(162 days)
The Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) 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 with chemotherapy drugs.
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) meets all the requirements of ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.
This document is a 510(k) premarket notification for Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black). It describes the device and compares it to a predicate device (Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Green), K180476).
Since this document is for a medical glove, not an AI/ML powered medical device, the information requested in the prompt related to AI/ML device studies (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not applicable. The device's performance is demonstrated through non-clinical testing against recognized standards.
Here's a breakdown of the acceptance criteria and performance as gathered from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The device, "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)," meets established standards for medical examination gloves. The key acceptance criteria and reported performance, especially concerning chemotherapy drug permeation, are detailed below. The comparison is made against the predicate device (K180476) and relevant ASTM/ISO standards.
| Characteristic | Standard/Acceptance Criteria | Predicate Device (K180476) Performance | Subject Device (K190080) Performance | Comparison |
|---|---|---|---|---|
| General | ASTM D6319-10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application | Meets ASTM D6319-10(2015) requirements | Meets ASTM D6319-10(2015) requirements | Same |
| Dimensions | ASTM 6319-10 (2015): Length-Min 240mm; Thickness palm and finger-Min 0.05mm | Length-Min 240mm; Thickness palm and finger-Min 0.05mm | Length-Min 230mm; Thickness palm and finger-Min 0.05mm | Similar |
| Physical Properties | ASTM 6319-10 (2015): Min Tensile Strength (e.g., 20.23 MPa); Min Elongation (e.g., 445%) | Min - 20.23 MPa; Min - 445% | Min - 22.31 MPa; Min - 579% | Similar |
| Thickness (Finger) | ASTM 6319-10 (2015) | 0.09 mm - 0.10 mm | 0.09 mm - 0.10 mm | Similar |
| Thickness (Palm) | ASTM 6319-10 (2015) | 0.12 mm - 0.14 mm | 0.11 mm - 0.13 mm | Similar |
| Powder Content | ASTM 6124-06 (2011): ≤ 2 mg/glove | Max - 2 mg/gloves (0.20 mg/glove reported) | Max - 2 mg/gloves (0.60 mg/glove reported) | Same |
| Chemotherapy Permeation Test | ASTM D6978-05: Breakthrough Detection Time (for most listed drugs, ≥ 240 minutes) | Similar | ||
| * Cisplatin 1.0 mg/ml | ≥ 240 min | >240 min | >240 min | Same |
| * Cyclophosphamide 20 mg/ml | ≥ 240 min | >240 min | >240 min | Same |
| * Dacarbazine 10.0 mg/ml | ≥ 240 min | >240 min | >240 min | Same |
| * Doxorubicin 2.0 mg/ml | ≥ 240 min | >240 min | >240 min | Same |
| * Etoposide 20.0 mg/ml | ≥ 240 min | >240 min | >240 min | Same |
| * Fluorouracil 50.0 mg/ml | ≥ 240 min | >240 min | >240 min | Same |
| * Paclitaxel 6.0 mg/ml | ≥ 240 min | >240 min | >240 min | Same |
| * Carmustine 3.3 mg/ml | *Warning for low permeation time reported | 23.4 min | 54.1 min | Improvement |
| * Thiotepa 10.0 mg/ml | *Warning for low permeation time reported | 16.2 min | 16.0 min | Similar |
| Biocompatibility | ISO 10993-10:2010 (1. Primary Skin Irritation; 2. Skin Sensitization) | 1. Not irritating; 2. Not sensitizing | 1. Not irritating; 2. Not sensitizing | Same |
| * Cytotoxicity | ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Mild cytotoxicity reactivity (score of 2) with neat extract (100%) | Mild cytotoxicity reactivity (score of 2) with neat extract (100%) | Same |
| Watertight | 21 CFR 800.20, ASTM D5151 | Passes | Passes | Same |
| Indications for Use | Intended for medical purpose to prevent contamination and protect against chemotherapy drugs (listed above). | As described for predicate device | As described for subject device | Same |
| Material | ASTM D6319-10(2015) | Nitrile | Nitrile | Same |
| Size | Medical Glove Guidance Manual - Labeling: Extra Small, Small, Medium, Large, Extra Large | Extra Small, Small, Medium, Large, Extra Large | Extra Small, Small, Medium, Large, Extra Large | Same |
| Single Use | Medical Glove Guidance Manual - Labeling | Single Use | Single Use | Same |
Study Information for the Device:
As mentioned, much of the requested information is for AI/ML devices and is not applicable to a physical medical device like examination gloves. The provided document is a 510(k) submission, confirming substantial equivalence to a predicate device based on non-clinical performance testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated but implied to be sufficient for compliance with the referenced ASTM and ISO standards for glove testing (e.g., ASTM D6978 for chemotherapy permeation, ASTM D6319 for physical properties, ISO 10993 for biocompatibility). These standards define sampling plans for lot release testing. For instance, ISO 2859 for "Sampling Procedures and Tables for Inspection by Attributes" is referenced, indicating a statistical sampling approach.
- Data Provenance: The manufacturing company is Comfort Rubber Gloves Industries Sdn. Bhd., located in Matang, Perak, Malaysia. The testing would presumably have been conducted in laboratories, potentially in Malaysia or certified testing facilities elsewhere, in accordance with the specified international standards. The data is prospective in the sense that the tests were conducted specifically for this submission.
3. 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. The "ground truth" for a medical glove is determined by its physical and chemical properties as measured against established performance standards, not by expert interpretation of data. Laboratory testing provides the objective "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for subjective interpretations, typically in clinical readings or image analysis for AI/ML. For glove testing, objective measurements are taken according to standard protocols.
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 is a physical medical device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" is established through objective laboratory testing results against predetermined pass/fail criteria defined by international standards (ASTM, ISO). These tests measure properties such as physical dimensions, tensile strength, elongation, powder content, integrity (watertightness), chemotherapy drug permeation time, skin irritation, sensitization, and cytotoxicity.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this type of device.
§ 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.