(88 days)
Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.
The subject device in 510(K) notification is a blue nitrile examination gloves powder free tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I). The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)
The provided document is a 510(k) Premarket Notification for "Blue Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs." This document clears a medical device (examination gloves) for market and is not an AI/ML device study. Therefore, most of the requested information about acceptance criteria and study design for AI/ML performance is not applicable within this context.
However, I can extract information related to the performance of these physical medical gloves as detailed in the provided document, specifically related to their physical properties and chemical resistance.
Here's the relevant information based on the document:
Study Purpose: To demonstrate that the "Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy Drugs" are as safe, effective, and perform as well as the legally marketed predicate device (Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for use with Chemotherapy Drugs) K210944).
Lack of AI/ML Study: This document does not describe a study involving an AI/ML device. It pertains to a physical medical device (examination gloves). Therefore, specific criteria and study details related to AI/ML device performance (such as sample size for test/training sets for AI, data provenance for AI, number of experts for AI ground truth, human reader improvement with AI assistance, standalone AI performance) are not present in this document and cannot be provided.
Acceptance Criteria and Device Performance (for Physical Device - Gloves):
The performance of the gloves was evaluated against ASTM standards for various physical properties and for resistance to chemotherapy drugs. The acceptance criteria and reported device performance are presented in the tables below.
Table 1: Physical Properties Acceptance Criteria and Device Performance
| Test Method (Standard) | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-2019 | To determine the length of the gloves | Min 220 mm for Size Small & Min 230 mm for all other sizes | Small: 245 mm; Medium: 246 mm; Large: 248 mm; X-Large: 248 mm |
| ASTM D6319-2019 | To determine the width of the gloves | Small: 80+/-10 mm; Medium: 95+/-10 mm; Large: 110+/-10 mm; X-Large: 120+/-10 mm | Small: 80 mm; Medium: 92 mm; Large: 105 mm; X-Large: 115 mm |
| ASTM D6319-2019 | To determine the thickness of the gloves | Palm 0.05 mm min; Finger 0.05 mm min for all sizes | Palm: 0.09 mm (all sizes); Finger: 0.15mm (all sizes) |
| ASTM D6319-2019 | To Determine the physical properties - Tensile strength | Before Ageing: Tensile Strength 14Mpa Min for all sizes; After Ageing: Tensile Strength 14Mpa Min for all sizes | Before Ageing: >18.52 Mpa (all sizes); After Ageing: >17.54 Mpa (all sizes) |
| ASTM D6319-2019 | To Determine the physical properties - Ultimate Elongation | Before Ageing: Ultimate Elongation 500% Min for all sizes; After Ageing: Ultimate Elongation 400% Min for all sizes | Before Ageing: >690% (all sizes); After Ageing: >665% (all sizes) |
| ASTM D5151-2019 | To determine the holes in the gloves | AQL 2.5 | Gloves Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved 2017) | To determine the residual powder in the gloves | 2 Mg/Glove Max | (Material Mediated Pyrogenicity) |
Table 3: Chemotherapy Drug Permeation Acceptance Criteria and Device Performance
(Note: The "acceptance criteria" here is implied by the predicate device's performance for comparison, and the requirement to report the minimum breakthrough detection time. A longer time generally indicates better performance.)
| Tested Chemotherapy Drug Name & Concentration | Predicate Device Minimum Breakthrough Detection Time | Proposed Device Minimum Breakthrough Detection Time |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | 14.5 Minutes | 34.3 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes | >240 Minutes |
| Thiotepa (10 mg/ml) | 47.4 Minutes | 87.3 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes | >240 Minutes |
| Drugs tested by Predicate but NOT Proposed: | Busulfan (6mg/ml) (>240 min), Cytarabine (100 mg/ ml) (>240 min), Docetaxel (10 mg/ml) (>240 min), Mechlorethamine HCL (1 mg/ml) (>240 min) | Not Tested |
| Note on warnings: | Warning: Do not use with Carmustine (BCNU) & Thiotepa |
2. Sample Size Used for the Test Set and Data Provenance:
- The document primarily refers to testing done in accordance with ASTM standards. These standards specify sample sizes for testing (e.g., for AQL testing for pinholes, or for physical properties). The exact number of samples for each specific test (e.g., how many gloves for tensile strength or how many for chemical permeation) is not explicitly stated in the summary, but it would be prescribed by the referenced ASTM standards (e.g., ASTM D6319-2019, ASTM D5151-2019, ASTM D6124-06, ASTM D6978-05).
- Data Provenance: The applicant for the device is Aspen Glove Sdn. Bhd., located in Malaysia. The testing would presumably have been conducted there or by a certified lab, but specific country of origin for the data (i.e., where the tests were physically performed) is not explicitly stated beyond the applicant's location. The testing would be prospective in nature as it evaluates the manufactured product.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- This is not applicable as this is a physical medical device and not an AI/ML device requiring establishment of "ground truth" by clinical experts for image interpretation or similar tasks. The "ground truth" for the physical properties and chemical resistance is established by validated laboratory testing methods conforming to recognized international standards (ASTM, ISO).
4. Adjudication Method for the Test Set:
- Not applicable. This is not a study requiring adjudication of expert interpretations but rather laboratory testing against established physical and chemical standards.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is a physical medical device, not an AI/ML device that assists human readers.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
- For physical and biocompatibility properties: Ground truth is established by validated laboratory testing methods against recognized industry standards (ASTM, ISO) with numerical or pass/fail criteria.
- For chemotherapy drug permeation: Ground truth is established by laboratory testing per ASTM D6978-05 (2019), measuring the minimum breakthrough detection time.
8. Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This is not an AI/ML 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.