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K Number
K960552
Device Name
KNIGHT LIGHT NONLUBRICATED CONDOM
Manufacturer
GLOBAL PROTECTION CORP.
Date Cleared
1997-11-20

(651 days)

Product Code
HIS
Regulation Number
884.5300
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

§ 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.