POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE)

• K Number: K050598
• Device Name: POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE)
• Manufacturer: SMART GLOVE CORP. SDN BHD
• Date Cleared: 2005-04-07 ( 29 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: K020598

Intended Use

Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs (Blue) is a disposable device intended for Medical Purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This davice also provides protection against exposure to certain chemotherapy drugs.

Device Description

Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs (Blue)

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (Blue)". It does not contain information about acceptance criteria or a study proving the device meets said criteria.

Instead, the letter establishes that the device is "substantially equivalent" to legally marketed predicate devices and therefore can be marketed, subject to general controls. It also outlines regulatory requirements, but it does not detail any specific performance acceptance criteria or a study report.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample sized used for the test set and the data provenance: This information is not present in the document because no specific study results are detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the document.
4. Adjudication method: This information is not present in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present in the document.
6. If a standalone performance (algorithm only) study was done: This information is not present in the document, as it pertains to a physical medical device (gloves), not an algorithm.
7. The type of ground truth used: This information is not present in the document.
8. The sample size for the training set: This information is not present in the document.
9. How the ground truth for the training set was established: This information is not present in the document.

The document primarily focuses on the regulatory clearance process for a medical device (nitrile examination gloves) and its "Indications for Use," which states: "Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs (Blue) is a disposable device intended for Medical Purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs."

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.