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A Powder Free Examination Glove is a disposable device intended for Medical Purpose that is worn on the examiner's hand of fingers to prevent contamination between patient and examiner and for use with Chemotherapy Drugs In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by Chemotherapy drugs

The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, powder free, with tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue colour, powder free and non sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.

This document describes the validation of the "EMG Blue Nitrile Examination Gloves Powder Free with Tested for Use with Chemotherapy Drugs" (K141623) by establishing its substantial equivalence to a legally marketed predicate device (K110921). The "device" in this context refers to these medical examination gloves.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparative table between the subject device (K141623) and the predicate device (K110921), outlining acceptance criteria for various characteristics and how both devices perform against them.

2. Cyclophosphamide (20mg/ml): > 240 minutes
3. Cytarabine (100mg/ml): > 240 minutes
4. Doxorubicin Hydrochloride (2 mg/ml): > 240 minutes
5. Etoposide (20mg/ml): > 240 minutes
6. Fluorouracil (50mg/ml): > 240 minutes
7. Methorexate (25mg/ml): > 240 minutes
8. Paclitaxel (6mg/ml): > 240 minutes
9. Thiotepa (10mg/ml): 67.8 minutes | 1) Carmustine (3.3mg/ml): 4.5min.
10. Cyclophosphamide (20mg/ml): >240 min.
11. Cytarabine (100mg/ml): >240 min.
    4)Doxorubicin Hydrochloride (2.0mg/ml): >240 min.
12. Etoposide (20mg/ml): >240 min.
13. Flourouracil (50mg/ml): >240 min.
14. Methorexate (25mg/ml): > 240 min.
15. Paclitaxel (6mg/ml): >240 min.
16. Thiotepa (10mg/ml): 6.88 min. |

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a substantial equivalence demonstration based on performance testing and comparison to a predicate device.

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

• Sample Size for Test Set: The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for pinholes, or how many individual glove samples were used for chemotherapy permeation per drug). However, the general acceptance criteria for "Freedom from pinholes" adheres to AQL 2.5, Inspection Level G-1, which implies a sampling plan defined by ASTM D5151-06. The dimensions, physical properties, and residual powder also refer to ASTM standards (D6319-10 and D6124-06) which include sampling plans. For the chemotherapy drug permeation, it states "Minimum Breakthrough detection time" for each drug, which is typically derived from a set of tests.
• Data Provenance: The manufacturing company is ECO MEDI GLOVE SDN. BHD. from Malaysia. Therefore, the testing and data provenance is likely from Malaysia or conducted by a laboratory collaborating with the Malaysian manufacturer. The document doesn't specify if the data is retrospective or prospective, but given it's part of a 510(k) submission, it would be collected specifically for the purpose of demonstrating equivalence, making it effectively prospective for this regulatory submission.

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

This type of device (medical examination gloves) does not typically involve human experts establishing "ground truth" in the way a diagnostic AI device would. The "ground truth" here is objective measurement against established industry standards and regulatory requirements.

• For standards like ASTM D6319-10 (physical properties), ASTM D5151-06 (pinholes), ASTM D6124-06 (residual powder), and ASTM D6978-05 (chemotherapy permeation), the "ground truth" is defined by the methodology and specifications within the standard itself, executed by trained laboratory personnel.
• For biological evaluations (skin irritation, dermal sensitization), "ground truth" is established through standardized biological testing protocols and interpreted by qualified toxicologists or biologists, although the specific number and qualifications are not detailed here.

4. Adjudication Method for the Test Set:

Not applicable in the conventional sense for this type of device. The determination of whether a glove "meets" a standard (e.g., AQL 2.5 for pinholes) is based on the objective outcome of the standardized test and the defined acceptance limits, not human expert adjudication of a diagnostic result.

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

Not applicable. This is not an AI diagnostic device where human reader performance (with or without AI assistance) would be a relevant metric. The device is a physical product (gloves) whose performance is measured against physical and chemical standards.

6. Standalone Performance Study (Algorithm Only):

Not applicable. This is not an algorithm or software device. The "performance" described is that of the physical glove itself.

7. Type of Ground Truth Used:

The ground truth used is primarily based on established industry standards and physical/chemical measurements:

• Physical Specifications: Dimensions, tensile strength, ultimate elongation, freedom from pinholes (AQL 2.5, Inspection Level G-1), residual powder. These are objective measurements compared against criteria set in ASTM standards (D6319-10, D5151-06, D6124-06).
• Biocompatibility: Primary Skin Irritation Test and Dermal Sensitization Assay results (non-irritant, non-sensitizer). These are derived from biological testing protocols following standard toxicology guidelines.
• Chemical Resistance: Minimum Breakthrough Detection Time for various chemotherapy drugs, measured according to ASTM D6978-05. This involves laboratory testing where the time it takes for a chemical to permeate the glove material is objectively measured.

8. Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a 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.

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