(98 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 of Medical Gloves to Permeation by Chemotherapy Drugs.
Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Colored Tested for Use with Chemotherapy Drugs, Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Green Colored Tested for Use with Chemotherapy Drugs, Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Pink Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. A polyacrylic polymer is applied to the inner surface of the glove to make donning easy.
The provided text describes the acceptance criteria and the study that proves Ansell Healthcare Products LLC's Microflex® Nitrile Patient Examination Gloves (Blue, Green, and Pink colored) meet these criteria for use with chemotherapy drugs and, for the pink glove, Fentanyl Citrate.
Here's the breakdown as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the gloves are based on various ASTM standards and ISO standards for biocompatibility, in addition to performance against specific chemotherapy drugs. The reported device performance is directly compared against these standards and against a legally marketed predicate device (Micro-Touch NitraTex Sterile Nitrile Powder-Free Blue Examination Gloves, K082457).
Acceptance Criteria & Device Performance – Summary Table
| Characteristic | Standard/Acceptance Criteria | Reported Device Performance (Microflex® Nitrile Patient Examination Gloves) |
|---|---|---|
| Physical Properties: | ASTM D6319-10 (Nitrile Examination Gloves for Medical Application) | Meets ASTM D6319-10 requirements |
| Dimensions: | Length: Minimum 230mm; Palm width (XS-XL): 70±10 to 120±10 mm; Thickness (Finger, Palm): minimum 0.05 mm | Length: Minimum 240mm; Palm width (XS-XL): 75±5 to 115±5 mm; Thickness (Finger, Palm, Cuff): Finger - min 0.09mm, Palm - min 0.06mm, Cuff - min 0.05mm. |
| Tensile Strength: | Before Aging: minimum 14 MPa; After Aging: minimum 14 MPa | Before Aging: minimum 16 MPa; After Aging: minimum 14 MPa |
| Ultimate Elongation: | Before Aging: minimum 500%; After Aging: minimum 400% | Before Aging: minimum 500%; After Aging: minimum 400% |
| Freedom from holes: | ASTM D6319-10 & ASTM D5151-06 requirements of AQL 2.5 | Meets or exceeds ASTM D6319-10 and ASTM D5151-06 requirements of AQL 2.5 |
| Powder Residual: | ASTM D6319-10 & ASTM D6124-06: ≤ 2 mg per glove | Meets applicable requirement for powder free; ≤ 2 mg per glove |
| Biocompatibility: | ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Skin Irritation, Sensitization), ISO 10993-11: 2006 (Acute Systemic Toxicity) | Cytotoxicity: Under the conditions of the study, undiluted, 1:2, 1:4, 1:8, 1:16 dilution was cytotoxic. 1:32 and 1:64 are not cytotoxic. |
| Skin Irritation: Under the conditions of the study, not an irritant. | ||
| Sensitization: Under the conditions of the study, not a sensitizer. | ||
| Acute Systemic Toxicity: Under the conditions of the study, no evidence of systemic toxicity. | ||
| Chemotherapy Drug Permeation (ASTM D6978-05): | Predicate Device Permeation Times (for comparison) | Blue Gloves: |
| Carmustine (BCNU) - 3.3 mg/ml | Predicate: 32.1 min | Blue: 17.4 min; Green: 27.9 min; Pink: 23.4 min |
| Cyclophosphamide - 20.0 mg/ml | Predicate: >240 min | All: >240 min |
| Doxorubicin HCl - 2.0 mg/ml | Predicate: >240 min | All: >240 min |
| Etoposide - 20.0 mg/ml | Predicate: >240 min | All: >240 min |
| Fentanyl Citrate - 100 mcg/2mL | N/A (Tested for Pink only) | Pink: >240 min |
| Fluorouracil - 50.0 mg/ml | Predicate: >240 min | All: >240 min |
| Methotrexate - 25.0 mg/ml | Predicate: >240 min | All: >240 min |
| Paclitaxel - 6.0 mg/ml | Predicate: >240 min | All: >240 min |
| Thiotepa (THT) - 10.0 mg/ml | Predicate: 140.7 min | Blue: 67.1 min; Green: 48.6 min; Pink: 64.9 min |
| Vincristine Sulfate - 1.0 mg/ml | Predicate: >240 min | All: >240 min |
| Warning: Carmustine and Thiotepa have low permeation times. The warning "Do not use with Carmustine" is consistently included for all glove types. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample sizes (number of gloves or test replicates) used for each physical, chemical (chemotherapy permeation), and biocompatibility test. It only provides the summarized results (e.g., minimum values, average breakthrough times, or "meets requirements").
- Data Provenance: The data comes from the testing performed by the manufacturer, Ansell Healthcare Products LLC, for their 510(k) premarket notification. The document itself does not specify the country of origin where the testing was physically conducted. The data is retrospective in the sense that it was generated for the purpose of this submission, rather than a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This submission is for medical gloves and relies on laboratory-based performance testing against established ASTM and ISO standards, not human expert interpretation of medical images or patient data. Therefore, the concept of "ground truth" established by a panel of medical experts (like radiologists for imaging devices) is not applicable here. The "ground truth" is defined by the objective measurement protocols outlined in the referenced standards (e.g., ASTM D6319-10 for physical characteristics, ASTM D6978-05 for chemotherapy drug permeation, ISO 10993 series for biocompatibility). The testing would have been conducted by trained laboratory personnel in accordance with these validated methods.
4. Adjudication Method for the Test Set
- As the "ground truth" is based on objective laboratory measurements against defined standards, there is no adjudication method by multiple human reviewers in the context of medical image interpretation. The testing results are quantitative and directly compared to the numerical criteria specified in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. This device is a medical glove, not an AI-assisted diagnostic tool. Therefore, the concept of assessing human reader improvement with or without AI assistance is not relevant to this submission. The device's performance is measured by its physical properties, barrier protection, and biocompatibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
- No standalone algorithm performance study was done. This device is a physical product (a glove), not a software algorithm. Its performance is assessed through laboratory tests as described above.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- The "ground truth" for this device is based on objective, standardized laboratory test methods and their defined acceptance criteria. This includes:
- Physical Properties: Measurements (dimensions, tensile strength, elongation) compared against ASTM D6319-10.
- Barrier Integrity: Freedom from holes assessed against ASTM D6319-10 and ASTM D5151-06 (AQL 2.5).
- Chemical Permeation: Breakthrough detection times for chemotherapy drugs and Fentanyl Citrate determined per ASTM D6978-05.
- Biocompatibility: In vitro and in vivo testing for cytotoxicity, skin irritation, sensitization, and acute systemic toxicity evaluated against ISO 10993 series.
8. The Sample Size for the Training Set
- This submission describes a medical device (gloves), not an AI/ML algorithm. Therefore, the concept of a "training set" for model development is not applicable. The gloves were manufactured and then tested according to established quality control and regulatory requirements.
9. How the Ground Truth for the Training Set was Established
- As there is no training set for an AI/ML model, there is no ground truth established for a training set. The device's performance is demonstrated through direct testing against predefined physical, chemical, and biological standards.
§ 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.