POWDERFREE LATEX EXAMINATION GLOVES

• K Number: K974832
• Device Name: POWDERFREE LATEX EXAMINATION GLOVES
• Manufacturer: SERVICOM SERVICES SDN BHD
• Date Cleared: 1998-02-11 ( 49 days)
• Product Code: LYY
• 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 health care personnel and patient. It is a single use disposable gloves.

Device Description

Powderfree Latex Examination Gloves with Trade Name: Protein Content Labeling Claim (50 Micrograms of Less)

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for "Powderfree Latex Examination Gloves with Trade Name: Protein Content Labeling Claim (50 Micrograms of Less)" manufactured by Servicom Services Sdn. Bhd. It does not contain the detailed information necessary to answer the questions about acceptance criteria for a medical device's performance study.

The letter acknowledges the submission and states that the device is substantially equivalent to a legally marketed predicate device. The "Indications For Use" attachment specifies that the medical glove is used to prevent contamination between healthcare personnel and patients, and that it is a single-use disposable glove.

The document does not include:

1. A table of acceptance criteria or reported device performance.
2. Sample size, data provenance, or details of a test set.
3. Information on experts or ground truth establishment.
4. Adjudication methods.
5. Details of a multi-reader multi-case (MRMC) comparative effectiveness study, as it's not relevant for this type of device.
6. Information on standalone algorithm performance (as it's not an algorithmic device).
7. The type of ground truth used (as it's not an AI/diagnostic device).
8. Sample size for a training set (as it's not an AI/diagnostic device).
9. How ground truth for a training set was established (as it's not an AI/diagnostic device).

Therefore, I cannot provide the requested information 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.