(259 days)
MPXX™ Powder Free Natural Rubber Latex Examination Gloves are intended for single use for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
MPXX™™ Powder Free Natural Rubber Latex Examination Gloves are substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D-3578-05, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. They are natural white in color and are powder free.
The provided document is a 510(k) premarket notification for MPXX™ Powder Free Natural Rubber Latex Examination Gloves, demonstrating substantial equivalence to a predicate device (K981767). It describes the device's technical characteristics and the non-clinical tests performed.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally aligned with ASTM D 3578-05 (Standard Specification for Rubber Examination Gloves) and 21 CFR 800.20. The reported device performance indicates that the MPXX™ gloves meet or exceed these specifications.
| Characteristic/Parameter | Acceptance Criteria (from Predicate Device - ASTM D 3578-95 unless otherwise specified) | Reported Device Performance (MPXX™ Gloves) | Result |
|---|---|---|---|
| Product Code | 80LYY | 80LYY | Meets |
| Intended Use | Single use device for medical purposes, worn on the hand of healthcare personnel to prevent contamination between healthcare personnel and patient. | Same as acceptance criteria | Meets |
| Glove Thickness (Palm) | ≥ 0.08mm (ASTM D 3578-95) | Meets ASTM D 3578-05: ≥ 0.08mm | Meets (and updated ASTM standard) |
| Glove Thickness (Finger) | ≥ 0.08mm (ASTM D 3578-95) | Meets ASTM D 3578-05: ≥ 0.08mm | Meets (and updated ASTM standard) |
| Glove Length | ≥ 230mm (ASTM D 3578-95) | Meets ASTM D 3578-05: ≥ 240mm | Meets (and exceeds length requirement) |
| Tensile Strength | ≥ 14MPa (ASTM D 3578-95) | Meets ASTM D 3578-05: ≥ 18MPa | Meets (and exceeds strength requirement) |
| Elongation | ≥ 700% (ASTM D 3578-95) | Meets ASTM D 3578-05: ≥ 650% | Meets (Note: The predicate states ≥ 700% while the subject states ≥ 650%. Both state they meet ASTM D 3578-05 for the subject and ASTM D 3578-95 for the predicate, which implies a potential standard revision or slightly different interpretation. However, the document asserts "Substantial Equivalence"). |
| Freedom from Holes (AQL) | AQL 1.5 (21CFR800.20, with ASTM D 3578-05 requiring AQL 2.5) | Gloves Free of Holes at quality level of AQL 1.5 (AQL 2.5 required per standard) | Meets (and exceeds standard requirement by having a tighter AQL) |
| Materials | Natural Rubber Latex | Natural Rubber Latex | Meets |
| Color | Natural Color | Natural Color | Meets |
| Biocompatibility | Passes: Primary Skin Irritation; Dermal Sensitization | Passes: Primary Skin Irritation; Dermal Sensitization | Meets |
| Powder Free | ≤ 2 mg per glove | ≤ 2 mg per glove | Meets |
| Protein Content | ≤ max 50 (ug/dm²) | ≤ max 50 (ug/dm²) | Meets |
| Sterility | Non-sterile | Non-sterile | Meets |
Study Proving Acceptance Criteria is Met:
The study proving the device meets the acceptance criteria is a non-clinical testing program performed according to the requirements of ASTM D 3578-05, "Standard Specification for Rubber Examination Gloves," and 21 CFR 800.20. Additionally, biocompatibility testing was conducted.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for each specific test (e.g., number of gloves tested for tensile strength, AQL, or thickness). The ASTM standards typically define sampling plans, but the specifics are not provided in this summary.
- Data Provenance: The testing was performed by TOTAL GLOVE COMPANY SDN. BHD., located in Malaysia. The tests are non-clinical, laboratory-based. The data is prospective in the sense that it was generated for this specific 510(k) submission to demonstrate conformity with standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the ground truth for glove performance (e.g., tensile strength, dimensions, freedom from holes, biocompatibility) is established by objective, standardized laboratory measurements against defined ASTM and CFR specifications, not by expert consensus or interpretation of visual data.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation is based on objective, quantitative measurements against established standards, not on subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This device is an examination glove, not an AI-assisted diagnostic tool, so such a study would not be relevant. The submission states, "No new clinical tests were conducted under this 510(k)."
6. Standalone Performance Study
Yes, a standalone study (algorithm only without human-in-the-loop performance) was effectively done. The non-clinical tests described are for the device (the glove) itself, without human interaction influencing the measurement of its physical and biological properties. The tests (e.g., tensile strength, elongation, thickness, freedom from holes, biocompatibility, protein content, powder level) are direct measurements of the glove's attributes.
7. Type of Ground Truth Used
The ground truth used for evaluating the device's performance is based on established industry standards and regulatory requirements, specifically:
- ASTM D 3578-05: Standard Specification for Rubber Examination Gloves.
- 21 CFR 800.20: Regulations for medical device performance.
- Biocompatibility Standards: Primary skin irritation testing and delayed contact sensitization testing (which are also often guided by ISO 10993 series or similar standards, though not explicitly named in the brief summary).
- USP Iodine Test: For the absence of starch.
These standards define the acceptable range or threshold for each characteristic.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device (examination glove), not an artificial intelligence or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, there is no training set for this type of 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.