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510(k) Data Aggregation
(59 days)
The Powder Free Nitrile Examination Glove (Aqua Green) is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.
The subject device in this 510(k) Notification is Powder Free Nitrile Examination Glove (Aqua Green). The subject device is a patient examination glove made from nitrile compound, Aqua Green color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Nitrile Examination Glove (Aqua Green):
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria | Reported Device Performance (Powder Free Nitrile Examination Glove (Aqua Green), K200326) |
|---|---|---|
| Product Code | 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. The device is for over-the-counter use. | Meets intended use description. |
| Material Use | Nitrile compound | Nitrile compound |
| Color | N/A (not a criterion for equivalence, but noted as different from predicate) | Aqua Green |
| Sterility | N/A | Non sterile |
| Single Use | Single used | Single used |
| Dimensions | Overall Length: Min 230mm; Width (± 5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mm; Thickness at Palm: Min 0.05 mm; Thickness at Finger Tip: Min 0.05 mm (Per ASTM D6319-10) | Meets ASTM D6319-10 (Specific values provided in another table confirm compliance with these) |
| Physical Properties (Before Aging) | Tensile Strength: 14min MPa; Ultimate Elongation: 500min % (Per ASTM D6319-10) | Meets ASTM D6319-10 (Specific values provided in another table confirm compliance with these) |
| Physical Properties (After Aging) | Tensile Strength: 14min MPa; Ultimate Elongation: 400min % (after 70ºC for 168 hrs @ 100ºC for 22 hrs) (Per ASTM D6319-10) | Meets ASTM D6319-10 (Specific values provided in another table confirm compliance with these) |
| Freedom from Pinholes | AQL 2.5, Inspection Level G-1 (Per ASTM D5151-06) | Meets ASTM D5151-06 (AQL 2.5, Inspection Level G-1) |
| Residual Powder | < 2.0 mg/pc (Per ASTM D6124-06) | Meets ASTM D6124-06 (Reported values: 0.49, 0.38, 0.43, 0.51, 0.22 mg/glove) |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10 - Primary Skin Irritation Test (Expected: non-irritant) | Under the conditions of this study, the test article was a non-irritant. |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10 - Dermal Sensitization Assay (Expected: non-sensitizer) | Under the conditions of this study, the test article was a non-sensitizer. |
| Biocompatibility (Acute Systemic Toxicity) | ISO 10993-11 - Acute Systemic Test (Expected: Not induce systemic toxicity) | Not induce systemic toxicity |
2. Sample Size Used for the Test Set and Data Provenance
The document provides details about the testing performed according to various ASTM and ISO standards for properties like dimensions, physical properties, pinholes, residual powder, and biocompatibility. However, it does not explicitly state the specific sample sizes used for each of these tests. The standards themselves would dictate the sample sizes (e.g., ISO 28590:2017 is cited for "Sampling Procedure for Inspection by Attributes").
The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing conducted for the purpose of this 510(k) submission, performed by the manufacturer or a contracted lab. The submitter's address is Malaysia, suggesting the testing likely occurred there or at a laboratory serving that region.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" for medical examination gloves is established through objective physical and chemical testing against defined industrial standards (ASTM, ISO). It does not involve expert interpretation or consensus in the same way an imaging or diagnostic AI device would.
4. Adjudication Method for the Test Set
This is not applicable. As in point 3, the assessment is based on objective measurements against established standards, not on subjective interpretations 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
This is not applicable. The device is a medical examination glove, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not applicable. The device is a physical product (glove) and does not involve any algorithm or AI.
7. The Type of Ground Truth Used
The ground truth used for this device is based on established industry standards and objective measurements. Specifically:
- Physical and Mechanical Properties: Defined by ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves), ASTM D412-16 (Tensile strength and elongation).
- Freedom from Pinholes: Defined by ASTM D5151-06.
- Residual Powder: Defined by ASTM D6124-06.
- Biocompatibility: Defined by ISO 10993-10 (Irritation and Sensitization), ISO 10993-11 (Systemic Toxicity), and 16 CFR:1500.41 (Primary Irritant Substance).
- Sampling: Guided by ISO 28590:2017.
These standards provide the quantitative and qualitative acceptance criteria against which the device's performance is measured.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product and does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. As explained in point 8, there is no training set for this type of device.
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