Search Results

THE [No particular brand name] condom is used for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Male Natural Rubber Latex Condom

This document discusses the FDA's acceptance of a 510(k) premarket notification for a male natural rubber latex condom. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Such information would typically be detailed in the 510(k) submission itself, which this letter is a response to, rather than the approval letter.

Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth, as none of that information is present in the provided text.

Ask a specific question about this device

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

This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled or contoured with a reservoir tip; nominal length 180mm, nominal width 52mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. This condom is colored and flavored, and designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.

The provided text describes a 510(k) premarket notification for a Male Latex Condom and does not contain information about acceptance criteria, device performance, or a study proving it meets acceptance criteria for an AI/ML medical device. This document is related to a physical medical device (condom) and discusses its characteristics and intended use, comparing it to predicate devices.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Ask a specific question about this device

The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Ultra Thick Male Latex Condom with Silicone Lubricant

The provided document is a 510(k) clearance letter from the FDA for a male latex condom. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on the substantial equivalence determination for regulatory clearance.

Therefore, I cannot extract the requested information from this document.

Ask a specific question about this device

The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device:

• Device Name: Ultra Thin Latex Condom with Silicone Lubricant
• Applicant: INNOLATEX SDN. BHD.
• Date of Letter: November 9, 2001
• FDA Product Code: 85 HIS
• Regulation Number: 21 CFR 884.5300
• Regulation Name: Condom

Based on the provided text, there is no information regarding acceptance criteria for device performance, any specific study proving the device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or the type of ground truth used.

The document is a regulatory clearance letter stating that the device is substantially equivalent to a legally marketed predicate device. It discusses general controls, additional controls for Class II/III devices, good manufacturing practices, labeling requirements (including expiration dating for latex condoms), and contact information for regulatory inquiries.

The "INDICATIONS FOR USE STATEMENT" at the end confirms that the "Male Natural Rubber Latex Condom" (with no particular brand name specified in the provided text in that section) is indicated for contraception and prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted diseases).

Therefore, I cannot provide the requested information as it is not present in the given document.

Ask a specific question about this device

The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Not Found

The provided text is a 510(k) clearance letter from the FDA for a male natural rubber latex condom. It does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. While it mentions regulatory compliance and substantial equivalence to a predicate device, it does not describe performance metrics or study designs typically associated with AI/ML device evaluations.

Therefore, I cannot fulfill your request for the specific details outlined as they are not present in this document.

However, I can extract the information that is available:

Device Name: Male Natural Rubber Latex Condom
Indications For Use: Contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Regulatory Class: II
Product Code: 85 HIS
Regulation Number: 21 CFR 884.5300
Regulation Name: Condom

The document primarily focuses on:

• Confirming the device's substantial equivalence to a legally marketed predicate device.
• Outlining general controls provisions and potential additional controls for Class II devices.
• Emphasizing compliance with labeling regulations, specifically regarding expiration dating for latex condoms (21 CFR §801.435).

To answer your questions, I would need a different type of document, such as a clinical study report or a 510(k) submission detailing the performance evaluation of an AI-powered device.

Ask a specific question about this device

The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Not Found

The provided document is a 510(k) clearance letter from the FDA for a Dotted Condom, Male Natural Rubber Latex Condom. It does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria.

The letter explicitly states:

• "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."

This indicates that while the manufacturer must have data to support the device's shelf life and performance, this specific FDA clearance letter does not include the details of those studies or acceptance criteria.

Therefore, I cannot provide the requested information from this document.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device