(206 days)
Prepowdered latex examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Prepowdered latex examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Latex Examination Gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | ||
| Length (XS, S, M, L, XL) | 240 mm (min.) | 240 mm (min.) |
| Palm Width (XS) | 75 ± 5 mm | 75 ± 5 mm |
| Palm Width (S) | 80 ± 10 mm | 80 ± 10 mm |
| Palm Width (M) | 95 ± 10 mm | 95 ± 10 mm |
| Palm Width (L) | 105 ± 10 mm | 105 ± 10 mm |
| Palm Width (XL) | 115 ± 5 mm | 115 ± 5 mm |
| Cuff Thickness | 0.10 mm (min.) | 0.10 mm (min.) |
| Palm Thickness | 0.10 mm (min.) | 0.10 mm (min.) |
| Finger Tip Thickness | 0.10 mm (min.) | 0.10 mm (min.) |
| Physical Properties | ||
| Tensile Strength (Before Ageing) | 14 Mpa (min.) | 14 Mpa (min.) |
| Ultimate Elongation (Before Ageing) | 650 % (min.) | 650 % (min.) |
| Tensile Strength (After Ageing at 70°C for 168 hrs) | 14 Mpa (min.) | 14 Mpa (min.) |
| Ultimate Elongation (After Ageing at 70°C for 168 hrs) | 500 % (min.) | 500 % (min.) |
| Performance Requirements | ||
| Sterility | Fails sterility: AQL N/A, Inspection Level A (Implies 0 defects) | Meets the sterility assurance level. |
| Freedom from holes | Holes: AQL 2.5, Inspection Level 1 | Meets FDA pinhole requirement. |
| Dimensions & Thickness | Width Length: AQL 4, Inspection Level S-2 | Device is reported to meet the specified dimensions. |
| Physical Properties after ageing | Before and (after ageing): AQL 4, Inspection Level S-2 | Device is reported to meet the specified physical properties. |
| Powder Free Residue | Exceeds Maximum Limit: AQL N/A, N=5 | Meets labeling claim (implicitly includes residue). |
| Protein Content | Exceeds Recommended Maximum Limit: AQL N/A, N=3 (Labeling Claim: 50 ug or less) | Meets protein content labeling claim (50ug or less). |
| Powder Amount | Exceeds Recommended Maximum Limit: AQL N/A, N=2 | (Implicitly met by labeling claim and ASTM D 3578-01) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a consolidated sample size for a single "test set" in the context of a clinical trial or algorithm evaluation. Instead, it refers to differing sample sizes/inspection levels (e.g., N=5 for Powder Free Residue, N=3 for Protein Content, N=2 for Powder Amount, Inspection Level 1 for holes) for various performance requirements.
The data provenance is presented as internal testing and conformity to standards. The document is from Indonesia, suggesting the testing was likely conducted in Indonesia. The data is retrospective in the sense that the results are presented as already achieved and certified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of device and study. The "ground truth" for gloves is adherence to specified physical and chemical properties and performance standards (like ASTM D 3578-01). This is determined by laboratory testing against objective criteria, not by expert consensus.
4. Adjudication Method for the Test Set
Not applicable. Laboratory tests against established standards do not typically involve adjudication methods like those used in clinical image interpretation. Results are quantitatively measured and compared against defined thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, often with AI assistance. For examination gloves, the performance is assessed through laboratory testing of material properties and barrier integrity.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical product (examination gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for evaluating the device's performance is based on:
- Standard Specifications: Specifically, the ASTM D 3578-01 standard for latex examination gloves, which defines dimensions, physical properties (tensile strength, elongation), and barrier integrity.
- Regulatory Requirements: FDA pinhole requirements and sterility assurance levels.
- Labeling Claims: The manufacturer's specific claim of "50ug or less" for protein content.
These are all objective, quantifiable metrics determined by laboratory testing.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI/ML model that requires a training set. The term "training set" is not relevant here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as 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.