(249 days)
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS 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 tested chemotherapy drugs and their breakthrough detection times are as follows:
• Arsenic Trioxide (0.1mg/ml),(100ppm) >240 Minutes
• Bleomycin Sulfate (15mg/ml),(15,000 ppm) >240 Minutes
• Busulfan(6mg/ml),(6,000 ppm) >240 Minutes
• Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) 127.5 Minutes
• Cisplatin (1.0mg/ml), (1,000 ppm) >240 Minutes
• Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm) >240 Minutes
• Cytarabine(100mg/ml), (100,000 ppm) >240 Minutes
• Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) >240 Minutes
• Daunorubicin(5mg/ml), (5,000 ppm) >240 Minutes
• Docetaxel(10mg/ml), (10,000 ppm) >240 Minutes
• Doxorubicin HCL(2mg/ml),(2,000 ppm) >240 Minutes
• Ellence (2mg/ml), (2,000 ppm) >240 Minutes
• Etoposide /Toposar (20mg/ml), (20,000 ppm) >240 Minutes
• Fludarabine (25mg/ml), (25,000 ppm) >240 Minutes
• Fluorouracil(50mg/ml), (50,000 ppm) >240 Minutes
• Gemcitabine/Gemzar (38mg/ml), (38,000 ppm) >240 Minutes
• Idarubicin (1.0mg/ml), (1,000 ppm) >240 Minutes
• Ifosfamide (50mg/ml), (50,000 ppm) >240 Minutes
• Irinotecan(20mg/ml), (20,000 ppm) >240 Minutes
• Mechlorethamine HCI(1.0mg/ml), (1,000 ppm) >240 Minutes
• Melphalan(5mg/ml), (5,000 ppm) >240 Minutes
• Methotrexate(25mg/ml),(25,000 ppm) >240 Minutes
• Mitomycin C(0.5 mg/ml), (500 ppm) >240 Minutes
• Mitoxantrone(2mg/ml),(2,000 ppm) >240 Minutes
• Paclitaxel(6.0mg/ml),(6,000 ppm) >240 Minutes
• Paraplatin (10mg/ml),(10,000 ppm) >240 Minutes
• Rituximab(10mg/ml),(10,000 ppm) >240 Minutes
• Thiotepa (10mg/ml),(10,000 ppm) >240 Minutes
• Trisenox(0.1mg/ml), (100 ppm) >240 Minutes
• Vincristine Sulfate(1.0mg/ml).(1.000 ppm) >240 Minutes
Please note that the following drug noted permeation times below 240 mins: Carmustine (BCNU) 127.50 mins.
The subject device in this 510(k) Notification is a Purple Nitrile Examination gloves, tested for use with Chemotherapy drugs.
The subject device is a patient examination glove made from nitrile compound, Purple in color, 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
This document describes the premarket notification (510(k)) for BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS, seeking to prove substantial equivalence to a predicate device. The "acceptance criteria" here refers to the performance standards and regulatory requirements that the device must meet to be considered substantially equivalent to a legally marketed predicate device, rather than specific AI/ML performance metrics. Similarly, the "study" proving the device meets these criteria refers to the non-clinical testing performed on the gloves.
Given the nature of the device (examination gloves), the concepts of "AI assistance," "human observers," "training set," and "ground truth" (in the context of expert consensus or pathology for medical images/diagnoses) are not applicable. The "study" here is a series of non-clinical, laboratory-based tests to demonstrate the physical properties, biocompatibility, and chemical permeation resistance of the gloves.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by recognized industry standards (ASTM, ISO) and FDA regulations. The reported device performance is the outcome of testing against these standards.
Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Standard | Acceptance Criteria (from Standard) | Reported Device Performance (Subject Device) | Result of Comparison |
|---|---|---|---|
| Labeling | No special labeling claims, no hypoanergic claims | No special labeling claims, no hypoanergic claims | Same |
| Device Materials | Nitrile Compound | Nitrile Compound | Same |
| Colour | Purple | Purple | 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 1000ml water leak test) | Pass | Pass | Same |
| Length (ASTM 6319-10) | > 295 mm (for 12" glove) | > 295 mm (295 mm minimum - 325 mm) | Same |
| 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 |
| Thickness (ASTM 6319-10) | > 0.05 mm (Palm 0.12mm Finger : 0.15mm) | > 0.05 mm (Palm :0.14mm-0.18mm Finger : 0.20mm-0.24mm) | Same |
| Residual Powder (ASTM D6124) | 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 |
| Acute Systemic Toxicity (ISO 10993-11) | Under conditions of the study, device does not induce acute systemic toxicity | Under conditions of the study, device does not induce acute systemic toxicity | Same |
| Chemotherapy Drug Permeation (ASTM D6978-05) | |||
| - Arsenic Trioxide (0.1mg/ml) | (No specific predicate value provided for comparison) | > 240 Minutes | N/A (Predicate not tested, Subject Device passed) |
| - Bleomycin Sulfate (15mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Busulfan (6mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Carmustine (BCNU) (3.3mg/ml) | 30.7 Minutes (Predicate) | 127.5 Minutes | Subject device showed significantly longer breakthrough time. |
| - Cisplatin (1.0mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Cyclophosphamide/Cytoxan (20mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Cytarabine (100mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Dacarbazine (DTIC) (10mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Daunorubicin (5mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Docetaxel (10mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Doxorubicin HCL (2mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Ellence (2mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Etoposide /Toposar (20mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Fludarabine (25mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Fluorouracil (50mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Gemcitabine/Gemzar (38mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Idarubicin (1.0mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Ifosfamide (50mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Irinotecan (20mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Mechlorethamine HCl (1.0mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Melphalan (5mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Methotrexate (25mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Mitomycin C (0.5 mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Mitoxantrone (2mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Paclitaxel (6.0mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Paraplatin (Carboplatin) (10mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Rituximab (10mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Thiotepa (10mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Trisenox (0.1mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Vincristine Sulfate (1.0mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| Warning Statement (ASTM D6978-05) | Acknowledge drugs with low permeation times | Acknowledge Carmustine (BCNU) 127.50 mins permeation time | Same (Both predicate and subject device have warning statements for specific drugs, though the specific drug and time differ due to varied performance) |
Study Information (Non-Clinical Testing for Gloves)
Since this is a filing for medical examination gloves, the concepts below regarding AI/ML studies are not directly applicable. However, I will interpret them in the context of the testing performed on these physical devices.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not explicitly state the number of gloves tested for each characteristic (e.g., how many gloves were tested for pinholes, or how many samples for tensile strength). The standards referenced (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010, ASTM D6978-05) would specify the required sample sizes for each test.
- Data Provenance: The testing was performed according to international harmonized standards (ASTM, ISO). The manufacturer is Brightway Holdings Sdn Bhd. from Malaysia (Lot 1559, Jalan Istimewa, Batu Belah Klang, Selangor, 42100 MY). The data is implicitly prospective, as it was generated specifically for this 510(k) submission.
-
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):
- Not applicable in the AI/ML context. For physical device testing, the "ground truth" is established by the test methods themselves, defined by standards organizations (ASTM, ISO). The "experts" would be the certified laboratory technicians and engineers who perform the tests according to the standard operating procedures and interpret the results against the specified criteria. Their qualifications would be in laboratory science, materials testing, and adherence to quality systems.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable in the AI/ML context. For physical device testing, results are typically quantitative measurements or pass/fail determinations based on predefined criteria in the standards. Discrepancies would be resolved through re-testing or investigation into the test methodology, not through human consensus or adjudication of interpretations.
-
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 is a physical medical device (examination glove), not an AI/ML diagnostic or assistive tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" is based on standardized test methods and predefined quantitative/qualitative thresholds set by organizations like ASTM and ISO. For example, for "Freedom from Pinholes," the ground truth is a "Pass" or "Fail" based on a specified water leak test (FDA 1000ml water leak test) as incorporated into ASTM 6319-10. For chemotherapy permeation, the ground truth is the "breakthrough detection time" measured in minutes. Biocompatibility tests rely on established in-vitro and in-vivo assays with pass/fail criteria for irritation, sensitization, and toxicity.
-
The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML model that requires a training set. The manufacturing process is consistent, and quality control ensures consistency, but there isn't a "training set" in the AI sense.
-
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.
§ 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.