(84 days)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves were tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric acid and Xylazine in Fentanyl Citrate in accordance with ASTM D6978-05 Standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate is a Class I patient examination glove and specialty chemotherapy gloves, that made from synthetic nitrile latex. They are pink color, non-sterile, powder-free, fingertip textured, ambidextrous with beaded cuff, and single use only, and come in different sizes- XS, S, M, L, XL and XXL.
The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been been tested for biocompatibility and permeability to chemotherapy drugs, Fentanyl Citrate, Gastric Acid and Xylazine in Fentanyl Citrate.
This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device submitted for FDA 510(k) clearance.
The device in question is Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate.
Acceptance Criteria and Device Performance Study
The acceptance criteria for this device are primarily based on established industry standards for medical examination gloves and specific permeation resistance tests for various chemical substances. The study conducted to prove the device meets these criteria is a series of non-clinical performance tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Freedom From Holes | ASTM D6319-19, ASTM D5151-19 | Meet requirement inspection level G-1, AQL 2.5 (ISO2859-1) | Pass |
| Dimension - Length | ASTM D6319-19 | Minimum 220mm for size XS-S | |
| Minimum 230mm for size M-XXL | Pass | ||
| Dimension - Width | ASTM D6319-19 | XS: 70±10mm | |
| S: 80±10mm | |||
| M: 95±10mm | |||
| L: 110±10mm | |||
| XL: 120±10mm | |||
| XXL: 130±10mm | Pass | ||
| Dimension - Thickness | ASTM D6319-19 | Finger: 0.05mm (min) | |
| Palm: 0.05mm (min) | Pass | ||
| Physical Properties | ASTM D6319-19, ASTM D412-16 | Before aging: | |
| Tensile Strength (Min 14 Mpa) | |||
| Elongation (Min 500%) | |||
| After aging: | |||
| Tensile Strength (Min 14 Mpa) | |||
| Elongation (Min 400%) | Pass (All criteria met) | ||
| Powder Residue | ASTM D6319-19, ASTM D6124-06 | Not more than 2 mg per glove | Pass |
| Skin Irritation (Biocompatibility) | ISO10993-23:2021 | Under the conditions of the study, not a primary skin irritant | Pass (Not a primary skin irritant) |
| Skin Sensitization (Biocompatibility) | ISO10993-10:2021 | Under the conditions of the study, not a contact sensitizer | Pass (Not a contact sensitizer) |
| Acute Systemic Toxicity (Biocompatibility) | ISO 10993-11:2017 | Under the conditions of the study, no signs of acute systemic toxicity were observed | Pass (No signs of acute systemic toxicity were observed) |
| Chemotherapy Drugs Permeation | ASTM D6978-05 (2023) | Minimum Breakthrough Detection Time (minutes) | |
| Carboplatin: >240 | |||
| Carmustine: Varies (15.3 min reported) | |||
| Cisplatin: >240 | |||
| Cyclophosphamide: >240 | |||
| Cytarabine HCl: >240 | |||
| Dacarbazine: >240 | |||
| Daunorubicin HCl: >240 | |||
| Doxorubicin HCl: >240 | |||
| Etoposide: >240 | |||
| 5-Fluorouracil: >240 | |||
| Gemcitabine HCl: >240 | |||
| Ifosfamide: >240 | |||
| Irinotecan HCl: >240 | |||
| Mechlorethamine HCl: >240 | |||
| Melphalan HCl: >240 | |||
| Methotrexate: >240 | |||
| Mitomycin-C: >240 | |||
| Mitoxantrone HCl: >240 | |||
| Pacilitaxel: >240 | |||
| Thiotepa: Varies (28.2 min reported) | Carboplatin: >240 min. | ||
| Carmustine: 15.3 min. | |||
| Cisplatin: >240 min. | |||
| Cyclophosphamide: >240 min. | |||
| Cytarabine HCl: >240 min. | |||
| Dacarbazine: >240 min. | |||
| Daunorubicin HCl: >240 min. | |||
| Doxorubicin HCl: >240 min. | |||
| Etoposide: >240 min. | |||
| 5-Fluorouracil: >240 min. | |||
| Gemcitabine HCl: >240 min. | |||
| Ifosfamide: >240 min. | |||
| Irinotecan HCl: >240 min. | |||
| Mechlorethamine HCl: >240 min. | |||
| Melphalan HCl: >240 min. | |||
| Methotrexate: >240 min. | |||
| Mitomycin-C: >240 min. | |||
| Mitoxantrone HCl: >240 min. | |||
| Pacilitaxel: >240 min. | |||
| Thiotepa: 28.2 min. | |||
| Note: The document explicitly states that Carmustine and Thiotepa have "extremely low permeation times" and are accompanied by a "Warning: Do not use with Carmustine and Thiotepa," indicating that the stated permeation times for these two drugs are not >240 minutes and are accepted for the specified usage. | |||
| Fentanyl, Gastric Acid, Xylazine Permeation | ASTM D6978-05 (2023) | Minimum Breakthrough Detection Time (minutes) | |
| Fentanyl Citrate Injection: >240 | |||
| Simulated Gastric Acid: >240 | |||
| Fentanyl Citrate:Xylazine HCl (50:50): >240 | Fentanyl Citrate Injection: >240 min. | ||
| Simulated Gastric Acid: >240 min. | |||
| Fentanyl Citrate (50mcg/ml): Xylazine HCl (100mg/ml), 50:50: >240 min. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes (number of gloves) used for each individual test. However, it indicates that the tests were conducted according to established ASTM and ISO standards, which typically specify appropriate sample sizes for such tests to ensure statistical validity.
The data provenance is through non-clinical testing performed in accordance with recognized international and national standards (ASTM, ISO). This implies the data were prospectively generated for the purpose of this submission. The country of origin of the data is not specified, but the use of international standards suggests a globally accepted testing methodology.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable (N/A) as the device is a physical product (medical glove) and the performance is evaluated through objective, standardized laboratory tests (e.g., measuring permeation time, tensile strength, dimensions) rather than expert interpretation of images or clinical data. There is no "ground truth" established by human experts in the context of diagnostic accuracy for this type of device.
4. Adjudication Method for the Test Set
This information is not applicable (N/A) for the same reason as above. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation (e.g., radiology reads) where discrepancies need to be resolved. The tests performed for this device are objective measurements.
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
This information is not applicable (N/A). This document pertains to the clearance of a physical medical device (gloves), not an AI algorithm or a diagnostic imaging device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable (N/A). As mentioned, this is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective, quantitative measurements obtained through standardized laboratory testing methodologies (ASTM and ISO standards). For example:
- Permeation: Measured breakthrough time of specific chemicals through the glove material.
- Physical Properties: Measured tensile strength, elongation, length, width, and thickness.
- Biocompatibility: Observed biological responses (e.g., irritation, sensitization, systemic toxicity) in controlled in-vitro or in-vivo (animal) tests as per ISO standards.
This is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on direct physical and chemical testing.
8. The Sample Size for the Training Set
This information is not applicable (N/A). This device is a manufactured product that undergoes performance and biocompatibility testing. There is no "training set" in the context of machine learning. The manufacturing process is designed and validated to consistently produce gloves meeting the specified criteria.
9. How the Ground Truth for the Training Set was Established
This information is not applicable (N/A) as there is no training set for this device. The "ground truth" for the device's design and manufacturing is derived from the established standards (ASTM, ISO) that define the performance characteristics expected of such gloves. Quality control during manufacturing ensures conformity to these 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.