(84 days)
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous, and come in different sizes - Extra Small, Small, Medium, Large and Extra Large.
Gloves meet the specification of ASTM D6319-10 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05, as guide lined by the FDA Medical Glove Guidance Manual.
This document describes the premarket notification for "Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs" (K172525). The primary purpose of the submission is to demonstrate substantial equivalence to a predicate device (K163146) based on technological characteristics and performance data, particularly regarding resistance to chemotherapy drug permeation.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to ASTM standards and comparative performance against the predicate device.
| Acceptance Criteria/Standard | Reported Device Performance |
|---|---|
| ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application): | Device "meets the specification of ASTM D6319-10" and demonstrates "the standard specifications and performance are appropriate for the requirements of powder free nitrile examination gloves and specialty chemotherapy gloves." |
| * Physical Properties (Before Aging): | |
| * Tensile Strength | 15 Mpa min |
| * Ultimate Elongation | 500% min |
| * Physical Properties (After Aging): | |
| * Tensile Strength | 14 Mpa min |
| * Ultimate Elongation | 400% min |
| * Freedom from Holes (ASTM D5151-06) | In accordance with ASTM D5151-06, following ASTM D6319 AQL 2.5/Inspection Level G-I |
| * Powder Content | Max. 0.52 mg per glove |
| ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs): | Gloves "have been tested for use with chemotherapy drugs using ASTM D6978-05" and "will be labeled with a statement of compliance and a summary of the testing results." |
| * Chemotherapy Drug Permeation (Minimum Breakthrough Detection Time in minutes) | |
| * Carmustine (3.3 mg/ml) | 12.4 minutes |
| * Cisplatin (1.0 mg/ml) | No breakthrough for up to 240 minutes |
| * Cyclophosphamide (20 mg/ml) | No breakthrough for up to 240 minutes |
| * Doxorubicin HCl (2.0 mg/ml) | No breakthrough for up to 240 minutes |
| * Etoposide (20.0 mg/ml) | No breakthrough for up to 240 minutes |
| * Fluorouracil (50.0 mg/ml) | No breakthrough for up to 240 minutes |
| * Mitoxantrone (2.0 mg/ml) | No breakthrough for up to 240 minutes |
| * Paclitaxel (6.0 mg/ml) | No breakthrough for up to 240 minutes |
| * Thiotepa (10.0 mg/ml) | 24.4 minutes |
| * Dacarbazine (10.0 mg/ml) | No breakthrough for up to 240 minutes |
| * Ifosfamide (50.0 mg/ml) | No breakthrough for up to 240 minutes |
| * Vincristine Sulfate (1.0 mg/ml) | No breakthrough for up to 240 minutes |
| Biocompatibility Testing | "Under the conditions of the study, the proposed device is not a sensitizer, or an irritant." These studies were performed on the proposed device. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not explicitly state the sample size used for each specific test (e.g., number of gloves tested for permeation, holes, or physical properties). However, it implies that the testing was conducted "in accordance with ASTM D5151-06, following ASTM D6319 AQL 2.5/Inspection Level G-I" for freedom from holes, which dictates sample size based on lot size and AQL. For other tests like chemotherapy drug permeation (ASTM D6978-05), the standard itself would define the testing methodology and implied sample size per drug.
- Data Provenance: The manufacturer, Central Medicare Sdn. Bhd., is located in Teluk Intan, Perak, Malaysia. The tests were likely conducted in Malaysia or by a testing facility in adherence to the specified ASTM standards. The data is retrospective in the sense that it represents characterization of the manufactured gloves to support the 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
This device is not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for glove performance is established through standardized physical and chemical tests (e.g., ASTM D6319-10, ASTM D6978-05). The "experts" are the qualified laboratory personnel performing these tests according to the standard operating procedures of the testing facilities. Their qualifications typically involve training and certification in laboratory testing methodologies relevant to material science and medical device performance standards.
4. Adjudication Method for Test Set
Not applicable for this type of device and testing. Test results are objective measurements from standardized protocols rather than subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical medical device (examination glove), not an imaging or diagnostic AI system.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Not applicable. This is a physical medical device. The performance evaluated is the physical and chemical properties of the glove itself.
7. Type of Ground Truth Used
The ground truth used is based on:
- Performance Standards: Adherence to established industry standards such as ASTM D6319-10 (for general glove properties) and ASTM D6978-05 (for chemotherapy drug permeation).
- Objective Laboratory Measurements: Direct measurements of tensile strength, elongation, freedom from holes, powder content, and breakthrough times for chemotherapy drugs. These are quantifiable results obtained through controlled experimental procedures.
- Biocompatibility Studies: In vitro or in vivo tests to assess sensitization and irritation, which also yield objective results based on established protocols.
8. Sample Size for Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The "device" is a physical product.
9. How Ground Truth for Training Set Was Established
Not applicable, as no training set is relevant for this 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.