(157 days)
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER] is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is a Lavender Examination Glove. The subject device is a patient examination glove made from a Nitrile compound, Lavender in colour, powder free and non sterile (as per 21 CFR 880.6250, class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device that meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10 ; Standard specification for Nitrile Examination Gloves.
Here's a breakdown of the acceptance criteria and study information for the Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender), based on the provided document:
Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Standard) | Reported Device Performance | Result |
|---|---|---|---|
| Dimension and Thickness | |||
| Weight (for each size XS-XL) | $Range around target (e.g., XS: $2.7 \pm 0.3g$) | All samples within specification | Pass |
| Length (Min-Max) | Min - 230mm, Tar - 240mm, Max - 258mm | All samples within specification | Pass |
| Width (Min-Max for each size XS-XL) | Range around target | All samples within specification | Pass |
| Finger Tip Thickness (Min-Max) | Min - 0.06mm, Tar - 0.08mm, Max - 0.11mm | All samples within specification | Pass |
| Palm Thickness (Min-Max) | Min - 0.05mm, Tar - 0.07mm, Max - 0.09mm | All samples within specification | Pass |
| Cuff Thickness (Min-Max) | Min - 0.05mm, Tar - 0.06mm, Max - 0.08mm | All samples within specification | Pass |
| Freedom from Holes | ASTM D5151; AQL 1.5, Ac=7 Rej=8 for 200 pcs | 1 defective found | Pass |
| Physical Properties (Before Aging) | |||
| Tensile Strength (MPa) | 16 (Min) [ASTM D 6319-10] | 27.805 (Avg.) | Pass |
| Ultimate Elongation (%) | 500 (Min) [ASTM D 6319-10] | 588.8 (Avg.) | Pass |
| Physical Properties (After Aging) | |||
| Tensile Strength (MPa) | 15 (Min) [ASTM D 6319-10] | 26.075 (Avg.) | Pass |
| Ultimate Elongation (%) | 450 (Min) [ASTM D 6319-10] | 523.5 (Avg.) | Pass |
| Biocompatibility | |||
| Primary Skin Irritation test | ISO 10993-10: Not an irritant | Not an irritant | Pass |
| Dermal Sensitization assay | ISO 10993-10: Not a contact sensitizer | Not a contact sensitizer | Pass |
| Systemic Toxicity | ISO 10993-11: Non-systemically toxic | Non-systemically toxic | Pass |
| Residual Powder | ASTM D6124: Meets requirements | Meets requirements | Pass |
Study Information
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Sample size used for the test set and the data provenance:
- Dimension Measurement: 20 pieces per batch. Random Sampling based on ISO2859-1:1999; S2 AQL 2.5, Ac=1 Rej=2.
- Water-tight Test: 200 pieces per batch. Random Sampling based on ISO2859-1:1999; G2 AQL 1.5, Ac=7 Rej=8.
- Physical Properties Analysis: Not explicitly stated but "Single Normal S2 AQL: 2.5 Acc/Rej : 1/2" for sampling plan. Given that 20 samples were tested and individual results are shown, it seems 20 samples were used for the physical properties test.
- Biocompatibility Studies (Primary Skin Irritation, Dermal Sensitization, Systemic Toxicity): Sample sizes for these tests are not provided in the document.
- Data Provenance: The tests were conducted by Brightway Holdings Sdn Bhd (the manufacturer) in Malaysia. The document does not specify if the data is retrospective or prospective, but as it's part of a 510(k) submission for a new device, it would typically involve prospective testing of newly manufactured devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not applicable to the device described. The "ground truth" for examination gloves is established by standardized physical and chemical testing methods (ASTM, ISO), not by expert consensus or interpretations.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Performance is measured against objective standards, not subjective interpretations requiring adjudication.
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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 device is an examination glove, not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an examination glove, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on objective, standardized measurements and tests outlined in recognized standards such as ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves), ASTM D5151 (Water Leak Test), ASTM D6124 (Residual Powder), and ISO 10993 (Biocompatibility).
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The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This device is not an AI/machine learning model.
§ 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.