SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES

• K Number: K011717
• Device Name: SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES
• Manufacturer: SUNMAX ENTERPRISE SHANGHAI CO. LTD.
• Date Cleared: 2001-08-14 ( 71 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A powdered patient examination glove is a disposable device made of nitrile for medical purposes that is worn upon the hand to prevent contamination between patient and examiner.

Device Description

Sunmax Blue Nitrile Powdered Examination Gloves

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The text is a 510(k) premarket notification letter from the FDA regarding "Sunmax Blue Nitrile Powdered Examination Gloves." It discusses the substantial equivalence of the gloves to a legally marketed predicate device and confirms that the company can begin marketing them.

The document includes:

• A letter from the FDA approving the 510(k) application (K011717) for the Sunmax Blue Nitrile Powdered Examination Gloves.
• An "Indications For Use Statement" for the gloves, describing them as "a disposable device made for medical purposes to prevent contamination between patient and examiner."

It does not contain:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance, or expert qualifications for ground truth.
• Details on adjudication methods, MRMC studies, or standalone algorithm performance.
• Information about training sets or how their ground truth was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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.