(125 days)
Comfortpro latex examination powder free gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
COMFORTPRO Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are Natural in color (No color added) and are powder free.
This is a 510(k) summary for a medical device, specifically, a latex examination glove. The document describes the device's characteristics and compares them against a predicate device and established performance standards.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria (Predicate) | Device Performance (Current) | Comparison |
|---|---|---|---|---|
| Dimensions - Length | ASTM D3578-19 | Min 230 mm for all sizes | Overall: Length > 230 mm | |
| X-Small: 245 mm | ||||
| Small: 238 mm | ||||
| Medium: 233 mm | ||||
| Large: 240 mm | Similar | |||
| Dimensions - Width (Medium size) | ASTM D3578-19 | Min 95 +/- 10 mm (for medium size) | Overall: Min 95+/-10 mm (for medium size) | |
| X-Small: 77 mm | ||||
| Small: 81 mm | ||||
| Medium: 93 mm | ||||
| Large: 101 mm | Similar | |||
| Physical Properties - Tensile Strength | ASTM D3578-19 | Before Ageing: Tensile Strength > 18 MPa | ||
| After Ageing: Tensile Strength > 14 MPa | Before Ageing: Tensile Strength > 18 MPa | |||
| Actual values: X-Small: 29.6 MPa, Small: 25 MPa, Medium: 26 MPa, Large: 24.9 MPa | ||||
| After Ageing: Tensile Strength > 14 MPa | ||||
| Actual values: X-Small: 25.5 MPa, Small: 24.1 MPa, Medium: 22.2 MPa, Large: 24.4 MPa | Similar | |||
| Physical Properties - Ultimate Elongation | ASTM D3578-19 | Before Ageing: Ultimate Elongation > 650% | ||
| After Ageing: Ultimate Elongation > 500% | Before Ageing: Ultimate Elongation > 650% | |||
| Actual values: X-Small: 810%, Small: 760%, Medium: 680%, Large: 780% | ||||
| After Ageing: Ultimate Elongation > 500% | ||||
| Actual values: X-Small: 820%, Small: 760%, Medium: 650%, Large: 760% | Similar | |||
| Thickness | ASTM D3578-19 | Palm: > 0.08 mm | ||
| Finger: > 0.08 mm | Palm: > 0.08 mm | |||
| Actual values: X-Small: 0.102 mm, Small: 0.087 mm, Medium: 0.10 mm, Large: 0.108 mm | ||||
| Finger: > 0.08 mm | ||||
| Actual values: X-Small: 0.114 mm, Small: 0.109 mm, Medium: 0.122 mm, Large: 0.121 mm | Similar | |||
| Powder Free Residue | ASTM D3578-19 | $\leq$ 2 mg/glove | 0.68 mg/glove (for Medium) | Similar |
| Water Tight (1000 ml) | ASTM D5151-19 AQL-2.5 | Passes | Passes | Similar |
| Extractable Protein | ASTM D5712-15 | 200 µg/dm² Max | 187.1 µg/dm² (for Medium) | Meets criteria |
| Biocompatibility - Primary Skin Irritation | ISO 10993-10:2010(E) | Under the condition of study, not an irritant | Under the condition of study, not an irritant | Same |
| Biocompatibility - Dermal Sensitization | ISO 10993-10:2010(E) | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer | Same |
| Biocompatibility - In vitro Cytotoxicity | ISO 10993-5:2009(E) | Under the conditions of the study, non-cytotoxic | Under the conditions of the study cytotoxic for 100% (neat) test item extract. A follow-up acute systemic toxicity test demonstrated the extract did not present an acute systemic toxicity concern. | Meets criteria |
| Biocompatibility - Acute Systemic Toxicity | ISO 10993-11:2017(E) | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Same |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for length or tensile strength). However, the tests are conducted according to ASTM D3578-19, ASTM D5151-19, ASTM D6124-06, and ASTM D5712-15, which describe the standard test methods and typically include specifications for sampling.
The data provenance is from non-clinical bench testing and biocompatibility studies of the "Comfortpro" device. The manufacturer is THAI RUBBER INDUSTRY COMPANY LIMITED, located in Thailand. The tests are therefore likely performed by the manufacturer or a third-party lab on behalf of the manufacturer, and the data is prospective as it's generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (patient examination glove) does not involve a "ground truth" established by human experts in the typical sense of medical image analysis or diagnostic studies. The performance is assessed against established international consensus standards (ASTM and ISO) for physical properties and biocompatibility. The "ground truth" is not based on expert interpretation but on the quantitative measurement and qualitative assessment defined by these standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the performance is measured against objective standards, not subjective human assessment requiring adjudication.
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
Not applicable. This is not an AI-powered diagnostic device or a device where human interpretation is a primary performance factor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (glove), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is defined by international consensus standards (ASTM D3578-19, ASTM D5151-19, ASTM D6124-06, ASTM D5712-15, ISO 10993-10:2010(E), ISO 10993-5:2009(E), ISO 10993-11:2017(E)). These standards specify the test methods and the acceptable ranges for the physical and biological properties of the gloves.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. 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.