(33 days)
This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Class I Nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of the ASTM Draft Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided text describes the acceptance criteria and the study that proves the device, SMART SHIELD™ POWDER FREE COLORED NITRILE EXAMINATION GLOVES WITH BUBBLE GUM SCENT, meets these criteria.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimension | ||
| Width | Small: 80 mm +/- 10mm (ASTM D3578-95) | Small: 80 - 85 mm |
| Medium: 90 mm +/- 10mm (ASTM D3578-95) | Medium: 90 - 97 mm | |
| Medium-Large: 100mm +/- 10mm (ASTM D3578-95) | Medium-Large: 105 - 110 mm | |
| Large: 111mm +/- 10mm (ASTM D3578-95) | Large: 111 - 114 mm | |
| Length | 230 mm minimum for all sizes (ASTM D3578-95) | 240 mm minimum for all sizes |
| Thickness (Finger) | 0.08 mm minimum (ASTM D3578-95) | 0.08 mm minimum |
| Thickness (Palm) | 0.08 mm minimum (ASTM D3578-95) | 0.08 mm minimum |
| Tensile Strength (Before Aging) | 14.0 MPa (ASTM D3578-95); 12.5 MPa (ASTM DRAFT NITRILE) | 18.0 MPa |
| Tensile Strength (After Aging) | 14.0 MPa (ASTM D3578-95); 12.5 MPa (ASTM DRAFT NITRILE) for 22 HRS @ 100°C | 16.0 MPa |
| Ultimate Elongation (Before Aging) | 700% (ASTM D3578-95); 500% (ASTM DRAFT NITRILE) | 600% |
| Ultimate Elongation (After Aging) | 500% (ASTM D3578-95); 400% (ASTM DRAFT NITRILE) for 22 HRS @ 100°C | 500% |
| Water Tight Test | Meets FDA Water Leak Test Requirements (G1 single sampling plan with 1,000 ml water leak test for 200 pieces of each size, per ASTM D 5151-90) | Small: 4 leaks out of 200; Medium: 1 leak out of 200; M-Large: 2 leaks out of 200; Large: 3 leaks out of 200. (All considered to meet requirements). |
| Biocompatibility - Primary Dermal Irritation Test | Passes Biocompatibility Requirements | Passes |
| Biocompatibility - Skin Sensitization Study | Passes Biocompatibility Requirements | Passes |
| Residual Powder Content | Not exceeding 2 mg per glove (FDA internal requirements; measured by ASTM D 6124) | Range: 1.4-1.9 mg/glove; Mean: 1.7 mg per glove |
| Cornstarch Presence | Negative (Iodine Test) | Negative |
2. Sample Size Used for the Test Set and Data Provenance
For the water-tightness test, the sample size used was 200 pieces for each glove size (Small, Medium, M-Large, Large). This suggests a total of 800 gloves were tested for water tightness.
The data provenance is from the manufacturer's internal testing (Shield Gloves Mfr's), conducted to meet FDA and ASTM standards. The specific country of origin is Malaysia (Shield Gloves Manufacturer (M) Sdn. Bhd.). The data appears to be prospective as it involves direct testing of manufactured batches.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing ground truth for any of the tests. The tests performed (dimension, physical properties, water leak, biocompatibility, residual powder) are objective measurements against established ASTM and FDA standards, not subjective expert assessments.
4. Adjudication Method for the Test Set
No adjudication method is described, as the tests rely on objective measurements and pass/fail criteria against predefined standards (ASTM, FDA). There is no indication of a need for expert adjudication for these specific performance metrics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation of results (e.g., radiology images) to assess the impact of AI on human reader performance. For examination gloves, the performance metrics are largely objective and physical.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are all standalone performance evaluations of the glove itself. There is no algorithm or human-in-the-loop component relevant to the testing presented. The device is a physical product, not an AI or software-as-a-medical-device.
7. The Type of Ground Truth Used
The ground truth for all evaluated parameters were established standards and specifications:
- ASTM D3578-95 and ASTM DRAFT NITRILE for dimensions, tensile strength, and ultimate elongation.
- FDA specified 1,000 ml water leak test and ASTM D 5151-90 for water tightness.
- FDA biocompatibility requirements for primary dermal irritation and skin sensitization.
- FDA internal requirements (not exceeding 2 mg/glove) for residual powder content, measured by ASTM D 6124.
- Negative Iodine test for cornstarch presence.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical product (nitrile gloves) and not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above; there is no training set for a physical medical glove.
§ 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.