicidal lubricant (nonoxynol-9); sheath design covers penis with closely fitted membrane. Used for contraception and prophylactic purposes. Available in natural and assorted colors. Device is intended for over-the-counter use. Benefits include pregnancy prevention and reduction of venereal disease transmission risk.

Clinical Evidence

No clinical data. Bench testing only, including physical testing, air inflation testing, and color fastness testing per ASTM D3492-96 and ISO 4074 standards.

Technological Characteristics

Latex sheath with nonoxynol-9 spermicidal lubricant. Adheres to ASTM D3492-96 and ISO 4074 (parts 1 and 6). Biocompatibility per FDA modified matrix of ISO-10893. Shelf life of 5 years supported by real-time data.

Indications for Use

Indicated for contraception and the prevention of venereal disease transmission.

Regulatory Classification

Identification

A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).

Predicate Devices

• Suretex Ltd. (K942858A)
• Sime Health Ltd. (K932982)

Submission Summary (Full Text)

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JUN 1 9 1998

K981621

2 pages

# 510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submittted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.

The assigned 510(K) number is :

## 1. Submitter's Identification:

Suretex Prophylactics (India) Limited 74-91, KIADB Industrial Estate, Jigani II Phase. Anekal Taluk Bangalore - 562 106 Tel - 91-80-426 222 Fax - 91-80-426 219

Date summary Prepared: 25th April 1998

- 2. Name of the Device:
Latex Condoms -Spermicidal Lubricant - Natural and assorted colors in Royale brand or in any other private label.

#### 3. Predicate Device Information:

Suretex Ltd., K# 942858A, Latex condoms with Spermicidal Lubricant. Sime Health Ltd., K# 932982, Spermicidal lubricated condoms (Essential, Mi Vida and Jiffi).

#### 4. Device Description

A condom with a spermicidal lubricant is a sheath which covers the penis with a closely fitted membrane with a lubricant that contains a spermicidal agent, nonoxynol-9.

## 5. Intended Use

The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of veneral diseases).

#### 6. Comparison to Predicate Devices:

The Latex condoms in Royale or any other private label - Spermicidal lubricant - cloured or assorted colors, will be identical in all aspects to the

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design, composition (latex) and function to the Sime Health Ltd. Spermicidal Condoms.

The Following voluntary standards were adhered to and their device was tested in accordance with all requirements of these standards.

- a. ASTMD3492-96
- b. ISO 4074, part 1 and part 6
- c. May 1, 1995 FDA biocompatibility guidance, FDA modified matrix of ISO -10893.

All Physical testing, air inflation testing and color fastness testing , including all other in-process, and final release testing, revealed results that conformed to the required specifications. In addition, a shelf life of 5 years is claimed, with real-time testingdata to support such claim.

- 8. Discussion of clinical tests performed
Not applicable.

- 9. Conclusions
The Royale latex condoms or any private labelled condoms - spermicidal lubricant - clored and assorted colors - to be sold by Suretex Prophylactics (India) Ltd, has the same intended use and similar technological characteristics as the Sime Health Ltd. Condoms and identical technological characteristics as the Suretex Ltd. Condom. All non-clinical testing and biocompatibility testing revealed no new questions of safety or effectiveness. Thus, when compared to the predicate devices, the Royale brand condoms or any other private labelled condoms - spermicidal lubricant -colored and assorted colors did not incorporate any significant changes in intended use, method of operations, material, or design that could effect safety or effectiveness.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right, arranged in a stacked formation. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a circular fashion around the left side of the logo, and the text "SERVICES - USA" is arranged in a circular fashion around the right side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN ! 9 1998

Mr. V. V. Ramana Rao Senior Manager (OA) SURETEX Prophylactics (India) LTD. 74 to 91, KIADB Industrial Estate Jigani II Phase Anekal Taluk, BANGALORE - 562 106 Re: K981621

Royale® Brand Latex Condoms Spermicide Lubricant - colored/uncolored (natural, pink, green, yellow, or blue) Dated: April 11, 1998 Received: May 6, 1998 Regulatory Class: II 21 CFR 884.5310/Procode: 85 LTZ

Dear Mr. Rao:

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 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 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 (OS) 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 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%) 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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/dsmaln.html".

Sincerely vours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Royale ® Brand Latex Condoms -Spermicidal Lubricant Colored Device Name: or Assorted Colors

Indications For Usc:

The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of venereal disease). .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF NEEDED)

Concurence of CDRH, Office of Device Evaluation (ODE)

Robert R. Satting/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K98-1621 510(k) Number

Prescription Usc (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Options) Forced 1-2-96)

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