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K Number
K994432
Device Name
HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS)
Manufacturer
HWA TEH INDUSTRIAL SDN. BHD.
Date Cleared
2000-02-16

(48 days)

Product Code
LYY
Regulation Number
880.6250
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Device Description

HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS)

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for "HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS)". This document confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the information required to answer your specific questions about acceptance criteria and the study that proves the device meets the acceptance criteria is not present in the provided document.

This 510(k) letter is a regulatory approval document and typically summarizes the FDA's decision based on information provided in the 510(k) submission. It does not elaborate on the specific test methods, sample sizes, ground truth establishment, or detailed study results that were part of that submission.

Therefore, I cannot extract the following information from the given text:

  1. A table of acceptance criteria and the reported device performance: This detailed data is not in the approval letter.
  2. Sample size used for the test set and the data provenance: Not specified.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
  4. Adjudication method for the test set: Not specified.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, etc.: Not specified.
  6. If a standalone study (algorithm only without human-in-the-loop performance) was done: Not specified (this device is a physical glove, not an algorithm, so this question is not applicable in its current form).
  7. The type of ground truth used: Not specified.
  8. The sample size for the training set: Not specified (not applicable for this type of device).
  9. How the ground truth for the training set was established: Not specified (not applicable for this type of device).

To obtain this information, one would typically need to review the full 510(k) submission document, which would include the detailed testing protocols and results that led to the FDA's substantial equivalence determination.

§ 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.