(213 days)
The Non-sterile Powder Free Black Nitrile Examination Gloves , 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.
Class I Nitrile examination gloves 80LZA, powder free and meeting all the requirements of ASTM D6319-00aE3 Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided document describes the safety and effectiveness summary for Non-Sterile, Powder Free Black Nitrile Examination Gloves, which are classified as a Class I medical device. The document focuses on demonstrating substantial equivalence to a predicate device (K000868) by meeting established industry standards for examination gloves.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Required Performance | Reported Device Performance | Study Type/Method |
|---|---|---|---|
| ASTM D6319-00aE3, Standard Specification For Nitrile Gloves. | Meeting all requirements of ASTM D6319-00aE3 | Meets the requirements of ASTM D6319-00aE3 | Implied through compliance statement. Specific tests include: |
- Tensile Strength
- Elongation
- Dimensions (Length, Palm Width, Finger Thickness) |
| 1SO 2859-1, Standard for Water Leak Test and/or ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves. | Detection of holes in medical gloves | Meets the requirements of ISO 2859-1 and/or ASTM D5151-06 (Water Leak Test) | Water Leak Test (specifics of sample size/method not detailed beyond standard reference) |
| ASTM D6124-06, Standard Test Method for Residual Powder on Medical Gloves. | Measurement of residual powder | Meets the requirements of ASTM D6124-06 (Residual Powder Test) | Residual Powder Test (specifics of sample size/method not detailed beyond standard reference) |
| Biocompatibility Testing | Biocompatibility on White rabbits and Guinea pigs (absence of irritation/sensitization) | Meets Biocompatibility Testing on White rabbits and Guinea Pigs | Biocompatibility testing (specifics of tests/sample size not detailed beyond animal models) |
| Labeling | Meets FDA Specifications | Meets FDA Specifications | Labeling review against FDA guidelines |
| Equivalence to Predicate Device (K000868) | Substantially equivalent to K000868 (except for color) | Substantially equivalent to K000868 (except for color) | Comparative review against predicate device specifications |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., water leak, residual powder, tensile strength). It refers to compliance with the standards, implying that the sample sizes and methods prescribed within those standards were followed.
- Data Provenance: The manufacturing company is based in Thailand (SGMP Company Limited, 181 Moo 6, Tambol Kampacngpotch, Rattaphum, Songkhla 90180, Thailand). It is likely that the testing data was generated in Thailand or by laboratories compliant with international standards, but the exact country of origin for the data is not explicitly stated. The studies are retrospective in the sense that they were conducted on the manufactured product to demonstrate compliance with existing standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in this context. The "ground truth" for medical gloves is established by meeting predefined physical and chemical performance standards (e.g., ASTM, ISO standards) rather than by expert clinical consensus or interpretation of diagnostic images. The standards themselves define the acceptable parameters for mechanical properties, barrier integrity, and biocompatibility.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication typically refers to resolving discrepancies in expert opinions, which is not relevant for testing physical properties of a device against objective standards. The outcome of the tests (e.g., does it leak or not, what is the tensile strength) is typically a quantifiable measurement or a pass/fail determination based on predefined thresholds in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. The device is a physical medical glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.
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 medical glove, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of these gloves is defined by:
- Performance Standards: The specifications outlined in ASTM D6319-00aE3, ISO 2859-1, ASTM D5151-06, and ASTM D6124-06. These standards define the acceptable physical properties (e.g., tensile strength, elongation), barrier integrity (water leak test), and chemical characteristics (residual powder).
- Biocompatibility Standards: Established protocols for testing biological reactions on animal models (White rabbits and Guinea pigs).
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device, not a machine learning model. There is no "training set." The manufacturing process is subject to quality control, and batches of gloves are sampled for testing against the standards.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
§ 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.