OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS

K994118 · Guilin Latex Factory · HIS · Aug 14, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K994118
• Device Name: OSMANTHUS, KONGFU, AND GOBON, NATURAL RUBBER LATEX CONDOMS
• Applicant: Guilin Latex Factory
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Aug 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Natural rubber latex sheath; designed as closely fitted membrane to cover penis. Used for contraception and prophylaxis against sexually transmitted diseases. Device is over-the-counter product for consumer use.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material conformance to established standards.

Technological Characteristics

Natural rubber latex sheath; straight-walled, nipple-end design. Conforms to ASTM D3492 standard for latex condoms.

Indications for Use

Indicated for use by individuals for contraception and the prevention of sexually transmitted diseases.

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

• Latex Lubricated Condom (K#)
• Latex Condom with Spermicidal Lubricant (K#)

Submission Summary (Full Text)

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# AUG 1 4 2000

### Abbreviated 510 (k) for Male Latex Condoms

| NOTE: Provide the information required by 21 CFR §807.92, |
|-----------------------------------------------------------|
| Content and format for a 510(k) summary (Option 1), below |
| OR |
| the 510(k) Statement (Option 2) on the next page |

The 510(k) Statement-(Option 2) on the next page.

#### 510(k) SUMMARY (Option 1) II. [Refer to 21 CFR \$807.92]

Submitted by:

Guilin Latex Factory Technical Quality Department No.6 Wushan Road, Guilin, Guangxi, China, 541001 Tel: [phone]

Contact Person:

Jiang Youfan

Oct.8,1999

Latex Condom

Date Prepared:

Proprietary Name:

Common Name:

Classification Name:

Condom (21 CFR \$884.5500) and i or Condom with Spennicidal Lubricant (21 CFR 5884.5310)

OSMANTHUS, KONGPY, and GOBON

Predicte Device:

. . .

Latcx Lubricated Condom 510(k) #K (ff=###) and / or

Latex Condom with Spermicidal Lubricant 510(k) #K [#####]

Description of the Device: This condom is made of a naural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom (include a brief description of the vondom, such as, a straight-walled, nipple-end, nominal length, nominal width, nominal thickness, etc]. See Tab 1

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 prognancy and the transmission of sexually transmitted diseases.)

Technological Characteristics: [Indicate whether the condom has the same technological characteristics as the predicate condom identified above. Indicate that the design is in cheriestics as the five Latex Condom Standard D3492 and that the condom is made of Conformance "Miller lates" whilarities and differences of the features and technological characteristics of the condom in comparison to the predicate condom.] See Annex 1

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2000

Guilin Latex Factory c/o Mr. Peter Wei USA Agent 93 Morningside Drive San Francisco, CA 94132 Re: K994118 Osmanthus and Gobon Natural Rubber Latex Condom Dated: May 8, 2000 Received: May 17, 2000 Regulatory Class: II 21 CFR §884.5300/Procode: 85 HIS

Dear Mr. Wei:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we stermined 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, Increfore, 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 (Premattel Aproval), 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 premarkel notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnosic 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" (21CFR 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,

Daniel G. Schultz, M.D.

Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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## 510(k) Number (if known) : K994118

# Device Name: Osmanthus and Gobon Male Natural Rubber Latex Condom

Indications For Use: The Osmanthus and Gobon condom is used for contraception and frunea.chylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Optional Format 3-10-98)

Over-the-Counter Use _