(236 days)
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY 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
- · Carmustine (BCNU) (3.3mg/ml),(3.300 ppm)
- · 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/Taxol(6.0mg/ml),(6.000 ppm)
- · Thiotepa (10mg/ml),(10,000 ppm)
- · Vincristine Sulfate(1.0mg/ml),(1,000 ppm)
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) 5.4 minutes and Thiotepa 40.4 minutes.
Minimum Breakthrough Detection Time
5.4 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
40.4 Minutes
240 Minutes
The subject device in this 510(k) Notification is a Sterling/Grey 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 Grev 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 is manufactured in facilities compliant to ISO 9001:2008 certified in Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination, Surgical and Industrial Gloves & Nitrile Sheath
The device is manufactured to comply with ISO 13485:2003 / EN ISO 13485:2012 Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination & Sterile Surgical Gloves
This document describes the premarket notification (510(k)) for "BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS". The acceptance criteria and the study proving the device meets these criteria are outlined through a comparison with a legally marketed predicate device (K151750).
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Test | Acceptance Criteria (Predicate K151750 and general standards) | Reported Device Performance (Subject Device K161215) | Comments / Proof of Meeting Criteria |
|---|---|---|---|
| General | |||
| Device Type | Patient Examination Glove (21 CFR 880.6250) | Nitrile Examination Gloves, Powder Free | Same |
| Intended Use | Prevent contamination between patient and examiner. Tested for use with chemotherapy drugs. | Prevent contamination between patient and examiner. Tested for use with chemotherapy drugs. | Same |
| Material | Nitrile | Nitrile | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Single Use | Yes | Yes | Same |
| Design | Meet Requirements of ASTM D6319 | Meet Requirements of ASTM D6319 | Same (Implied by standard compliance) |
| Physical Properties | Meets Requirements of ASTM D6319 | Meets Requirements of ASTM D6319 | Same |
| Dimensions | |||
| Length | min 230 mm / ≥ 230mm, Meets Requirements of ASTM D6319 | minimum 230 mm, target 242 mm, maximum 258 mm, Meets Requirements of ASTM D6319 | Same |
| Thickness (Cuff) | 0.032-0.050 mm | 0.05-0.07 mm | Meets requirements of ASTM D6319. (While the ranges differ, both are stated to meet the standard, indicating the subject device's range is within acceptable limits of the standard.) |
| Thickness (Palm) | 0.055-0.085 mm | 0.06-0.09 mm | Meets requirements of ASTM D6319. |
| Thickness (Finger) | 0.065-0.095 mm | 0.07-0.10 mm | Meets requirements of ASTM D6319. |
| Performance - Barrier | |||
| Powder Free Residue | ≤ 2mg/glove | ≤ 2mg/glove | Same |
| Freedom from pinholes testing | Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5 | Tested in accordance with ASTM D5151 test method. Pass quality level at G2 AQL 1.0 | Subject device tested to a more stringent criteria of G2 AQL 1.0 |
| Performance - Chemotherapy Drug Permeation | (Based on predicate performance and "above 30 minutes permeation time" criteria for some drugs) | ||
| Carmustine (BCNU) (3.3mg/ml) | 10.1 minutes (Predicate) / "Below 30 minutes permeation time" | 5.4 minutes | Below 30 minutes permeation time, same as the predicate device. A warning statement is included. |
| Cisplatin (1.0mg/ml) | >240 minutes | >240 minutes | Same |
| Cyclophosphamide/Cytoxan (20mg/ml) | >240 minutes | >240 minutes | Same |
| Dacarbazine (DTIC) 10mg/ml | >240 minutes | >240 minutes | Same |
| Doxorubicin HCL (2mg/ml) | >240 minutes | >240 minutes | Same |
| Etoposide /Toposar (20mg/ml) | Not explicitly listed for predicate, assumed >240 as per other drugs | >240 minutes | Implicitly meets, with similar performance to most other listed drugs. |
| Fluorouracil (50mg/ml) | >240 minutes | >240 minutes | Same |
| Ifosfamide (50mg/ml) | >240 minutes | >240 minutes | Same |
| Mitoxantrone (2mg/ml) | >240 minutes | >240 minutes | Same |
| Paclitaxel/Taxol (6.0mg/ml) | >240 minutes | >240 minutes | Same |
| Thiotepa (10mg/ml) | 30.2 minutes (Blue Predicate), 10.4 minutes (White Predicate) | 40.4 minutes | Subject device had a permeation time of 40.4 mins which exceeded 30 mins, but less than 60 mins. A warning statement is included. |
| Vincristine Sulfate (1.0mg/ml) | >240 minutes | >240 minutes | Same |
| Biocompatibility | |||
| Dermal Sensitization (ISO 10993-10:2010) | Not a contact sensitizer under the conditions of the study | Not a contact sensitizer under the conditions of the study | Same |
| Primary Skin Irritation Test (ISO 10993-10:2010) | Not a primary skin irritant under the conditions of the study | Not a primary skin irritant under the conditions of the study | Same |
| Systemic Toxicity (ISO 10993-11) | (Predicate not tested) | No mortality or no evidence of Systemic Toxicity was observed | Predicate device was not tested for Systemic Toxicity. Subject device was tested for Acute Systemic Toxicity and no mortality or evidence of Systemic Toxicity was observed. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for the various tests (e.g., pinhole, chemotherapy permeation, physical properties, biocompatibility). It references standardized test methods (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010, 16 CFR Part 1500.41) which typically define appropriate sample sizes. The data provenance is non-clinical performance data, likely generated prospectively by the manufacturer and/or a testing laboratory contracted by the manufacturer. The country of origin of the data is not specified beyond the manufacturer being based in Malaysia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The device is a patient examination glove, and its performance is evaluated against objective, standardized physical, chemical, and biological tests, not against expert interpretation of medical images or other diagnostic data where ground truth would be established by human experts.
4. Adjudication method for the test set
This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, often in clinical trials or comparative imaging studies. The testing described here is based on objective, standardized laboratory methods.
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 section is not applicable. MRMC studies and the concept of AI assistance for human readers are relevant for diagnostic devices (e.g., AI for radiology interpretation). The device in question is a medical glove, for which such a study design is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance claims of this device is established through:
- Standardized Test Methods and Specifications: Adherence to ASTM D6319-10 (Standard specification for Nitrile Examination Gloves), ASTM D5151-06 (standard for pinholes), ASTM D6124-06 (standard for powder residue), ISO 10993-10:2010 (biocompatibility - irritation and sensitization), ISO 10993-11 (biocompatibility - systemic toxicity), and 16 CFR Part 1500.41 (flammability).
- Predicate Device Performance: The performance of the legally marketed predicate device (K151750) serves as a benchmark for substantial equivalence, particularly concerning chemotherapy drug permeation.
8. The sample size for the training set
This section is not applicable. A "training set" refers to data used to train machine learning models. This device is a physical product and does not involve AI or machine learning algorithms.
9. How the ground truth for the training set was established
This section is not applicable for the reasons stated in 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.