SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES

• K Number: K981348
• Device Name: SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES
• Manufacturer: SMART GLOVE CORP. SDN BHD
• Date Cleared: 1998-05-18 ( 38 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

SMARTTEX Pre Powdered Latex Examination Glove Natural. IIE E (AREEN

AI/ML Overview

The provided FDA 510(k) clearance letter (K981348) for "Smarttex PrePowdered Latex Examination Gloves"does not contain any information regarding acceptance criteria, device performance studies, or details about artificial intelligence (AI) or machine learning (ML) algorithms.

This clearance is for a class I medical device (latex examination gloves), which are typically subject to general controls and a substantial equivalence review. For such devices, the FDA primarily evaluates whether the device is as safe and effective as a legally marketed predicate device. This usually involves demonstrating equivalence through performance testing related to barrier integrity (e.g., pinhole tests), physical properties (e.g., tensile strength, elongation), and biocompatibility, rather than clinical studies with ground truth established by experts or AI performance metrics.

Therefore, I cannot answer your specific questions about:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study with AI.
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 document is a regulatory clearance letter for a physical medical device (gloves) and does not concern an AI/ML-driven device.

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.