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510(k) Data Aggregation
(103 days)
Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (no color is added) and are powder free.
The provided text describes the 510(k) summary for the "Latex Examination Powder Free Gloves" device (K202377). This document focuses on demonstrating substantial equivalence to a predicate device (K192329) based on non-clinical performance data, as it is a Class I medical device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study, ground truth establishment with experts, or similar clinical evaluation methods are not applicable here.
The "device" in this context is a pair of medical examination gloves, not an AI/software device. The "study" refers to non-clinical tests performed to demonstrate the physical and chemical properties of the gloves meet established standards.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for Latex Examination Powder Free Gloves (K202377)
The acceptance criteria for this device are established by adherence to recognized ASTM standards for rubber examination gloves. The study proving the device meets these criteria involves laboratory testing of various physical and chemical properties of the gloves.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard Applied (Acceptance Criteria) | Device Performance (Reported Result) | Meets Criteria? |
|---|---|---|---|
| Length | ASTM D3578-05 (Reapproved 2015): Min 230 mm for all sizes | X-Small: 303 mmSmall: 304 mmMedium: 304 mmLarge: 305 mm | Yes |
| Width | ASTM D3578-05 (Reapproved 2015):X-Small: 70+/-10 mmSmall: 80+/-10mmMedium: 95+/-10 mmLarge: 111+/-10 mm | X-Small: 75 mmSmall: 84 mmMedium: 94 mmLarge: 105 mm | Yes |
| Thickness | ASTM D3578-05 (Reapproved 2015):Palm: 0.08 mm minFinger: 0.08 mm min for all sizes | Palm: 0.16mm (all sizes)Finger: 0.21mm (all sizes) | Yes |
| Tensile Strength (Before Ageing) | ASTM D3578-05 (Reapproved 2015): 18 Mpa Min for all sizes | X-Small: 22.13 MpaSmall: 22.20 MpaMedium: 22.25 MpaLarge: 22.28 Mpa | Yes |
| Tensile Strength (After Ageing) | ASTM D3578-05 (Reapproved 2015): 14 Mpa Min for all sizes | X-Small: 18.57 MpaSmall: 18.64 MpaMedium: 18.70 MpaLarge: 18.74 Mpa | Yes |
| Ultimate Elongation (Before Ageing) | ASTM D3578-05 (Reapproved 2015): 650% Min for all sizes | X-Small: 867%Small: 871%Medium: 874%Large: 877% | Yes |
| Ultimate Elongation (After Ageing) | ASTM D3578-05 (Reapproved 2015): 500% Min for all sizes | X-Small: 845%Small: 848%Medium: 854%Large: 860% | Yes |
| Stress at 500% Elongation (Before Ageing) | ASTM D3578-05 (Reapproved 2015): 5.5 Mpa Max for all sizes | X-Small: 5.1 MpaSmall: 5.1 MpaMedium: 5.2 MpaLarge: 5.2 Mpa | Yes |
| Water Tightness (Holes) | ASTM D5151-06 (Reapproved 2015): AQL 2.5 | Passes AQL 1.5 | Yes |
| Residual Powder | ASTM D6124-06 (Reapproved 2017): 2 Mg/Glove Max | X-Small: 0.21 mg/gloveSmall: 0.21 mg/gloveMedium: 0.22 mg/gloveLarge: 0.22 mg/glove | Yes |
| Extractable Protein | ASTM D 5712-95 (Reapproved 2010): 200 µg/dm² Max for all sizes | X-Small: 50 µg/dm²Small: 50 µg/dm²Medium: 50 µg/dm² | Yes |
| Biocompatibility | ISO 10993-10:2010(E) (Primary Skin Irritation/Dermal Sensitization), ISO 10993-5:2009(E) (In vitro cytotoxicity), ISO 10993-11:2017(E)/USP 41<151> (Material mediated Pyrogenicity), USP 42<85> (Bacterial Endotoxin), ISO 10993-11:2017(E) (Acute Systemic Toxicity) | Not an irritant, not a sensitizer, non-cytotoxic, non-pyrogenic, <20EU/pair of gloves (for Bacterial Endotoxin), extracts do not pose systemic toxicity concern | Yes |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not explicitly state the numerical sample sizes for each test (e.g., how many gloves were tested for length, how many for tensile strength). However, it implies that samples were taken from different sizes (X-Small, Small, Medium, Large) to cover the range of the product.
- Data Provenance: The device manufacturer, Hi-Care Thai Gloves Co. Ltd., is listed with an address in Songkhla, Thailand. Therefore, the data originates from tests conducted on devices manufactured in Thailand. The testing is prospective in the sense that it's performed on the specific new device being submitted for clearance to demonstrate it meets pre-defined standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This question is not applicable to this type of medical device submission. The "ground truth" for medical gloves is not established by expert clinical consensus or medical judgment, but by objective, standardized laboratory tests according to ASTM and ISO specifications. The qualifications of the personnel performing these tests would be in laboratory science, quality assurance, and adherence to test protocols, not necessarily medical expertise or experience.
4. Adjudication Method for the Test Set:
- This is not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies, particularly for AI/reader performance evaluations, where there might be subjective interpretations or discrepancies among human readers. For physical and chemical tests of medical gloves, the results are quantitative and objective, directly compared against a numerical standard.
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 is not applicable. This submission is for a Class I physical medical device (gloves), not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study, human reader improvement metric, or AI assistance is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This is not applicable. Again, this is for a physical medical device, not an algorithm or AI. The "performance" is the glove's ability to meet predefined physical and chemical properties.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on established industry standards and regulatory requirements for physical and chemical properties as defined by the referenced ASTM and ISO standards. This is an objective, quantitative ground truth, as opposed to subjective clinical interpretations. For example, for "Length," the ground truth is "Min 230 mm," not an expert's opinion.
8. The Sample Size for the Training Set:
- This is not applicable. This is a physical product, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- This is not applicable as there is no training set for this device.
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