KNIGHT LIGHT NONLUBRICATED CONDOM by GLOBAL PROTECTION CORP.

KNIGHT LIGHT™ CONTRACEPTIVES, if properly used, are intended to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases. In addition, if properly used, KNIGHT LIGHT™ CONTRACEPTIVES can reduce the risk of pregnancy.

Device Description

Latex Condoms with Fluorescent Pigment (Knight Light®; KL 101)

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth for a medical device. The document is a 510(k) clearance letter from the FDA for "Latex Condoms with Fluorescent Pigment (Knight Light®; KL 101)", indicating that the device has been found substantially equivalent to a predicate device.

The information primarily discusses:

Device Name: Latex Condoms with Fluorescent Pigment (Knight Light®; KL 101)
510(k) Number: K960552
Regulatory Class: II
Product Code: 85 HIS
Indications For Use: Reducing the risk of HIV infection (AIDS), other sexually transmitted diseases, and pregnancy (when properly used).
Classification: Over-The-Counter Use

There are no details about specific performance metrics, clinical study designs, sample sizes, expert qualifications, or ground truth establishment. This type of information is usually found in the 510(k) premarket notification submission itself, which is not provided here.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 20 1997

Mr. Davin Wedel Global Protection Corporation 323 New Boston Street, #2 Wilmington, Massachusetts 01887 Re: K960552

Latex Condoms with Fluorescent Pigment (Knight Light®; KL 101) Dated: August 28, 1997 Received: September 2, 1997 Regulatory class: II 21 CFR §884.5300/Product code: 85 HIS

Dear Mr. Wedel:

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, 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Wiliau Yu

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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Indications For Use Statement

510(k) Number if known): K960552

Device Name: KNIGHT LIGHT™ CONTRACEPTIVES

Indications For Use:

(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	K960552

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

The-Counter Use _1/

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.