(123 days)
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [BLUE] is a disposable device intended for medical purpose to be worn on the examiners hand or finger to prevent contamination between the patient and the examiner.
The subject device in this 510(k) Notification is a Blue Examination Glove. The subject device is a patient examination glove made from a Nitrile compound, Blue 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.
The provided text describes the acceptance criteria and the study conducted for the Brightway Nitrile Examination Glove, powder-free (blue).
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally based on the ASTM D6319-10 standard for Nitrile Examination Gloves. The device performance is reported as meeting these specifications.
| Characteristic | Acceptance Criteria (Standard / Description) | Reported Device Performance |
|---|---|---|
| Dimension Measurement | ASTM D6319-10 (Specific ranges for weight, length, width, thickness by size) | All samples passed all dimension measurements. No non-conformance reported. |
| Water-tightness (Freedom from Pinholes) | ASTM D5151-06; G2 AQL 1.0, Ac=5 Rej=6 | 1 total defective found across all sizes (in one sample's palm). Acceptance number is 5. Status: Pass. |
| Tensile Strength (Before Aging) | ASTM D6319-10: 14 MPa (Min) | Average Result: 24.351 MPa. Status: Pass. |
| Ultimate Elongation (Before Aging) | ASTM D6319-10: 500% (Min) | Average Result: 550.6%. Status: Pass. |
| Tensile Strength (After Aging) | ASTM D6319-10: 14 MPa (Min) | Average Result: 22.134 MPa. Status: Pass. |
| Ultimate Elongation (After Aging) | ASTM D6319-10: 400% (Min) | Average Result: 484.5%. Status: Pass. |
| Labeling | No special labeling claims or claims of gloves as hypoallergenic. | No special labeling claims or claims of gloves as hypoallergenic. |
| Device Materials | Nitrile Compound | Nitrile Compound |
| Indications for Use | Intended for medical purpose, to be worn on examiners hand or finger to prevent contamination between patient and examiner. | Intended for medical purpose, to be worn on examiners hand or finger to prevent contamination between patient and examiner. |
| Color | Blue | Blue |
| Length | ASTM D6319-10: > 230 mm | > 230 mm (230-258mm) |
| Width | ASTM D6319-10: 70±10 mm to 120±10 mm (sizes XS to XL) | 70±10 mm to 120±10 mm (sizes XS to XL) |
| Thickness | ASTM D6319-10: > 0.05 mm (palm & finger) | > 0.05 mm (Palm: 0.08mm-0.16mm; Finger: 0.12mm-0.19mm) |
| Residual Powder | ASTM D6319-10, ASTM D6124: Less than 2 mg per glove | Less than 2 mg per glove. Status: Pass. |
| Primary Skin Irritation test | ISO 10993-10: Not an irritant | Under conditions of the study, not an irritant. |
| Dermal Sensitization Assay | ISO 10993-10: Not a sensitizer | Under conditions of the study, not a sensitizer. |
| Systemic Toxicity | ISO 10993-10: No systemic toxicity revealed | Under conditions of study, did not reveal any systemic toxicity. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Dimension Measurement: 20 pieces per batch. Random Sampling based on ISO2859-1:1999; S2 AQL 2.5, Ac=1 Rej=2. Data provided is for Batch No: 6H10 03.
- Water-tight Test (Freedom from Holes): 200 pieces per batch. Random Sampling based on ISO2859-1:1999; G2 AQL 1.0, Ac=5 Rej=6.
- Physical Properties (Tensile Strength, Ultimate Elongation): 20 samples (1 sample for each size XS, S, M, L, XL x 4 replicates per size, but the table shows 20 distinct samples with sizes varying, suggesting 4 per size covering XS-XL). Sampling Plan: Single Normal S2 AQL: 2.5 Acc/Rej: 1/2.
- Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Systemic Toxicity): Specific sample sizes are not explicitly stated for these tests within the provided document, but the tests were performed "under the conditions of the studies."
- Data Provenance: The tests were conducted by Brightway Holdings Sdn Bhd, which is based in Malaysia. The testing certificates are dated August 22, 2016, and the overall submission is dated March 24, 2017. This indicates the studies were conducted prior to the submission, likely as part of the device development and verification, making them retrospective in the context of this submission.
3. 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 device is a patient examination glove. The "ground truth" for its performance is established by adherence to recognized industry standards (like ASTM D6319-10, ASTM D5151-06, ISO 10993-10). These standards define objective, measurable physical, chemical, and biological properties. Therefore, no human experts (like radiologists) are typically involved in establishing a "ground truth" for the physical and biological characteristics of a glove. The "ground truth" is the quantitative measurement against the standard specification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since the assessment relies on objective measurements against predefined standards (e.g., tensile strength, dimensions, water leak test), there is no adjudication method described or required by human experts. The results are quantitative and directly compared to the specified limits.
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, an MRMC comparative effectiveness study was not done. This device is a physical medical device (examination glove), not an AI-powered diagnostic tool, and therefore, an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical examination glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective measurements and laboratory test results compared against established international and national standards for medical gloves. This includes:
- Physical properties (e.g., length, width, thickness, weight, tensile strength, ultimate elongation)
- Barrier integrity (e.g., freedom from pinholes via water leak test)
- Chemical properties (e.g., residual powder)
- Biocompatibility (e.g., primary skin irritation, dermal sensitization, systemic toxicity).
8. The sample size for the training set
Not applicable. This device is a physical medical device (examination glove), not a machine learning model, and therefore does not have a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
Not applicable. As stated above, this device does not use a training set.
§ 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.