(239 days)
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM 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 product has been tested with chemotherapy drugs in accordance with ASTM D6978. The breakthrough detection times are as follows:
Test Chemotherapy Drug Name and Concentration Minimum Breakthrough Detection Time Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) ● 4.3 Minutes >240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
10.9 Minutes
240 Minutes
- Cisplatin(1.0mg/ml), (1,000 ppm)
- Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm)
- Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) ●
- Doxorubicin HCL(2mg/ml),(2,000 ppm)
- Etoposide /Toposar (20mg/ml), (20,000 ppm)
- Fluorouracil(50mg/ml), (50,000 ppm)
- Ifosfamide (50mg/ml), (50,000 ppm)
- Mitoxantrone(2mg/ml),(2,000 ppm)
- Paclitaxel(6.0mg/ml),(6,000 ppm)
- Thiotepa (10mg/ml),(10,000 ppm)
- . Vincristine Sulfate(1.0mg/ml),(1,000 ppm)
Please note that Carmustine and Thiotepa have extremely low permeation times of 4.3 minutes and 10.9 minutes, respectively.
Warning: Do not use with Carmustine and Thiotepa.
The subject device in this 510(k) Notification is Sterling/Grey coloured Nitrile Examination gloves, with claims and tested for use with Chemotherapy drugs.
The subject device is a patient examination glove made from nitrile compound, Sterling or Grey 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 meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
This device also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy drugs as per ASTM D6978-05
The provided text describes the acceptance criteria and the study that proves the BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM meets these criteria.
Here's the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Acceptance Criteria (Predicate Device K081089) | Reported Device Performance (Subject Device) | Result of Comparison |
|---|---|---|---|---|
| Labeling | N/A | No special labeling claims, no claim of hypoallergenic. | No special labeling claims, no claim of hypoallergenic. | Same |
| Device Materials | N/A | Nitrile Compound | Nitrile Compound | Same |
| Colour | N/A | Sterling | Sterling / Grey | Same |
| Tensile strength (Before and after ageing) | ASTM 6319-10 | > 14 MPa | > 14 MPa | Same |
| Ultimate Elongation (Before and after ageing) | ASTM 6319-10 | > 500 % | > 500 % | Same |
| Freedom from Pinholes | ASTM 6319-10 (FDA 1000 ml water leak test) | Pass | Pass | Same |
| Dimensions: Length | ASTM 6319-10 | > 295 mm | > 295 mm (295 mm minimum - 325 mm) | Same |
| Dimensions: Width | ASTM 6319-10 | 70±10 mm to 120±10 mm (sizes XS to XL) | 70±10 mm to 120±10 mm (sizes XS to XL) | Same |
| Dimensions: Thickness | ASTM 6319-10 | > 0.05 mm (palm & finger) | > 0.05 mm (Palm: 0.075mm-0.08mm; Finger: 0.085mm-0.10mm) | Same |
| Residual Powder | ASTM 6319-10 | Less than 2 mg per glove; PASS | Less than 2 mg per glove; PASS | Same |
| Primary Skin Irritation test | ISO 10993-10 | Under conditions of the study, not an irritant | Under conditions of the study, not an irritant | Same |
| Dermal sensitization assay | ISO 10993-10 | Under conditions of the study, not a sensitizer | Under conditions of the study, not a sensitizer | Same |
| Systemic Toxicity | ISO 10993-11 | Pass | Pass | Same |
| Chemical Permeation / Chemotherapy Testing (Breakthrough Detection Time) | ASTM D6978-05 | Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes | Carmustine: 4.3 Minutes; Cisplatin: >240 Minutes; Cyclophosphamide/Cytoxan: >240 Minutes; Dacarbazine: >240 Minutes; Doxorubicin HCL: >240 Minutes; Etoposide /Toposar: >240 Minutes; Fluorouracil: >240 Minutes; Ifosfamide: >240 Minutes; Mitoxantrone: >240 Minutes; Paclitaxel: >240 Minutes; Thiotepa: 10.9 Minutes; Vincristine Sulfate: >240 Minutes | Same (for Carmustine and Thiotepa, other drugs exceed the predicate's general criteria) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test mentioned (e.g., how many gloves were tested for pinholes, tensile strength, or chemotherapy permeation). It references standards like ASTM D6319-10 and ASTM D6978-05, which would have their own defined sample size requirements.
The data provenance is from Malaysia, as the submitter, BRIGHTWAY HOLDINGS SDN. BHD., is located in Klang, Selangor Darul Ehsan, Malaysia. The data appears to be prospective as it involves direct testing of the device against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The acceptance criteria and performance are based on recognized industry standards (ASTM, ISO), meaning the "ground truth" is defined by these standards rather than expert consensus on specific cases. The testing was performed according to these established protocols.
4. Adjudication method for the test set
This information is not applicable/not provided as the evaluation is based on objective measurements against predefined standards (ASTM, ISO) rather than subjective 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
This is not applicable. The device is an examination glove, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an examination glove, not an algorithm.
7. The type of ground truth used
The ground truth used is based on established industry standards and regulatory requirements. Specifically:
- Physical properties (tensile strength, elongation, dimensions, freedom from pinholes, residual powder) are compared against specifications in ASTM D6319-10.
- Biocompatibility (primary skin irritation, dermal sensitization, systemic toxicity) is evaluated against ISO 10993-10 and ISO 10993-11 requirements.
- Resistance to chemotherapy drug permeation is tested according to ASTM D6978-05.
- The overall criteria for patient examination gloves are also linked to FDA 21 CFR 880.6250.
8. The sample size for the training set
This is not applicable. The device is a physical product (gloves), not a machine learning model that requires a training set. The "training" in this context refers to the manufacturing process and quality control, not data training for an algorithm.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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.