(95 days)
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
Non-Sterile, Powder Free Nitrile Examination Gloves - Blue meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for overthe counter single use.
The provided document is a 510(k) premarket notification for a medical device: "Powder Free Nitrile Examination Glove". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials or a specific study designed to meet detailed acceptance criteria typical of novel AI/ML devices. Therefore, the questions related to AI/ML device studies (such as MRMC studies, ground truth establishment for AI training/test sets, effect sizes of AI assistance, and number of experts for ground truth) are not applicable to this document.
For this conventional medical device, the "acceptance criteria" are essentially the performance standards outlined in ASTM Specification D6319-10 and other relevant tests for patient examination gloves. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing conducted by the manufacturer.
Here's an interpretation of the document in the context of the requested information, noting the inapplicable fields:
Acceptance Criteria and Device Performance for Powder Free Nitrile Examination Glove (K171667)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on ASTM Specification D6319-10. The performance data for the subject device (K171667) is compared to these ASTM standards (or implied standards based on the predicate device's specifications).
| Characteristics and Parameters | Acceptance Criteria (from ASTM/Predicate) | Reported Device Performance (K171667) | Comparison/Status |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Intended Use | Prevention of contamination between patient and examiner | Prevention of contamination between patient and examiner | Same |
| Classification | Class I | Class I | Same |
| Raw Rubber Material | Nitrile (Acrylonitrile-butadiene) | Nitrile (Acrylonitrile-butadiene) | Same |
| Surface Appearance | Blue, Ambidextrous, Finger Textured | Blue, Ambidextrous, Finger Textured | Similar |
| Overall Length Minimum | 230mm | Average: 242 mm | Meets/Similar |
| Width (S, M, L) | S: 75-95mm, M: 85-105mm, L:100-120mm | S: 85mm, M: 95mm, L: 104mm | Meets/Similar |
| Palm Thickness (Minimum) | 0.05mm | Average: 0.06mm | Meets/Similar |
| Finger Thickness (Minimum) | 0.05mm | Average: 0.07mm | Meets/Similar |
| Tensile Strength (before age) | Minimum 14 MPa | Average: 17.44 MPa | Meets/Similar |
| Tensile Strength (After Age) | Minimum 14 MPa | Average: 16.37 MPa | Meets/Similar |
| Ultimate Elongation (before age) | Minimum 500% | Average: 559% | Meets/Similar |
| Ultimate Elongation (after age) | Minimum 400% | Average: 508% | Meets/Similar |
| Freedom of Holes | Meet AQL 2.5 at G1 | Meet AQL 1.5 with G1 | Meets/Same (better) |
| Residual powder test (per glove) | Less than 2mg/glove | S: 0.43 mg/glove, M: 0.31 mg/glove, L: 0.47 mg/glove | Meets/Similar |
| Primary Skin Irritation | Not an irritant (under study conditions) | Not an irritant | Same |
| Dermal Sensitization | Not a sensitizer (under study conditions) | Not a sensitizer | Same |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for Freedom of Holes, tensile strength, etc.). However, it indicates that the tests conform to ASTM standards (e.g., ASTM Specification D6319-10), which would prescribe appropriate sample sizes for such physical and chemical tests.
- Data Provenance: The manufacturer, Professional Latex Sdn Bhd, is based in Malaysia ("Kamunting, Perak"). The testing would have been conducted by or for the manufacturer. The data is retrospective in the sense that the tests were performed and results collected before the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as this is a physical medical device (examination gloves), not an AI/ML diagnostic or image analysis device that requires expert human interpretation for "ground truth". The "ground truth" for these tests are the objective measurements (e.g., tensile strength, dimensions, water leak test results).
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or expert review processes for subjective assessments (e.g., image interpretation), which is not relevant for the objective physical and chemical tests of gloves.
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 question is not applicable. This is not an AI/ML device, and no MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on objective physical, chemical, and biological test measurements as per recognized standards (e.g., ASTM D6319-10). Examples include:
- Physical measurements: Length, width, thickness (using calipers/micrometers).
- Mechanical properties: Tensile strength, ultimate elongation (using a universal testing machine).
- Barrier integrity: Freedom of holes (water leak test, AQL).
- Chemical analysis: Residual powder (gravimetric analysis).
- Biocompatibility: Primary skin irritation, dermal sensitization (in vivo animal or in vitro tests).
8. The Sample Size for the Training Set
This question is not applicable. This is not an AI/ML device, so there is no "training set." The glove manufacturing process involves quality control and testing of product batches.
9. How the Ground Truth for the Training Set was Established
This question is not applicable. As there is no "training set" in the AI/ML sense, this process is irrelevant for this 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.