DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR

• K Number: K013753
• Device Name: DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
• Manufacturer: CANOPUS MEDICAL SUPPLY CO., LTD.
• Date Cleared: 2001-12-10 ( 27 days)
• Product Code: LYZ
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

DISPOSABLE PATIENT EXAMINATION GLOVES IS A DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER, FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER, FOR MEDICAL PURPOSES WORN ON THE BRINESE

Device Description

Disposable Powder Free Vinyl Synthetic Examination Gloves, White

AI/ML Overview

This FDA document, K013753, is for "Disposable Powder Free Vinyl Synthetic Examination Gloves, White". It is a 510(k) premarket notification indicating substantial equivalence to a predicate device. This type of submission, for a Class I device like examination gloves, does not typically include detailed clinical studies with specific acceptance criteria, sample sizes, or ground truth methodologies as would be found for more complex diagnostic or AI-driven medical devices.

Therefore, I cannot provide the requested information in the format of the table or answer the specific questions (2-9) because the source document does not contain this type of data.

Here's why:

• Device Type: Examination gloves are Class I devices. Their substantial equivalence is usually demonstrated through meeting recognized consensus standards for material properties, sterility (if applicable), and physical performance (e.g., tensile strength, barrier integrity).
• 510(k) Process for Class I Devices: For many Class I devices, the 510(k) submission primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through bench testing and adherence to standards, rather than complex clinical trials involving patient outcomes or expert interpretations. The "performance data" for such devices would typically be laboratory test results against established ASTM or ISO standards.

If this were an AI-driven diagnostic device, the requested information would be highly relevant and often found in the 510(k) summary or associated documents. However, for a Class I examination glove, the information you're asking for isn't part of the regulatory review process in the same way.

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.