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K Number
K990117
Device Name
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
Manufacturer
SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC.
Date Cleared
1999-02-19

(37 days)

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

A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Device Description

DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE

AI/ML Overview

I apologize, but the provided text from the FDA letter (K990117) does not contain any information about acceptance criteria, device performance metrics, or study details.

This document is a 510(k) clearance letter for "Disposable Vinyl Synthetic Exam Gloves, Powder-Free." It states that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976. The letter primarily addresses:

  • Device Identification: Disposable Vinyl Synthetic Exam Gloves, Powder-Free.
  • Regulatory Classification: Class I, Product Code LYZ.
  • Regulatory Pathway: 510(k) clearance based on substantial equivalence.
  • Indications for Use: "A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner."
  • General Controls: Mentions requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
  • No clinical study data or performance metrics are detailed in this document.

Therefore, I cannot fulfill your request for:

  1. Table of acceptance criteria and reported device performance: Not present.
  2. Sample sizes, data provenance: Not present for performance testing.
  3. Number of experts, qualifications: Not applicable, as no expert review of performance data is mentioned.
  4. Adjudication method: Not applicable.
  5. MRMC comparative effectiveness study: Not present.
  6. Standalone performance: Not present for this type of device and clearance.
  7. Type of ground truth: Not applicable.
  8. Training set sample size: Not applicable.
  9. Ground truth for training set: Not applicable.

This document serves as regulatory clearance based on substantial equivalence, not as a detailed clinical study report or performance validation.

§ 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.