LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN)

• K Number: K991777
• Device Name: LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN)
• Manufacturer: SELTOM PACIFIC SDN. BHD.
• Date Cleared: 1999-08-31 ( 98 days)
• Product Code: LYY , JUL
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.

Device Description

LATEX Powder Free Patient Examination Gloves with A PROTEIN LABELING CLAIM 2 50 MICROGRAMS OF TOTAL EXTRACTABLE PROTETH

AI/ML Overview

The provided text is a letter from the FDA regarding the clearance of a medical device, specifically "Latex Examination Gloves Powder-Free with Trade Name: Protein Labeling Claim (50 Micrograms or Less Total Extractable Protein)".

This document is a regulatory approval letter and does not contain the information requested regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the product code and the indications for use.

To answer your questions, one would need to refer to the actual 510(k) submission (K991777) or related testing documentation, which is not present in 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.