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510(k) Data Aggregation
(244 days)
A powder-free 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. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drugs have extremely low permeation times: 45.4 minutes and Thiotepa: 23.5 minutes. Warning: Do not use with Carmustine or Thiotepa.
Microflex 73-743 Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs is a non-sterile, single use only, disposable, powder free examination gloves. Characteristics: - . Ambidextrous with beaded cuff and straight fingers - Finger-textured . - . Blue colored - Five (5) sizes – extra-small, small, medium, large, and extra-large - . Tested against chemotherapy drugs High levels of ozone will degrade rubber material of the glove; therefore, the glove should be protected from ozone in particular. The glove is designed to meet the specifications of ASTM D6977-19, Standard Specification for Polychloroprene Examination Gloves for Medical Application.
This document is a 510(k) premarket notification for a medical device: "Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs".
The information provided describes the product's acceptance criteria and the non-clinical testing performed to demonstrate that the device meets some of these criteria. However, it does not describe an AI/ML-driven medical device, nor does it detail a study proving that an AI/ML device meets acceptance criteria. Therefore, I am unable to answer the questions related to AI/ML device performance, ground truth, expert opinions, or MRMC studies.
Instead, I will extract the acceptance criteria and study information related to the glove's performance as described in the document.
Acceptance Criteria and Study for the Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
This submission is for a physical medical device (examination glove), not an AI/ML system. Therefore, the "acceptance criteria" relate to the physical and chemical performance characteristics of the glove. The "study" refers to non-clinical laboratory testing.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is assessed against recognized standards, primarily ASTM D6977-19, ASTM D5151, ASTM D6124, and ASTM D6978-05 for chemotherapy drug permeation, as well as ISO 10993 series for biocompatibility.
| Test Methodology / Characteristic | Acceptance Criteria (Standard) | Reported Device Performance (Results) |
|---|---|---|
| Physical Characteristics: | ||
| Dimensions (ASTM D6977-19): | Meets ASTM D6977-19 requirements for length, width and thickness | |
| - Length | Minimum 230mm | Minimum 240mm |
| - Palm Width (XS) | $70 \pm 10$ mm | $75 \pm 5$ mm |
| - Palm Width (S) | $80 \pm 10$ mm | $85 \pm 5$ mm |
| - Palm Width (M) | $95 \pm 10$ mm | $95 \pm 5$ mm |
| - Palm Width (L) | $110 \pm 10$ mm | $105 \pm 5$ mm |
| - Palm Width (XL) | $120 \pm 10$ mm | $115 \pm 5$ mm |
| - Thickness (Finger) | Minimum 0.05 mm | Finger - min 0.09 mm |
| - Thickness (Palm) | Minimum 0.05 mm | Palm - min 0.06 mm |
| - Thickness (Cuff) | - (Not specified in standard for comparison) | Cuff - min 0.05 mm |
| Physical Properties (ASTM D6977-19): | Meets ASTM D6977-19 requirements for tensile strength and ultimate elongation before and after accelerated aging. | Meets ASTM D6977-19 requirements for tensile strength and ultimate elongation before and after accelerated aging. |
| - Tensile Strength (Before Aging) | Minimum 14 MPa | Minimum 16 MPa |
| - Tensile Strength (After Aging) | Minimum 14 MPa | Minimum 14 MPa |
| - Ultimate Elongation (Before Aging) | Minimum 500% | Minimum 500% |
| - Ultimate Elongation (After Aging) | Minimum 400% | Minimum 400% |
| Freedom from Holes (ASTM D6977-19, ASTM D5151-06): | AQL 2.5 | Meets or exceeds ASTM D6977-19 and ASTM D5151-06 requirements of AQL 2.5 |
| Powder Residual (ASTM D6977-19, ASTM D6124-06): | Not more than 2.0 mg/glove | Meets applicable requirement for powder free; ≤ 2 mg per glove |
| Biocompatibility: | ||
| - ISO Skin Irritation Study | ISO10993-10:2010 (Not an irritant) | Under the conditions of the study, not an irritant |
| - ISO Maximization Sensitization Study | ISO 10993-10:2010 (Not a sensitizer) | Under the conditions of the study, not a sensitizer |
| - ISO Acute Systemic Toxicity | ISO 10993-11: 2006 (No evidence of systemic toxicity) | Under the conditions of the study, no evidence of systemic toxicity |
| - ISO In Vitro Cytotoxicity | ISO 10993-5:2009 (Non-cytotoxic at specified dilutions) | Under the conditions of the study, undiluted, 1:2, and 1:4 dilutions were cytotoxic (grade 4). Dilutions of 1:8 (grade 2), 1:16 (grade 1), 1:32 and 1:64 (grade 0) were non-cytotoxic. (This indicates cytotoxicity at high concentrations, which is a common finding for glove materials, and the acceptance is based on non-cytotoxicity at lower, clinically relevant dilutions for biocompatibility). |
| Chemotherapy Permeation (ASTM D6978-05): | Times as per standard/previous testing (predicate device, if applicable) | |
| - Carmustine - 3.3 mg/ml | - (Comparison to predicate: 47.9 minutes) | 45.4 minutes |
| - Cisplatin - 1.0 mg/ml | - (Not explicitly in predicate comparison table) | >240 minutes |
| - Cyclophosphamide - 20.0 mg/ml | >240 minutes | >240 minutes |
| - Dacarbazine - 10.0 mg/ml | - (Not explicitly in predicate comparison table) | >240 minutes |
| - Doxorubicin HCl - 2.0 mg/ml | >240 minutes | >240 minutes |
| - Etoposide - 20.0 mg/ml | >240 minutes | >240 minutes |
| - Fluorouracil - 50.0 mg/ml | >240 minutes | >240 minutes |
| - Methotrexate - 25.0 mg/ml | >240 minutes | >240 minutes |
| - Paclitaxel - 6.0 mg/ml | >240 minutes | >240 minutes |
| - Thiotepa - 10.0 mg/ml | >240 minutes (from predicate) | 23.5 minutes (Note: This is significantly lower than the predicate for the same drug, leading to a warning for its use with this glove.) |
| - Vincristine Sulfate - 1.0 mg/ml | >240 minutes | >240 minutes |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify exact sample sizes for each test beyond indicating the tests were conducted. However, standards like ASTM and ISO have prescribed sample sizes and methodologies. For instance, for chemotherapy drug permeation testing as per ASTM D6978-05, a minimum of three specimens are tested per drug (indicated by "Average Minimum Breakthrough Detection Time (Sample 1,2,3)").
The data provenance is not explicitly stated as retrospective or prospective or by country of origin, but it originates from non-clinical laboratory testing performed to meet recognized international standards. This type of testing is typically prospective, conducted under controlled laboratory conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable as this is a non-clinical device that relies on standardized laboratory testing rather than human expert interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. The testing is based on objective measurements and adherence to specified standard protocols, not expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for the performance claims of this medical glove consists of measurements obtained according to established and recognized international laboratory standards (e.g., ASTM, ISO). For example:
- Physical dimensions and properties are measured directly.
- Freedom from holes is determined by a water leak test.
- Powder residual is measured gravimetrically.
- Biocompatibility is assessed through in vitro and in vivo biological tests with specific endpoints (e.g., cell viability for cytotoxicity, skin reactions for irritation/sensitization).
- Chemotherapy drug permeation is measured using highly sensitive analytical methods to detect breakthrough time.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device; there is no "training set."
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