(84 days)
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl test claim is a disposable device intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use.
In addition, these gloves were tested for use with Chemotherapy drugs and Fentanyl Test claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs and Fentanyl Test claim.
The subject device in this 510(k) Notification is EMG Blue Powder Free Nitrile Examination Gloves with Chemotherapy Drugs and Fentanyl Test Claim. The subject device is a patient examination glove made from nitrile latex compound, blue color, powder-free, and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, the Standard Specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs and fentanyl test claims.
The Blue Nitrile Medical Examination Gloves, Powder Free, is a disposable device intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner (product Code LZA) and are used with chemotherapy drugs (Product code LZC and OPJ) and fentanyl test (Product code QDO).
The provided document is an FDA 510(k) clearance letter for a medical device: Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim. This document describes the device's technical specifications and safety testing, not AI/ML algorithm development or performance in a clinical setting.
Therefore, the requested information often found in AI/ML performance studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, and ground truth establishment for training) is not applicable to this device and is not present in the provided text.
The document focuses on demonstrating substantial equivalence to a predicate device and confirming adherence to established physical, chemical, and biological safety standards for examination gloves.
Here's the information that is applicable and can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on various ASTM and ISO standards, primarily related to the physical properties, biocompatibility, and chemical resistance of examination gloves. The "Reported Device Performance" column reflects whether the device met these established standards.
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Product Code | (Not a quantitative criterion; refers to regulatory classification) | LZA, LZC, OPJ, and QDO |
| Intended Use | Prevent contamination between patient and examiner; tested for chemotherapy drugs and fentanyl. | Meets intended use. |
| Material Use | Nitrile compound | Nitrile compound |
| Color | Blue | Blue |
| Sterility | Non-sterile | Non-sterile |
| Surface | Finger Textured | Finger Textured |
| Cuffing Beading | Rolled Beading | Rolled Beading |
| Design | Ambidextrous | Ambidextrous |
| Overall Length (mm) | Min 230mm (ASTM D6319-19) | Meets ASTM D6319-19 (Min 230mm) |
| Width (± 10mm) | Size XXS = 65mm, XS = 75mm, S = 85mm, M = 95mm, L = 105mm, XL = 115mm, XXL=125mm, XXXL=135mm (ASTM D6319-19) | Meets ASTM D6319-19 (All listed sizes within ± 10mm) |
| Thickness at Palm (mm) | Min 0.05 mm (ASTM D6319-19) | Meets ASTM D6319-19 (Min 0.05 mm) |
| Thickness at Finger Tip (mm) | Min 0.05 mm (ASTM D6319-19) | Meets ASTM D6319-19 (Min 0.05 mm) |
| Tensile Strength (MPa) - Before Ageing | 14min (ASTM D6319-19, ASTM D412-16(2021)) | Meets ASTM D6319-19 (14min) |
| Ultimate Elongation (%) - Before Ageing | 500min (ASTM D6319-19, ASTM D412-16(2021)) | Meets ASTM D6319-19 (500min) |
| Tensile Strength (MPa) - After Aging | 14min (ASTM D6319-19, ASTM D412-06(2021)) | Meets ASTM D6319-19 (14min) |
| Ultimate Elongation (%) - After Aging | 400min (ASTM D6319-19, ASTM D412-06(2021)) | Meets ASTM D6319-19 (400min) |
| Freedom from Pinholes | AQL 2.5 Inspection Level G-1 (ASTM D5151-19) | Meets ASTM D5151-19 |
| Residual Powder | 240 minutes. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- For "Freedom from Pinholes" and "Dimensions": "Per Lot Size 500,000pcs" and "ISO 2859-1 / S2/AQL 4.0" are mentioned, indicating statistical sampling methodology from production lots rather than a fixed "test set" in the AI/ML sense. Specific N values for testing each characteristic are not given but are implied by adherence to the ASTM/ISO standards.
- For "Residual Powder": "Once every PO" (Purchase Order) indicates routine testing, not a specific "test set" size.
- For Biocompatibility and Resistance to Chemotherapy Drugs/Fentanyl: The document implies standard testing procedures were followed per ISO and ASTM D6978-05. Specific sample sizes (N) for these tests are not explicitly stated within the public summary, but are defined by the referenced standards.
- Data Provenance: The manufacturer, Eco Medi Glove Sdn. Bhd., is based in Malaysia. The testing would presumably have been conducted there or by accredited labs on behalf of the manufacturer. The data is retrospective in the sense that it represents tests performed on already manufactured gloves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device relying on human expert consensus for ground truth. The "ground truth" here is defined by performance against objective, quantitative physical and chemical test standards (e.g., tensile strength, breakthrough time, AQL for pinholes).
4. Adjudication method for the test set
Not applicable. The "ground truth" is determined by objective laboratory measurements against defined ASTM/ISO standards, not by human interpretation requiring adjudication.
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
Not applicable. This device is a physical examination glove, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical examination glove, not an AI/ML algorithm.
7. The type of ground truth used
The ground truth used consists of objective, quantitative measurements defined by international and national standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ISO 10993 series, ASTM D6978-05). These standards specify the methods and acceptable ranges for physical properties (e.g., dimensions, tensile strength, elongation), chemical properties (e.g., powder residue, chemotherapy drug permeation time), and biological response (e.g., irritation, sensitization).
8. The sample size for the training set
Not applicable. This device is a physical examination glove, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a physical examination glove, not an AI/ML algorithm.
§ 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.