(82 days)
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green) is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. Tested for use chemotherapy drugs. Tested drugs are as follows:
| Average Breakthrough Detection Time (minutes) | |
|---|---|
| Cisplatin 1.0 mg/ml | ≥ 240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | ≥ 240 |
| Dacarbazine (DTIC) 10.0 mg/ml | ≥ 240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | ≥ 240 |
| Etoposide (Toposar) 20.0 mg/ml | ≥ 240 |
| Fluorouracil 50.0 mg/ml | ≥ 240 |
| Paclitaxel (Taxol) 6.0 mg/ml | ≥ 240 |
Please note that the following drugs have extremely low permeation time for
*Carmustine (BCNU) 3.3mg.ml - 23.4 (mins)
*Thiotepa 10.0 mg/ml - 16.2 (mins)
The proposed device is the Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green). The proposed device is for single use and is provided non-sterile. The device meets the requirements for dimensions, physical properties, and thickness in ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application. The device accomplishes its intended function by creating a physical barrier between the examiner and patient and creates a barrier for the chemotherapy drugs listed in the Indications for Use.
This document is a 510(k) Premarket Notification for Powder Free Nitrile Examination Gloves tested for use with chemotherapy drugs. It focuses on demonstrating substantial equivalence to a legally marketed predicate device.
Here's the information extracted and organized according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance (New Device - K180476) | Comparison |
|---|---|---|---|
| Chemotherapy Drugs Permeation (Minimum Breakthrough Detection Time) | ASTM D6978-05 | ||
| Cisplatin 1.0 mg/ml | N/A (Comparative to predicate) | >240 minutes | Similar to predicate |
| Cyclophosphamide (Cytoxan) 20 mg/ml | N/A (Comparative to predicate) | >240 minutes | Similar to predicate |
| Dacarbazine (DTIC) 10.0 mg/ml | N/A (Comparative to predicate) | >240 minutes | Similar to predicate |
| Doxorubicin Hydrochloride 2.0 mg/ml | N/A (Comparative to predicate) | >240 minutes | Similar to predicate |
| Etoposide (Toposar) 20.0 mg/ml | N/A (Comparative to predicate) | >240 minutes | Similar to predicate |
| Fluorouracil 50.0 mg/ml | N/A (Comparative to predicate) | >240 minutes | Similar to predicate |
| Paclitaxel (Taxol) 6.0 mg/ml | N/A (Comparative to predicate) | >240 minutes | Similar to predicate |
| *Carmustine (BCNU) 3.3 mg/ml | N/A (Comparative to predicate, with warning) | 23.4 minutes | Similar to predicate, with warning |
| *Thiotepa 10.0 mg/ml | N/A (Comparative to predicate, with warning) | 16.2 minutes | Similar to predicate, with warning |
| Dimensions | ASTM D6319 - 10(2015) | Length - Min 240mm; Thickness palm and finger - Min 0.05mm | Same |
| Physical Properties | ASTM D6319 - 10(2015) | Meets | Same |
| Thickness (Finger & Palm) | ASTM D6319 - 10(2015) | Meets | Same |
| Powder Content | ASTM D6124 - 06(2011) (≤ 2 mg/glove) | Meets | Same |
| Biocompatibility: Primary Skin Irritation | ISO 10993-10:2010 | Passes (non-irritating) | Same |
| Biocompatibility: Dermal Sensitization | ISO 10993-10:2010 | Passes (non-sensitization) | Same |
| Biocompatibility: Cytotoxicity and acute systemic toxicity | ISO 10993-5:2009 & ISO 10993-5:2017 | Passes (Certificate of Analysis for color imparting compound indicates non-cytotoxic, not systemically toxic) | Different (Predicate N/A for this test) |
| Watertight (1000ml) | 21 CFR 800.20, ASTM D5151 | Passes | Same |
| Indication for Use | N/A (Comparative to predicate) | Specialty medical glove for medical purpose, worn on examiner's hand/finger to prevent contamination between examiner and patient, and to protect against exposure to listed chemotherapy drugs. | Similar |
| Material | ASTM D6319 - 10(2015) | Nitrile | Same |
| Color | N/A | Green | Different (Predicate: Blue or White) |
| Size | Medical Glove Guidance Manual - Labeling | Extra Small, Small, Medium, Large, Extra Large | Same |
| Single Use | Medical Glove Guidance Manual - Labeling | Single Use | Same |
The acceptance criterion for the chemotherapy drug permeation test appears to be established by comparison to the predicate devices. For most drugs, the criterion is a minimum breakthrough detection time of ">240 minutes". For Carmustine and Thiotepa, the low permeation times observed for both the new device and the predicate lead to a warning statement, indicating that these drugs have "extremely low permeation times" and are not held to the ">240 minutes" criterion.
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size used for the test set for properties like chemotherapy drug permeation, physical properties, or biocompatibility. It only reports "meets" or specific breakthrough times, implying that tests were conducted according to relevant standards (e.g., ASTM D6978-05 for chemotherapy drug permeation and ASTM D6319-10(2015) for physical properties and dimensions). These standards typically define sampling plans.
- Data Provenance: The manufacturer is Comfort Rubber Gloves Industries Sdn. Bhd., located in Matang, Perak, Malaysia. The document does not specify if the testing was performed in Malaysia or another country. The data is non-clinical performance data, likely from prospective testing conducted to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the device is a medical glove, and its performance is evaluated through objective, standardized laboratory tests against established physical, chemical, and biological criteria, not through expert interpretation of images or patient data to establish a ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. The evaluation of medical gloves against performance standards (e.g., ASTM, ISO) involves quantitative measurements and predefined pass/fail criteria, not subjective interpretation requiring adjudication by experts.
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 a physical medical glove, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical medical glove and does not involve any algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on objective, standardized test methods and criteria defined by international and national standards (e.g., ASTM D6319, ASTM D6124, ASTM D6978, ISO 10993, 21 CFR 800.20). These standards establish the acceptable performance characteristics for medical gloves. For biocompatibility, it's based on "passes" criteria of ISO standards. For chemotherapy permeation, it's the objectively measured breakthrough detection time.
8. The sample size for the training set:
- This is not applicable. The device is a physical medical glove and does not utilize a "training set" in the context of machine learning or AI. Its design and manufacturing are based on engineering principles and material science, not data-driven model training.
9. How the ground truth for the training set was established:
- This 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.