(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 Black Nitrile Powder Free Medical Examination Glove is a single use, disposable device made from a nitrile latex compound, black in color, powder free and non-sterile.
The provided document is a 510(k) Pre-Market Notification for a medical device, specifically the "SBG Black Nitrile Powder Free Medical Examination Glove" (K180468).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison table (page 5) between the proposed device (SBG Black Nitrile Powder Free Medical Examination Glove, K180468) and a predicate device (EMG Black Nitrile Medical Examination Glove Powder Free, K141579). This table serves as the primary source for acceptance criteria and reported performance for the proposed device, demonstrating equivalence to the predicate.
| Characteristics | Acceptance Criteria (from Predicate/Standards) | Proposed Device Performance (SBG Black Nitrile Powder Free Medical Examination Glove K180468) | Comparison Status |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Intended Use | A 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 device is for over-the-counter use. | A powder free 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. The device is for over-the-counter use. | Same |
| Material Use | Not made from Natural Rubber Latex | Nitrile latex compound | Same |
| Color | Black | Black | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Dimensions | |||
| Overall Length (mm) | 220 mm = (sizes XS-S), 230 mm = (sizes M-XL) (Standard) | 272 mm Minimum All Sizes | Similar (Proposed device exceeds minimums) |
| Width (± 10 mm) | Size S = 80 mm, Size M = 95 mm, Size L = 110 mm, Size XL = 120 mm (Standard) | Size S = 70-90 mm, Size M = 85-105 mm, Size L = 100-120 mm, Size XL = 110-130 mm | Similar (Proposed device falls within ranges) |
| Thickness at Finger (mm) | All Sizes = 0.05 mm (Standard) | 0.16 mm Minimum All Sizes | Similar (Proposed device exceeds minimum) |
| Thickness at Palm (mm) | All Sizes = 0.05 mm (Standard) | 0.14 mm Minimum All Sizes | Similar (Proposed device exceeds minimum) |
| Physical Properties Before Aging (ASTM 6319-10 (D 412)) | |||
| Tensile Strength (MPa) | ≥ 14 min. | ≥ 14 | Same |
| Ultimate Elongation (%) | ≥ 500 min. | 500 min. | Same |
| Physical Properties After Aging (ASTM 6319-10 (D573) - 70°C ± 2 °C for 166 hrs ± 2 hrs.) | |||
| Tensile Strength (MPa) | ≥ 14 min. | ≥ 14 | Same |
| Ultimate Elongation (%) | ≥ 500 min. | 500 min. | Similar |
| Freedom from Holes (D 5151) | AQL 2.5 Inspection Level G-1, Accept at 5 failures, Reject at 6 failures | AQL 2.5 Inspection Level G-1, Pass | Same |
| Residual Powder (D 6124) | ≤ 2.0 mg/pc | Contains less than 2.0 mg | Same |
| Biocompatibility Test - Primary Skin Irritation Test (ISO 10993-10:2010 (E)) | (Implicit: not a primary skin irritant) | Under the conditions of the study, not a primary skin irritant. | Same |
| Biocompatibility Test - Dermal Sensitization Assay (ISO 10993-10:2010 (E)) | (Implicit: not a contact sensitizer) | Under conditions of the study, not a contact sensitizer | Same |
| Safety Assessment (Systemic Toxicity) | (Implicit: acceptable health risk) | The results from the safety assessment demonstrated the device presents a low potential health risk | Different (Predicate not shown, but implies satisfactory result) |
Note on "Acceptance Criteria": For characteristics where a numerical value is given (e.g., Tensile Strength), that is the explicit acceptance criteria. For qualitative characteristics (e.g., Material Use, Color), the "Acceptance Criteria" column reflects the shared characteristic with the predicate or a general industry expectation. For biocompatibility and safety assessments, the criteria are implied to be "not a primary skin irritant," "not a contact sensitizer," and "low potential health risk," respectively.
2. Sample size used for the test set and the data provenance
The document refers to various ASTM and ISO standards for testing (e.g., D 412, D 573, D 5151, D 6124, ISO 10993-10:2010 (E)). These standards often specify sample sizes for their respective tests. However, the exact sample sizes used for each test performed on the proposed device are not explicitly stated in this summary.
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is assumed these were prospective tests performed by the manufacturer or contracted labs to verify the device's conformance to standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to the evaluation of this device. The device is a "Patient Examination Glove," which is a Class I device and its performance is assessed through physical, chemical, and biological testing against established standards, not through expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human interpretation or subjective assessments. The tests for a medical examination glove are objective measurements against predefined standards.
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 information is not applicable. The device is an examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. As mentioned above, the device is a physical examination glove, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is based on established national and international standards for medical examination gloves (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10). These standards define the acceptable physical properties (tensile strength, elongation, dimensions), freedom from holes, residual powder levels, and biocompatibility.
8. The sample size for the training set
This information is not applicable. The concept of a "training set" refers to data used to train machine learning models. This device is a physical product and does not involve machine learning.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
§ 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.