K Number
K212506
Date Cleared
2021-11-07

(90 days)

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

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

Device Description

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large. The subject device is non-sterile.

AI/ML Overview

This document, K212506, is a 510(k) premarket notification for Medical Examination Gloves (Tested for Use with Chemotherapy). It details the acceptance criteria and the study proving the device meets these criteria.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and device performance are primarily based on the ASTM D6319 standard for medical examination gloves and ASTM D6978 for chemotherapy drug permeation.

Test MethodPurposeAcceptance CriteriaReported Device Performance
ASTM D6319Physical Dimensions TestLength (mm): S: ≥220; M/L/XL: ≥230Length: > 240/Pass (implies all sizes met or exceeded)
Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10Width: S: 86-88 /Pass; M: 98-99/ Pass; L: 109-111/ Pass; XL: 115-117/ Pass
Thickness (mm): Finger: ≥0.05; Palm: ≥0.05Finger: 0.11-0.12/Pass; Palm: 0.09-0.10/Pass
ASTM D5151Watertightness Test for Detection of HolesMeet the requirements of ASTM D5151 AQL 2.50/125/Pass (0 defects out of 125 samples, meeting AQL 2.5)
ASTM D6124Powder ContentMeet the requirements of ASTM D6124 240 Minutes
Cyclophosphamide (Cytoxan)20.0 mg/ml(20,000 ppm)> 240 Minutes
Dacarbazine (DTIC)10.0 mg/ml(10,000 ppm)> 240 Minutes
Doxorubicin HCL (Adriamycin)2.0 mg/ml(2,000 ppm)> 240 Minutes
Etoposide (Toposar)20.0 mg/ml(20,000 ppm)> 240 Minutes
Fluorouracil (Adrucil)50.0 mg/ml(50,000 ppm)> 240 Minutes
Paclitaxel (Taxol)6.0 mg/ml(6,000 ppm)> 240 Minutes
Thio TEPA10.0 mg/ml(10,000 ppm)15.2 Minutes

2. Sample Size Used for the Test Set and Data Provenance

  • Sample Size:
    • Watertightness Test (ASTM D5151): 125 samples (0/125/Pass).
    • Other physical performance tests (Dimensions, Physical properties, Powder Content): Specific sample sizes are not explicitly stated for all tests but are implied by the results provided (e.g., ranges for width/thickness indicate multiple measurements). These tests are typically performed on a statistically relevant sample size according to the respective ASTM standards.
    • Biocompatibility (ISO 10993 series): Sample sizes for the animal studies (toxicity, irritation, sensitization) are not detailed in this summary but would have followed the guidance of the ISO standards.
    • Chemotherapy Permeation (ASTM D6978): The permeation results are presented as single breakthrough times for each drug, implying a specific test protocol dictated by the standard, likely involving multiple replicates to ensure reproducibility, though the exact number isn't given.
  • Data Provenance: The data is derived from benchtop performance testing and biocompatibility testing. The manufacturer is based in Guangdong, China, which implies the testing was conducted there or by affiliated labs. The document does not specify if the data is retrospective or prospective; however, given it's a 510(k) submission, it's typically data collected specifically for the regulatory submission (i.e., prospective for this purpose).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This submission is for a Class I medical examination glove, which relies on standardized bench testing rather than interpretation of complex medical images or clinical outcomes that would require expert consensus (e.g., radiologists). Therefore, there were no human experts establishing "ground truth" in the diagnostic sense. The "ground truth" for the performance characteristics (e.g., tensile strength, breakthrough time) is defined by the validated test methods and their quantitative results.

4. Adjudication Method for the Test Set

Not applicable. As described above, this involves quantitative bench testing and not subjective expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This device is a physical glove, and its performance is evaluated through laboratory bench tests.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable to this device. This is a physical non-diagnostic medical device. There is no algorithm or AI component involved, hence no "standalone" algorithm performance to evaluate. The device's performance is inherently "standalone" in that it performs its function (e.g., barrier to chemicals, physical strength) intrinsically.

7. The Type of Ground Truth Used

The ground truth used for this device's performance testing is based on:

  • Standardized Test Methods (Benchtop Data): Adherence to specific ASTM and ISO standards (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ASTM D6978, ISO 10993-10, ISO 10993-11). The results obtained from these tests are considered the objective ground truth for the glove's physical and chemical resistance properties.
  • Chemical Permeation Data: Direct quantitative measurement of breakthrough times for specific chemotherapy drugs, as determined by ASTM D6978-05.
  • Biocompatibility Data: Results from in vivo (for toxicity, irritation, sensitization) studies following ISO 10993 guidelines, which define the biological response to the material.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

§ 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.