(104 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The gloves are powder free, ambidextrous with beaded-cuff, black colored, single-use disposable devices that come in six sizes (XS, S, M, L, XL, XXL), and supplied in Non-Sterile state.
The gloves are made of Nitrile Butadiene Rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Its physical and performance characteristics meet all requirements of ASTM D6319-10.
The provided document describes the acceptance criteria and performance of the Kossan International Sdn. Bhd. Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile (K143131). This is a medical device, and the "study" referred to is the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's the information extracted and organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standards Requirements) | Reported Device Performance (Results Summary) |
|---|---|---|
| Dimensions | ASTM D6319-10 (Length $\ge$ 230mm, Palm Thickness $\ge$ 0.05mm, Finger Thickness $\ge$ 0.05mm, Specific Width ranges for XS, S, M, L, XL, XXL) | Meets Standard Requirements (Explicit values not provided in summary, but stated agreement with standard) |
| Physical Properties | ASTM D6319-10 (Before Aging: Tensile Strength $\ge$ 14 MPA, Elongation $\ge$ 500%; After Aging: Tensile Strength $\ge$ 14 MPA, Elongation $\ge$ 400%) | Meets Standard Requirements (Explicit values not provided in summary, but stated agreement with standard) |
| Freedom from Pinholes | ASTM D5151-11, ASTM D6319-10 (Pass quality level at G1 AQL 1.5) | Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5. Meets Standard Requirements. |
| Powder Free Residue | ASTM D6124-11, ASTM D6319-10 (Values $\le$ 2 mg of residual powder per glove) | Result generated values $\le$ 2 mg of residual powder per glove. Meets Standard Requirements. |
| Biocompatibility | Dermal Sensitization (as ISO 10993-10:2010), Primary Skin Irritation Test (as ISO 10993-10:2010) | Dermal Sensitization: Magnusson & Kligman Scale is '0'. Device is not a sensitizer. Meets Standard Requirements. |
| Primary Skin Irritation: Primary Irritation Index for Erythema and Edema is '0'. Device is not an irritant. Meets Standard Requirements. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of gloves or animals/humans) used for each non-clinical test (dimensions, physical properties, pinholes, powder residue, biocompatibility). It only references adherence to ASTM and ISO standards, which would dictate appropriate sample sizes for each test.
- Data Provenance: The tests were conducted by Kossan International Sdn. Bhd. (Malaysia), making the data provenance likely from Malaysia. The data is non-clinical/laboratory test data, not patient data, so "retrospective or prospective" is not an applicable distinction in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for this device's performance is established by objective measurements against recognized industry standards (ASTM, ISO) in a laboratory setting, not by expert consensus on clinical findings. Therefore, no experts were used to establish a clinical ground truth for the test set in the traditional sense of medical image analysis or diagnostic studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess data (e.g., images), and discrepancies need to be resolved. For non-clinical, objective laboratory tests of physical properties and biocompatibility, the results are typically determined by measurements and observations according to established protocols, not by expert 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
No MRMC comparative effectiveness study was done. This document pertains to the regulatory clearance of a physical medical device (examination gloves) based on non-clinical performance and biocompatibility data. It does not involve AI or human readers for diagnostic assessment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This document is about a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" is based on objective laboratory measurements and tests against predefined industry standards (ASTM D6319-10, ASTM D5151-11, ASTM D6124-11, ISO 10993-10:2010 for biocompatibility). For example:
- Physical dimensions: measured values compared to specified ranges.
- Physical properties (tensile strength, elongation): measured values compared to minimum requirements.
- Freedom from pinholes: water leak test results compared to AQL.
- Powder free residue: measured weight of residual powder compared to maximum limit.
- Biocompatibility: animal study results (Magnusson & Kligman Scale, Primary Irritation Index) compared to "non-sensitizer" and "non-irritant" conclusions.
8. The sample size for the training set
This information is not applicable. This is not an AI/machine learning device. No training set was used.
9. How the ground truth for the training set was established
This information is not applicable. This is not an AI/machine learning device. No training set was used.
§ 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.