(129 days)
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a disposable device intended for medical purpose 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 :
| Test Chemotherapy Drug Name and Concentration | Minimum Breakthrough Detection Time |
|---|---|
| · Blenoxane (15mg/ml),(15,000 ppm) | >240 Minutes |
| · Busulfan(6mg/ml),(6,000 ppm) | >240 Minutes |
| · Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) | 3.6 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 (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) | 15.9 Minutes |
| · Trisenox(0.1mg/ml), (100 ppm) | >240 Minutes |
| · Vincristine Sulfate(1.0mg/ml),(1,000 ppm) | >240 Minutes |
Please note that Carmustine and Thiotepa have extremely low permeation times of 3,6 minutes, respectively
WARNING: Do Not Use With : Carmustine, ThioTEPA
The subject device in this 510(k) Notification is a Purple Nitrile Examination glove tested for use with Chemotherapy drugs.
The subject device is a patient examination glove made from nitrile compound, Purple 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.
The provided document pertains to a 510(k) premarket notification for "BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS." This is a Class I medical device, and the submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K992162 Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim).
The document does not describe an AI/ML-based device or a study involving human readers and AI assistance for medical image analysis. Instead, it details the physical and chemical properties of examination gloves, their resistance to chemotherapy drugs, and their biocompatibility, as per standard testing protocols for such devices.
Therefore, many of the requested elements for an AI/ML device study (e.g., sample size for AI test and training sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, AI effect size) are not applicable to this document.
However, I can extract the acceptance criteria and performance data relevant to this specific device (examination gloves):
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards as outlined in the document, and demonstrating performance comparable to the predicate device. The reported performance indicates compliance with these standards.
| Device Characteristics | Test Standard | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|---|
| Product: Nitrile Examination Gloves, Powder Free (Purple) Tested For Use with Chemotherapy Drugs | |||
| Primary Function: Barrier protection to prevent contamination between patient and examiner. Tested for resistance to permeation by chemotherapy drugs. | |||
| Chemical Permeation: | ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs) | Minimum breakthrough detection times for various chemotherapy drugs, typically >240 minutes for most tested drugs. Special note for drugs with low permeation times. | Met or exceeded >240 minutes for most tested drugs. Carmustine (3.3mg/ml): 3.6 minutes; Thiotepa (10mg/ml): 15.9 minutes. (These values are declared and warned against, indicating they meet the disclosure requirement but are below the general >240 min goal, hence the warning). The device meets the requirement by truthfully reporting its performance for each chemical. |
| Physical Attributes (General): | ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves) | Compliance with all requirements in ASTM D6319-10, including dimensions, physical properties (tensile strength, elongation). | Complies with ASTM D6319-10 both before and after accelerated aging. All sizes comply with length, width, and thickness dimensions. |
| Freedom from Holes: | ASTM D6319-10 by D5151-06 | Must meet specified AQL (Acceptable Quality Level) for freedom from holes. | Pass (Implies meeting or exceeding the AQL). |
| Powder Free Designation: | ASTM D6319-10 by D6124-06 | Less than 2.0 mg powder per glove. | Less than 2.0 mg per glove; Pass. |
| Biocompatibility: | ISO 10993-10:2010 (Reapproved 2014) | Not a skin irritant; Not a skin sensitizer. | Under conditions of the test, not a skin irritant; Under conditions of the test, not a skin sensitizer. |
| ISO 10993-11:2006 (Reapproved 2010) | Does not cause systemic toxicity. | Under conditions of the test, does not cause systemic toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific number of gloves (sample size) for each particular test. However, it references standards like ASTM D6319-10 and ISO 2859 (Sampling Procedures and Tables for Inspection by Attributes), which would dictate the appropriate sample sizes for the various tests (e.g., tensile strength, dimensions, pinholes, chemotherapy drug permeation). For example, ASTM D6978-05 for chemotherapy drug permeation typically involves testing a specified number of samples (often 3 replicates) per drug, which are then averaged or used to determine breakthrough time.
- Data Provenance: The testing was "non-clinical performance data" (Section 7). The manufacturing company, Brightway Holdings Sdn. Bhd., is located in Malaysia (Section 3). The testing was conducted according to international standards (ASTM, ISO), meaning the data provenance is from laboratory tests, not from human retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a physical device being tested against established ASTM and ISO standards in a laboratory setting. There is no concept of "ground truth" derived from human expert interpretation (like medical images) for this type of product. The "ground truth" is defined by the objective measurements and protocols outlined in the referenced standards.
4. Adjudication Method for the Test Set
- Not Applicable. As this involves laboratory testing against objective standards (e.g., measuring breakthrough time, tensile strength), there is no human adjudication process involved in establishing "ground truth" or test results in the way it would be for interpreting medical images. The measurements are taken by lab technicians and reported against the standard's pass/fail criteria or quantitative thresholds.
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
- Not Applicable. This document is for examination gloves, not an AI/ML device. Therefore, no MRMC study with human readers or AI assistance was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is for examination gloves, not an AI/ML algorithm.
7. The Type of Ground Truth Used
- Ground Truth: The "ground truth" for this device is defined by objective, standardized measurements and laboratory test results as per recognized ASTM and ISO international standards.
- For chemotherapy drug permeation: Breakthrough time measured according to ASTM D6978-05.
- For physical properties (tensile strength, elongation, dimensions, holes): Measured according to ASTM D6319-10 and its referenced sub-standards (e.g., ASTM D412, D5151).
- For biocompatibility: Biological responses (irritation, sensitization, systemic toxicity) measured according to ISO 10993-10 and ISO 10993-11.
8. The Sample Size for the Training Set
- Not Applicable. As this is not an AI/ML device, there are no training sets in the context of machine learning. The "training" for manufacturing occurs through process control and quality management systems to ensure consistent product performance.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. No AI/ML training set is involved.
§ 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.