(272 days)
The Nitrile Examination gloves,is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards : Practice for assessment of medical Glove to Permeation by Chemotherapy Drugs.
The subject device in this 510(k) Notification is Nitrile Examination Gloves Sterile with tested for use with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, white colour, powder free and sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-5, 10993-10, 10993-11 and permeability to chemotherapy drugs per ASTM D6978-05.
This document describes the acceptance criteria and performance of the Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White device (K190725) by Riverstone Resources SDN BHD.
1. Table of Acceptance Criteria and Reported Device Performance
The device was tested against several standards, and the results are summarized below. The "Acceptance Criteria" column refers to the specified requirements in relevant ASTM and ISO standards, while "Reported Device Performance" indicates whether the device met these criteria. "N/A" indicates that specific numerical acceptance criteria were not explicitly stated in the provided text for certain categories, but compliance with the standard itself serves as the acceptance.
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General | ||
| Product Code | LZA and LZC | LZA and LZC |
| Intended Use | A powder-free patient examination glove, disposable, for medical purposes, worn on examiner's hand or finger to prevent contamination between patient and examiner. For over-the-counter use. | A powder-free patient examination glove, disposable, for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner. For over-the-counter use. |
| Description | Sterile Examination glove made of Nitrile and color White. Tested with chemotherapy Drugs. | Sterile Examination glove made of Nitrile and color White and tested with chemotherapy Drugs. |
| Presentation | Sterile gloves provided in Pouches. | Sterile gloves are provided in Pouches. |
| Ambidextrous | Yes | Yes |
| Material Use | Nitrile Synthetic Latex | Nitrile Synthetic Latex |
| Colour | White | White |
| Sterility | ISO 11737-2:2009, EN ISO 11137-2:2015 | Sterility |
| Single Used | Single used | Single used |
| Non Sterile or Sterile | Sterile | Sterile |
| Dimensions (ASTM D6319-10) | Meets ASTM D6319-10 | |
| Overall Length (mm) | Min 230 mm | N/A (meets standard) |
| Width (± 5mm) | Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mm | N/A (meets standard) |
| Thickness at Palm (mm) | Min 0.05 mm | N/A (meets standard) |
| Thickness at Finger Tip (mm) | Min 0.05 mm | N/A (meets standard) |
| Physical Properties (ASTM D6319-10) | Meets ASTM D6319-10 | |
| Tensile Strength (MPa) - Before Ageing | ≥ 14 | N/A (meets standard) |
| Ultimate Elongation (%) - Before Ageing | ≥ 500 | N/A (meets standard) |
| Tensile Strength (MPa) - After Aging (70°C for 168 hrs / 100°C for 22 hrs) | ≥ 14 | N/A (meets standard) |
| Ultimate Elongation (%) - After Aging (70°C for 168 hrs / 100°C for 22 hrs) | ≥ 400 | N/A (meets standard) |
| Freedom from Pin-holes | AQL 2.5, Inspection Level G-1 (ASTM D6319-10) | Meets ASTM D5151-06 (Note: Table listed D6319-10 for Acceptance, but performance reported as D5151-06. Both are relevant for pinholes.) |
| Residual Powder (ASTM D6124-06) | 240 minutes |
- Cisplatin (1.0mg/ml): > 240 minutes
- Doxorubicin Hydrochloride (2.0mg/ml): > 240 minutes
- Etoposide (20mg/ml):> 240 minutes
- Fluorouracil (50mg/ml): > 240 minutes
- Methotrexate (25mg/ml): > 240 minutes
- Paclitaxel (6mg/ml): > 240 minutes
- Thiotepa (10mg/ml): 97.6 minutes
(Note: Breakthrough for Carmustine and Thiotepa listed on page 2 and 4 are the same.) |
Explanation of the Study and Device Performance:
The study conducted to prove the device meets the acceptance criteria is a series of non-clinical tests performed in accordance with recognized international and national standards. The results demonstrate that the subject device (Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White) meets all the specified performance requirements for patient examination gloves, including dimensions, physical properties, freedom from holes, residual powder, and biocompatibility.
Crucially, the gloves were specifically tested for use with chemotherapy drugs according to ASTM D6978-05: Practice for assessment of medical Glove to Permeation by Chemotherapy Drugs. The results show that for most tested chemotherapy drugs, the gloves provided a breakthrough detection time of greater than 240 minutes (4 hours), indicating good resistance. For Carmustine and Thiotepa, specific breakthrough times of 39 minutes and 97.6 minutes, respectively, were reported. These specific times serve as important cautions for users.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for dimensions, physical properties, or chemotherapy drug permeation). However, it references established standards such as ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05, as well as ISO 10993-10 and ISO 10993-11. These standards typically define appropriate sampling plans and methodologies for testing, implying that the sample sizes used conform to these guidelines.
The data provenance is from Malaysia, as Riverstone Resources SDN BHD is located in Malaysia (Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300, Bukit Beruntung Selangor, Malaysia). The studies were non-clinical, likely laboratory-based, and retrospective in the sense that the test results are reported from completed experiments to demonstrate compliance for premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The "ground truth" for this type of device (a medical glove) is established by adherence to recognized performance standards and laboratory test methods, rather than by expert consensus in a clinical diagnostic sense. The standards themselves (e.g., ASTM, ISO) represent a consensus of expert knowledge in materials science, manufacturing, and medical device testing. The personnel conducting the tests would be qualified laboratory technicians or engineers, but their specific number and qualifications are not detailed.
4. Adjudication Method for the Test Set:
An adjudication method (like 2+1 or 3+1) is typically used in clinical studies involving interpretation of medical images or patient outcomes, especially when there's subjective assessment involved. This document describes non-clinical, laboratory-based performance testing of a physical device against objective criteria defined by standards. Therefore, an adjudication method for determining "ground truth" as described (e.g., by multiple clinical experts) is not applicable to this type of study. The "ground truth" is the objective measurement against the specified standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted medical imaging devices where human readers interpret cases, and the AI's impact on their performance is being evaluated. This document is for a medical glove, which is a physical protective barrier, not a diagnostic tool requiring human interpretation of clinical cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No, a standalone (algorithm only) performance study was not done. This concept is applicable to AI or software medical devices. The device in question is a physical medical glove, and its performance is evaluated through laboratory tests, not an algorithm.
7. Type of Ground Truth Used:
The ground truth used for this device's evaluation is primarily based on established performance standards and objective laboratory measurements. This includes:
- Standard Specifications: Adherence to defined physical and chemical properties as outlined in standards like ASTM D6319-10 (dimensions, physical properties), ASTM D5151-06 (freedom from pinholes), ASTM D6124-06 (residual powder).
- Biocompatibility Test Results: Objective scientific assessment of biological responses in accordance with ISO 10993-10 (irritation, sensitization) and ISO 10993-11 (acute systemic toxicity).
- Permeation Resistance Measurements: Objective laboratory determination of breakthrough times for chemotherapy drugs using a standardized method (ASTM D6978-05).
8. Sample Size for the Training Set:
This information is not applicable. The device is a physical medical glove, not an artificial intelligence (AI) or machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this device.
§ 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.