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510(k) Data Aggregation
(27 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves are a patient examination glove that is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs. The purpose of this submission is to add two additional sizes (AMERI-TUFF Series 4000 XS and XXL) and additional series (AMERI-TOUCH Series 5000 XS through XXL) of SafeSource Direct Blue Powder-Free Nitrile Exam Glove
This document is a 510(k) Summary for a medical device (SafeSource Direct Blue Powder-Free Nitrile Exam Gloves) seeking FDA clearance. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data (i.e., laboratory testing). It does not involve a study of an AI-powered device or a human-in-the-loop performance study.
Therefore, many of the requested elements related to AI/MRMC studies, expert ground truth adjudication, and training/test set details for AI models are not applicable to this document. I will focus on the acceptance criteria and the study that proves the device meets those criteria, as detailed in the provided text.
Here's a breakdown based on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The device under review includes two series of gloves: AMERI-TUFF Series 4000 and AMERI-TOUCH Series 5000. Not all tests explicitly differentiate between the series in the summary table, but chemotherapy permeation times are distinct.
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm):XS/S: ≥ 220M/L/XL/XXL: ≥ 230Width (mm):XS: 70 ± 10S: 80 ± 10M: 95 ± 10L: 110 ± 10XL: 120 ± 10XXL: 130 ± 10Thickness (mm):Finger: ≥ 0.05Palm: ≥ 0.05 | Length (mm):XS/S: ≥ 220 / PassM/L/XL/XXL: ≥ 230 / PassWidth (mm):XS: 70 ± 10 / PassS: 80 ± 10 / PassM: 95 ± 10 / PassL: 110 ± 10 / PassXL: 120 ± 10 / PassXXL: 130 ± 10 / PassThickness (mm):Finger: 0.05 / PassPalm: 0.05 / Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | Complies with ASTM D6319-19 and ASTM D5151-06 (Though the table specifically lists "Complies with ASTM D6319-19 and ASTM D5151-06", the stated acceptance criteria for D5151 is AQL 2.5, implying the result also meets this). |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0 mg | 0.08-0.44 mg / Pass |
| ASTM D412 | Physical Properties (Tensile Strength & Elongation) | Before Aging:Tensile Strength ≥ 14 MPaUltimate Elongation ≥ 500%After Aging:Tensile Strength ≥ 14 MPaUltimate Elongation ≥ 400%Meet the requirements of ASTM D412 AQL 4.0 (for both before and after aging) | Before Aging:Tensile Strength: 14 – 19 MPaUltimate Elongation: 515 - 540% / PassAfter Aging:Tensile Strength: (Implied to be ≥ 14 MPa, results not explicitly stated but "Pass")Ultimate Elongation: (Implied to be ≥ 400%, results not explicitly stated but "Pass")Pass (for AQL 4.0) |
| ISO 10993-11 | Acute Systemic Toxicity | Non-Acute Systemic Toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo. / Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under conditions of the study, not an irritant. / Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. / Pass |
| ASTM D6978-05 (Reapproved 2019) | Permeation by Chemotherapy Drugs | Specified minimum breakthrough detection times for various chemotherapy drugs (values vary by drug). Note: Carmustine and Thio-Tepa have "low permeation times" and are "Not recommended for use with these drugs." (Acceptance is implicitly meeting the tested values or demonstrating non-inferiority to predicate for those above threshold.) | AMERI-TUFF Series 4000:Carmustine (BCNU) 3.3 mg/ml: 35.8 MinutesCisplatin 1.0 mg/ml: ≥ 240 MinutesCyclophosphamide (Cytoxan) 20.0 mg/ml: ≥ 240 MinutesDacarbazine (DTIC) 10.0 mg/ml: ≥ 240 MinutesDoxorubicin Hydrochloride 2.0 mg/ml: ≥ 240 MinutesEtoposide (Toposar) 20.0 mg/ml: ≥ 240 MinutesFluorouracil 50.0 mg/ml: ≥ 240 MinutesMethotrexate 25 mg/ml: ≥ 240 MinutesMitomycin C 0.5 mg/ml: ≥ 240 MinutesPaclitaxel (Taxol) 6.0 mg/ml: ≥ 240 MinutesThio-Tepa 10.0 mg/ml: 87.0 MinutesVincristine Sulfate (Oncovin) 1.0 mg/ml: ≥ 240 MinutesAMERI-TOUCH Series 5000:Carmustine (BCNU) 3.3 mg/ml: 22.5 MinutesCisplatin 1.0 mg/ml: ≥ 240 MinutesCyclophosphamide (Cytoxan) 20.0 mg/ml: ≥ 240 MinutesDacarbazine (DTIC) 10.0 mg/ml: ≥ 240 MinutesDoxorubicin Hydrochloride 2.0 mg/ml: ≥ 240 MinutesEtoposide (Toposar) 20.0 mg/ml: ≥ 240 MinutesFluorouracil 50.0 mg/ml: ≥ 240 MinutesMethotrexate 25 mg/ml: ≥ 240 MinutesMitomycin C 0.5 mg/ml: ≥ 240 MinutesPaclitaxel (Taxol) 6.0 mg/ml: ≥ 240 MinutesThio-Tepa 10.0 mg/ml: 37.5 MinutesVincristine Sulfate (Oncovin) 1.0 mg/ml: ≥ 240 Minutes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test (e.g., number of gloves tested for physical dimensions, watertightness, or chemotherapy permeation). However, it indicates compliance with recognized standards such as ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, and ASTM D6978-05, and ISO 10993 series. These standards typically specify the required sample sizes for testing.
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective/prospective. Given this is a 510(k) submission for a medical device (gloves), the testing would be prospective laboratory testing conducted to demonstrate compliance with performance standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The "ground truth" for glove performance tests outlined here is based on objective laboratory measurements against established ASTM and ISO standards, not on expert interpretations or consensus of medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods are typically employed in studies involving human interpretation (e.g., radiologists reading medical images) to resolve discrepancies. The tests described are objective, physical, and chemical property measurements.
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 relevant for AI-powered devices where human readers are involved in diagnosis or intervention. This submission pertains to physical and chemical properties of examination gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, this is not an AI algorithm. The performance evaluation is based on standard laboratory testing of the physical and chemical properties of the gloves.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims of these gloves is based on:
- Compliance with established industry standards: ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards provide specific methodologies and acceptance criteria for physical properties (dimensions, tensile strength, elongation), watertightness, powder content, and biocompatibility.
- Laboratory measurements: Objective measurements of the gloves' properties (e.g., length, width, thickness, force required to break, elongation percentage, breakthrough time for chemotherapy drugs) against predefined thresholds within the standards.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI model requiring a training set. The device is a physical product (gloves) whose performance is established through manufacturing processes and validated through standardized testing.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no AI training set.
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