(262 days)
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner
Blue Nitrile Examination gloves powder free with Peppermint Scented , non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound, Blue color, Powder free and non sterile.
The provided document is an FDA 510(k) Premarket Notification for a medical device: "EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint Scented." This document focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than proving superiority or conducting complex clinical studies for a novel AI/software device.
Therefore, the specific information requested about acceptance criteria for AI/software, multi-reader studies, ground truth establishment for training sets, etc., as typically applied to AI/ML medical devices, is not applicable to this submission for examination gloves.
However, I can extract and present the acceptance criteria and performance data for the examination gloves as presented in the document, which are primarily based on physical properties and biocompatibility testing against established ASTM standards.
Here's the information derived from the document, tailored to the context of examination gloves:
Acceptance Criteria and Device Performance for EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint Scented
The device is an examination glove, and its performance is evaluated against established industry standards (primarily ASTM D6319-10 for Nitrile Examination Gloves and ISO 10993-10 for biocompatibility) and compared to a predicate device. The goal of this 510(k) submission is to demonstrate "substantial equivalence" rather than a superior clinical outcome delivered by an AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
The following table summarizes the key performance characteristics and their corresponding acceptance criteria, along with the reported performance of the EMG Powder Free Nitrile Examination Glove. The predicate device's performance is also included for comparative purposes, as the entire submission is based on demonstrating equivalence.
| Characteristic | Acceptance Criteria (Standards/Specifications) | Reported Device Performance (EMG Glove) | Predicate Device Performance (K070097) |
|---|---|---|---|
| General | |||
| Product Code | LZA (Patient Examination Glove) | LZA | LZA |
| Intended Use | A powder free 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. | Meets the specified intended use. | Meets the specified intended use. |
| Type of Use | Over-the-counter use. | For over-the-counter use. | For over-the-counter use. |
| Material Use | Not made from Natural Rubber Latex. | Nitrile latex compound. | Nitrile latex compound. |
| Color | Peppermint Scented, blue Color. | Peppermint Scented, blue Color. | Peppermint Scented, blue Color. |
| Sterility | Non-sterile. | Non-sterile. | Non-sterile. |
| Physical Dimensions | (Meets ASTM D6319-10) | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Overall Length (mm) | ≥ 230 min (for all sizes S, M, L, XL) | 230mm min | (Implied to meet ASTM D6319-10) |
| Width (± 5mm) | Size S = 85mm; Size M = 95mm; Size L = 105mm; Size XL = 115mm | S=85, M=95, L=105, XL=115 | (Implied to meet ASTM D6319-10) |
| Thickness at Palm (mm) | ≥ 0.05 min | 0.05mm min | (Implied to meet ASTM D6319-10) |
| Thickness at Finger Tip (mm) | ≥ 0.05 min | 0.05mm min | (Implied to meet ASTM D6319-10) |
| Physical Properties | (Meets ASTM D6319-10) | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Tensile Strength (MPa) - Before Aging | ≥ 14 min | 14 min | (Implied to meet ASTM D6319-10) |
| Ultimate Elongation (%) - Before Aging | ≥ 500 min | 500 min | (Implied to meet ASTM D6319-10) |
| Tensile Strength (MPa) - After Aging (70°C for 168 hrs / 100°C for 22 hrs) | ≥ 14 min | 14 min | (Implied to meet ASTM D6319-10) |
| Ultimate Elongation (%) - After Aging (70°C for 168 hrs / 100°C for 22 hrs) | ≥ 400 min | 400 min | (Implied to meet ASTM D6319-10) |
| Freedom from Pinhole | AQL 2.5 (Inspection Level G-1) (Meets ASTM D5151-06) | AQL 2.5, Inspection Level G-1 | Meets ASTM D5151-06 |
| Residual Powder | ≤ 2.0 mg/pc (Meets ASTM D6124-06) | ≤ 2.0 mg/pc | Meets ASTM D6124-06 |
| Biocompatibility | |||
| Primary Skin Irritation Test | Non-irritant per ISO 10993-10. | The test article is a non-irritant per ISO 10993-10. | Under the conditions of this study, the test article was a non-irritant. |
| Dermal Sensitization Assay | Non-sensitizer per ISO 10993-10. | The test article is a non-sensitizer per ISO 10993-10. | Under the conditions of this study, the test article was a non-sensitizer. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes (e.g., number of gloves) for each specific physical and biocompatibility test performed. However, it indicates adherence to ASTM standards (e.g., ASTM D6319-10, ASTM D5151-06, ASTM D6124-06) and ISO 10993-10. These standards specify sampling plans and test methodologies.
- Data Provenance: The tests would have been performed on samples of the manufactured EMG Powder Free Nitrile Examination Glove. The manufacturer, Eco Medi Glove Sdn. Bhd., is based in Malaysia. The testing described is retrospective in the sense that it's performed on finished product samples to demonstrate compliance with standards for market clearance, rather than a clinical trial on patients.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This concept is not applicable to this type of device submission. Examination gloves are physical products evaluated against standardized engineering and biological performance tests, not against interpretations of medical images or other data where expert consensus is needed to establish "ground truth." The "ground truth" is the objective measurement of physical properties (e.g., tensile strength, dimensions, pinholes) and biological responses (e.g., irritation, sensitization) following well-defined test protocols.
4. Adjudication Method for the Test Set
This concept is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, often for medical imaging, to resolve disagreements among reviewers. The testing for examination gloves is based on objective, quantifiable measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids where the impact of the AI on human reader performance is evaluated. For examination gloves, the safety and effectiveness are tied to their physical properties and biocompatibility, not to how they might assist human interpretation of data.
6. If a Standalone (Algorithm Only) Performance Study was Done
No, a standalone performance study (algorithm only) was not done. This submission is for a physical medical device (examination gloves), not an artificial intelligence algorithm.
7. The Type of Ground Truth Used
The "ground truth" for examination gloves is established through adherence to recognized industry standards and laboratory testing protocols. This includes:
- Engineering/Physical Standards: ASTM D6319-10 for physical characteristics (dimensions, tensile strength, elongation), ASTM D5151-06 for pinhole levels, and ASTM D6124-06 for residual powder.
- Biocompatibility Standards: ISO 10993-10 for primary skin irritation and dermal sensitization.
The "ground truth" is the objective measurement result from these standardized tests, which is then compared against the predetermined acceptance criteria within the standards.
8. The Sample Size for the Training Set
This concept is not applicable. This device is not an AI/ML algorithm that requires a "training set." The product is manufactured and then tested to ensure it meets pre-defined specifications.
9. How the Ground Truth for the Training Set was Established
This concept is not applicable as there is no "training set" for this physical 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.