(92 days)
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) - Extended Cuff, is a sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) and Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff, are disposable, single-use, sterile, blue-colored, and powder-free examination gloves made from nitrile latex.
The provided FDA 510(k) clearance letter pertains to medical examination gloves, not an AI-powered medical device. Therefore, the document does not contain information about the acceptance criteria and study proving an AI device meets those criteria.
The information typically found in such a submission would include:
- Device performance: This document explicitly states the "Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)" has been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
- Acceptance Criteria/Performance Data: The acceptance criteria for the gloves are based on relevant ASTM standards for physical properties, barrier integrity, and biocompatibility. The chemotherapy drug resistance is presented as "Minimum Breakthrough Detection Time in Minutes."
- Study Design (Non-Clinical): The studies are non-clinical, primarily laboratory-based physical and chemical tests compliant with recognized international and national standards (e.g., ASTM, ISO).
- Ground Truth: For these types of devices, the "ground truth" is typically defined by quantifiable physical and chemical properties measured against established standard methods (e.g., measuring milligrams of residual powder, breakthrough time of chemicals). There are no human experts, adjudication, or training/test sets in the context of AI for this type of device.
Given this, I cannot extract the information required for an AI-powered device from this document. The sections you asked for (sample size for test/training, expert qualifications, MRMC studies, standalone performance, etc.) are specific to AI/software as a medical device (SaMD) assessments and are not present in a submission for examination gloves.
However, I can summarize the acceptance criteria and reported performance for the examination gloves as provided in the document:
Acceptance Criteria and Reported Device Performance (for Examination Gloves)
This table summarizes the non-clinical acceptance criteria and the "result" or reported performance for the Sterile Nitrile Powder Free Examination Gloves.
| Test / Characteristic | Acceptance Criteria / Standard Reference | Reported Device Performance |
|---|---|---|
| Freedom from holes | Meets ASTM D5151-19 (R2023): AQL 1.5% | Pass |
| Residual Powder | Meets ASTM D6124-06 (R2022): Average less than 2 mg/glove | Pass |
| Dimensions (Length) | Meets ASTM D6319-19 (R2023): Overall Length: ≥ 230 mm (Subject Device 1); ≥ 260 mm (Subject Device 2) | Pass (Conforms to ASTM D6319 width, thickness, and length requirements) |
| Dimensions (Width) | Meets ASTM D6319-19 (R2023): Specific ranges for XS, S, M, L, XL | Pass (Conforms to ASTM D6319 width, thickness, and length requirements) |
| Dimensions (Thickness) | Meets ASTM D6319-19 (R2023): Palm Thickness: ≥ 0.05 mm; Finger Thickness: ≥ 0.05 mm | Pass (Conforms to ASTM D6319 width, thickness, and length requirements) |
| Tensile Strength Before Aging | Meets ASTM D6319-19 (R2023): ≥ 14 MPa | Pass (Conforms) |
| Tensile Strength After Aging | Meets ASTM D6319-19 (R2023): ≥ 14 MPa | Pass (Conforms) |
| Ultimate Elongation Before Aging | Meets ASTM D6319-19 (R2023): ≥ 500 % | Pass (Conforms) |
| Ultimate Elongation After Aging | Meets ASTM D6319-19 (R2023): ≥ 400 % | Pass (Conforms) |
| Primary Skin Irritation | ISO 10993-23: Not an irritant | Under the conditions of the study, not an irritant. |
| Dermal Sensitization | ISO 10993-10: Not a sensitizer | Under the conditions of the study, not a sensitizer. |
| Acute Systemic Toxicity | ISO 10993-11: No evidence of acute systemic toxicity | Under the conditions of this study, no acute systemic toxicity. |
| Chemotherapy Drug Permeation | ASTM D6978 (No specific 'Pass/Fail' criterion listed, rather minimum breakthrough times are reported.) | Listed in table below. |
| Fentanyl Citrate Permeation | ASTM D6978 (No specific 'Pass/Fail' criterion listed, rather minimum breakthrough times are reported.) | > 240 minutes |
Chemotherapy Drug and Fentanyl Citrate Permeation Results
Device Performance (Minimum Breakthrough Detection Time in Minutes)
| Chemotherapy Drug and Concentration | Subject Device Result |
|---|---|
| Carmustine (3.3 mg/ml) | 38.3 |
| Cisplatin (1.0 mg/ml) | > 240 |
| Cyclophosphamide (20.0 mg/ml) | > 240 |
| Dacarbazine (10.0 mg/ml) | > 240 |
| Doxorubicin HCl (2.0 mg/ml) | > 240 |
| Etoposide (20.0 mg/ml) | > 240 |
| Fluorouracil (50.0 mg/ml) | > 240 |
| Methotrexate (25.0 mg/ml) | > 240 |
| Mitomycin C (0.5 mg/ml) | > 240 |
| Paclitaxel (6.0 mg/ml) | > 240 |
| Thiotepa (10.0 mg/ml) | 78.6 |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
| Vidaza (5-Azacytidine), 25 mg/ml | > 240 |
| Busulfan, 6 mg/ml | > 240 |
| Carboplatin, 10 mg/ml | > 240 |
| Docetaxel, 10 mg/ml | > 240 |
| Epirubicin HCl, 2 mg/ml | > 240 |
| Gemcitabine HCl, 38 mg/ml | > 240 |
| Ifosfamide, 50 mg/ml | > 240 |
| Irinotecan, 20 mg/ml | > 240 |
| Mitoxantrone HCl, 2 mg/ml | > 240 |
| Oxaliplatin, 5 mg/ml | > 240 |
| Vinorelbine, 10 mg/ml | > 240 |
| Fentanyl Citrate Injection (100mcg/2ml) | > 240 |
Since the provided document is not for an AI device, the following points cannot be addressed:
- Sample sized used for the test set and the data provenance: Not applicable to a physical glove.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for gloves is based on physical/chemical measurements by laboratory technicians following standard protocols.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For gloves, it's objective physical/chemical measurements according to ASTM/ISO standards.
- The sample size for the training set: Not applicable (no AI training involved).
- How the ground truth for the training set was established: 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.