(231 days)
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
The SBG Blue Nitrile Powder Free Medical Examination Glove is a single use, disposable device made from a nitrile latex compound. Blue in color, powder free and non-sterile.
The provided document is a 510(k) summary for a medical device called "SBG Blue Nitrile Powder Free Medical Examination Glove." This document outlines the device's characteristics, its comparison to a predicate device, and the results of various non-clinical tests to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria | Proposed Device Performance (SBG Blue Nitrile Powder Free Medical Examination Glove) | Predicate Device Performance (EMG Blue Nitrile Medical Examination Glove Powder Free) | Comparison |
|---|---|---|---|---|
| Product Code | LZA | LZA | LZA | Same |
| Intended Use | Disposable device for medical purposes, worn on hands/fingers to prevent contamination, for over-the-counter use. | Matches acceptance criteria description. | Matches acceptance criteria description. | Same |
| Material Use | Not made from Natural Rubber Latex | Nitrile latex compound | Nitrile latex compound | Same |
| Color | Blue | Blue | Blue | Same |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Dimensions: Overall Length (mm) | 220 mm (sizes XS-S), 230 mm (sizes M-XL) | Size Medium: 234 mm | Size Medium: 245 mm | Same |
| Dimensions: Width (± 10 mm) | Size S = 80 mm, Size M = 95 mm, Size L = 110 mm, Size XL = 120 mm | Size Medium: 97 mm | Size Medium: 94 mm | Same |
| Dimensions: Thickness at Finger (mm) | All Sizes = 0.05 mm | 0.11 mm | 0.17 mm | Same |
| Dimensions: Thickness at Palm (mm) | All Sizes = 0.05 mm | 0.10 mm | 0.10 mm | Same |
| Physical Properties | ||||
| Tensile Strength (MPa) | 14 min. | 37 | 34 | Same |
| Ultimate Elongation (%) | 500 min. | 590 | 600 | Same |
| After Aging (ASTM 6319-10 (D573) - 70°C ± 2 °C for 166 hrs ± 2 hrs.): Tensile Strength (MPa) | 14 min. | 38 | 30 | Same |
| After Aging: Ultimate Elongation (%) | 500 min. | 533 | 560 | Same |
| Freedom from Holes (D 5151) | AQL 2.5 Inspection Level G-1, Accept at 5 failures, Reject at 6 failures | Meets ASTM D5151-06 | Meets ASTM D5151-06 | Same |
| Residual Powder (D 6124) | ≤ 2.0 mg/pc | 0.18 mg | 0.20 mg | Same |
| Biocompatibility | ||||
| Primary Skin Irritation Test (ISO 10993-10:2010 (E)) | (Implicitly: not a primary skin irritant) | Under the conditions of the study, not a primary skin irritant. | Under the conditions of the study, not a primary skin irritant. | Same |
| Dermal Sensitization Assay (ISO 10993-10:2010 (E)) | (Implicitly: not a contact sensitizer) | Under conditions of the study, not a contact sensitizer. | Under conditions of the study, not a contact sensitizer. | Same |
| Safety Assessment (Systemic Toxicity) | (Implicitly: low potential health risk) | The results from the safety assessment demonstrated the device presents a low potential health risk. | / (Not explicitly stated for predicate in table, but implied by "Same" in other biocompatibility tests) | Different (Table shows a "/" for predicate implying direct data not provided in this row) |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the specific sample sizes used for each test (e.g., freedom from holes, physical properties, biocompatibility) or their data provenance (country of origin, retrospective/prospective). However, for tests like "Freedom from Holes (D 5151)," it mentions an "AQL 2.5 Inspection Level G-1," which implies a statistically defined sampling plan as per ASTM D5151-06. The standard for biocompatibility tests (ISO 10993-10) also specifies testing guidelines.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The document describes non-clinical tests (physical properties, biocompatibility) of a medical examination glove, which typically rely on standardized testing protocols rather than expert consensus on a test set (as would be the case for AI/imaging devices).
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided in the document. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation or subjective assessments, particularly in AI models for medical imaging. The tests described here are objective, quantitative measurements of material properties and biological responses.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic or interpretive tools to assess how human readers' performance changes with AI assistance. The device in question is a physical glove, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone study as defined for AI algorithms was not done. The device is a physical product, and its performance is evaluated based on its material properties and safety characteristics, not an algorithm's output.
7. The Type of Ground Truth Used:
The "ground truth" for the tests described are objective physical and chemical measurements and biological responses as defined by specific ASTM and ISO standards. For example:
- Freedom from Holes: Defined by the ASTM D5151-06 standard and its specified AQL (Acceptance Quality Limit).
- Tensile Strength & Ultimate Elongation: Measured according to material testing standards.
- Residual Powder: Measured according to ASTM D6124.
- Biocompatibility (Primary Skin Irritation, Dermal Sensitization): Determined by standardized animal or in-vitro tests following ISO 10993-10:2010 (E) protocols. The outcomes (e.g., "not a primary skin irritant") serve as the ground truth based on the established biological criteria of these tests.
8. The Sample Size for the Training Set:
This concept is not applicable to this device. A "training set" is used for machine learning algorithms. This device is a physical glove, not an AI model, and therefore does not have a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set 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.