(117 days)
The Powder Free Nitrile Examination Gloves (Orange) is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
The proposed devices are Powder Free Nitrile Examination Gloves (Orange). The gloves are available in orange color. The proposed devices are non-sterile. The Powder Free Nitrile Examination Gloves (Orange) meet all the requirements of ASTM Specification D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided document is a 510(k) summary for "Powder Free Nitrile Examination Gloves (Orange)". This document outlines the device's characteristics and compares them to a predicate device to establish substantial equivalence, which is a regulatory pathway for medical devices. It does not describe a clinical study in the typical sense of evaluating the effectiveness or safety of a new medical treatment or diagnostic algorithm.
Instead, the document details non-clinical performance data to demonstrate that the new device (Powder Free Nitrile Examination Gloves (Orange)) meets established standards and performs similarly to a legally marketed predicate device (Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, K140418).
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| CHARACTERISTICS | STANDARDS / ACCEPTANCE CRITERIA | REPORTED DEVICE PERFORMANCE (Current Device) | Comparison to Predicate |
|---|---|---|---|
| Length | ASTM D6319 - 10(2015): Length-Min 230mm, width - min 95 ± 10 mm | Length-Min 240mm, width - min 85mm for medium glove | Same |
| Physical Properties | ASTM D6319 - 10(2015): | ||
| Before Aging: Tensile Strength min 14 MPa, Ultimate Elongation Min 500% | |||
| After Aging: Tensile Strength min 14 MPa, Ultimate Elongation Min 400% | Meets: | ||
| Before Aging: Tensile Strength Min 14 MPa, Ultimate Elongation Min 500% | |||
| After Aging: Tensile Strength min 14 MPa, Ultimate Elongation Min 400% | Same | ||
| Thickness - Finger / Palm | ASTM D6319 - 10(2015): Palm - Min 0.05mm, Finger - Min 0.05mm | Meets: Palm - Min 0.05mm, Finger - Min 0.05mm | Same |
| Powder Content | ASTM D6124 - 06(2011): ≤ 2 mg/glove | Meets: ≤ 2 mg/glove | Same |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | Passes: Under the conditions of the study, the subject device is non-irritating | Same |
| Biocompatibility (Dermal Sensitization) | ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | Passes: Under the conditions of the study, the subject device is non-sensitizing | Same |
| Watertight (1000ml) | 21 CFR 800.20, ASTM D5151: AQL 2.5 | Passes: AQL 2.5 | Same |
| Intended Use | A 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 Powder Free Nitrile Examination Gloves (Orange) is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. | Same |
| Material | ASTM D6319 - 10(2015) | Nitrile | Similar |
| Double Extra Large Size | Medical Glove Guidance Manual - Labeling | > 120mm | N/A (listed for current device only) |
| Single Use | Medical Glove Guidance Manual - Labeling | Single Use | Same |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for length, physical properties, or watertightness). However, the tests are performed according to recognized standards (ASTM, ISO, CFR), which typically specify appropriate sampling plans.
- Data Provenance: The manufacturer is "Comfort Rubber Gloves Industries Sdn. Bhd." located in Matang, Perak, Malaysia. The testing would have been conducted by or for this manufacturer. The data is prospective in the sense that these tests are performed on the manufactured product to ensure it meets the specified standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable to this type of device and study. The "ground truth" here is objective physical and chemical properties measured against established industry standards (ASTM, ISO, CFR). It does not involve expert interpretation or clinical judgment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication. The tests involve objective measurements and pass/fail criteria based on defined standards.
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 is a 510(k) submission for examination gloves, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, AI integration, or assessment of human reader improvement is relevant or performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests are established, objective performance standards and specifications documented in:
- ASTM D6319-10 (2015) - Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D6124-06 (2011) - Standard Test Method for Residual Powder on Medical Gloves
- ISO 10993-10:2010 - Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- 21 CFR 800.20 - Medical device general controls
- ASTM D5151 - Standard Test Method for Detection of Pinholes in Medical Gloves by Visual Inspection of the Inflated Glove
These standards define the acceptable range or threshold for physical properties (length, tensile strength, elongation, thickness), chemical properties (powder content), biological reactions (biocompatibility), and integrity (watertightness).
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this device. The gloves are manufactured and then tested against established standards.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8. The standards themselves are developed through industry consensus, scientific research, and regulatory requirements, not through a "training set" for an 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.