K Number
K123819
Device Name
MULTIPLE NAME
Date Cleared
2013-03-05

(83 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 glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.

Device Description

Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010). The gloves are non-sterile, ambidextrous and single-use disposable devices that come in five sizes (XS, S, M, L, XL).

AI/ML Overview

This document describes the acceptance criteria and performance of the "Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim".

1. Table of Acceptance Criteria and Reported Device Performance

CharacteristicAcceptance Criteria (Standards Requirements)Reported Device Performance (Results Summary)
DimensionsASTM D 3578-05 (2010): Length ≥ 270mm, Palm Thickness ≥ 0.20mm, Finger Thickness ≥ 0.25mm, Width (X-Small 70-80mm, Small 80-90mm, Medium 90-100mm, Large 101-111mm, X-Large ≥ 111mm)Meets Standard Requirements (Specific values provided in the submission align with or exceed criteria.)
Physical Properties (Tensile Strength, Elongation)ASTM D 3578-05 (2010): Before Aging: Tensile Strength ≥ 18 MPA, Elongation ≥ 650%; After Aging: Tensile Strength ≥ 14 MPA, Elongation ≥ 500%Meets Standard Requirements (Specific results provided in the submission align with or exceed criteria.)
Freedom from PinholesASTM D 5151-11, ASTM D 3578-05 (2010): Pass quality level at G1 AQL 1.5Meets Standard Requirements (Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5.)
Powder Free ResidueASTM D 6124-11, ASTM D 3578-05 (2010): ≤ 2 mg of residual powder per gloveMeets Standard Requirements (Result generated values ≤ 2 mg of residual powder per glove.)
Protein ContentASTM D 5712-10, ASTM D 3578-05 (2010): ≤ 50 microgram/dm²Meets Standard Requirements (Result generated values ≤ 50 microgram/dm².)
BiocompatibilityDermal Sensitization (as ISO 10993-10:2010), Primary Skin Irritation Test (as ISO 10993-10:2010)Meets Standard Requirements (Not a contact skin sensitizer, Not a primary skin irritant.)
Chemotherapy Drugs Permeation Test MethodASTM D6978-05Meets Standard Requirements (Tested for Use with Chemotherapy Drugs. Specific breakthrough times are listed for 15 drugs, with Carmustine and Thiotepa noted as having extremely short permeation times of 15.4 and 30.6 minutes, respectively.)

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

The document does not specify a distinct "test set" in the context of image or algorithmic data. Instead, it details various laboratory tests performed on the physical glove product. The sample sizes for each specific test (e.g., dimensions, physical properties, pinholes, protein content, biocompatibility, chemotherapy permeation) are not explicitly stated in the provided summary. However, it is implied that testing was conducted in accordance with the relevant ASTM and ISO standards, which typically prescribe minimum sample sizes for statistical validity.

Data Provenance: The data provenance is from laboratory testing performed by Top Calibre Sdn Bhd (Malaysia) or a contracted lab under their supervision, to demonstrate compliance with international standards (ASTM, ISO). This is retrospective data collected as part of the device's development and regulatory submission process.

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

N/A. This device is a physical product (medical glove), and the evaluation is based on laboratory performance against defined physical and chemical standards, not on expert interpretation of observational data or images. Therefore, clinical ground truth established by experts is not applicable.

4. Adjudication Method for the Test Set

N/A. As the evaluation is based on objective laboratory measurements against predefined standards, there is no need for an adjudication method as would be used in a clinical study with subjective interpretations.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

N/A. This is a physical product (glove) and not an AI or imaging device, so MRMC studies are not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

N/A. This is a physical product and does not involve an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established by:

  • International Standards: Primarily ASTM (American Society for Testing and Materials) standards (D3578-05, D5151-11, D6124-11, D5712-10, D6978-05) and ISO (International Organization for Standardization) standards (10993-10:2010) for physical, chemical, and biocompatibility properties. These standards define the acceptable range or threshold for each characteristic.
  • Direct Measurement/Testing: Laboratory measurements and assays were conducted to determine the actual performance values of the gloves (e.g., tensile strength, breakthrough time for chemotherapy drugs). These measurements are then compared directly to the specified acceptance criteria within the standards.

8. Sample Size for the Training Set

N/A. This is a physical product and does not involve AI or machine learning algorithms that would require a training set.

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

N/A. As there is no training set for an algorithm, this question is not applicable.

§ 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.