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BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free
A 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.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder Free Nitrile Patient Examination Glove, Non-Sterile (Blue) meet all the requirements of ASTM standard D6319-19 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.
This document describes the safety and efficacy of "Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K213408) by comparing its performance to a predicate device (K192954) and established ASTM standards. The study focuses on non-clinical testing, particularly the glove's resistance to permeation by chemotherapy drugs and fentanyl citrate.
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for this device are based on meeting or exceeding the minimum breakthrough detection times for various chemotherapy drugs and fentanyl citrate, as specified by ASTM D6978-05 (Reapproved 2019). Other criteria include physical properties, dimensions, watertight integrity, residual powder, and biocompatibility.
| Test Method / Characteristic | Standard | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|
| Physical Properties | ASTM D412-16 | |||
| - Tensile Strength (Before aging) | Min 14 MPa | 14.4 MPa | Pass | |
| - Tensile Strength (After aging) | Min 14 MPa | 16.3 MPa | Pass | |
| - Ultimate Elongation (Before aging) | Min 500% | 506% | Pass | |
| - Ultimate Elongation (After aging) | Min 400% | 402% | Pass | |
| Dimension | ASTM D3767-03 | |||
| - Length | Min 240mm | Min 240mm | Pass | |
| - Width (XS) | 70 ± 10 mm | Ave = 72 mm | Pass | |
| - Width (S) | 80 ± 10 mm | Ave = 83 mm | Pass | |
| - Width (M) | 95 ± 10 mm | Ave = 95 mm | Pass | |
| - Width (L) | 110 ± 10 mm | Ave = 104 mm | Pass | |
| - Width (XL) | >110 mm | Ave = 115 mm | Pass | |
| - Thickness (Finger) | Min 0.05mm | 0.08mm | Pass | |
| - Thickness (Palm) | Min 0.05mm | 0.05mm | Pass | |
| Water Tight | ASTM D5151-19 | AQL 1.5 (Acceptance No: 14 for 500 samples) | 12 leaks found (within acceptance) | Pass |
| Residual Powder | ASTM D6124-06 | Less than 2 mg per glove | 1.5 mg/glove | Pass |
| Permeation by Chemotherapy Drugs | ASTM D6978-05 | ≥240mins (general) | ≥240mins (for most drugs) | Pass |
| - Carmustine (BCNU) 3.3mg/ml | No specific criterion for low BT | 22.5mins | (Noted as low permeation time, warnings issued) | |
| - Thio Tepa 10 mg/ml | No specific criterion for low BT | 36.1mins | (Noted as low permeation time, warnings issued) | |
| Fentanyl Citrate Permeation | ASTM D6978-05 | ≥240mins | >240mins | Pass |
| Biocompatibility | ||||
| - Primary Skin Irritation | ISO 10993-10:2010 | Not a primary skin irritant | Not a primary skin irritant (PII "0") | Pass |
| - Dermal Sensitization | ISO 10993-10:2010 | Not a contact sensitizer | Not a contact sensitizer | Pass |
| - Cytotoxicity - MEM Elution | ISO 10993-5:2009 | No cytotoxicity reactivity at certain extract concentrations | Severe cytotoxicity reactivity at 100%, 50%, and 25% extract concentrations; No cytotoxicity at 12.5%, 6.25%, and 3.125% extract concentrations | Not Pass (as it did not pass for 100%, 50% and 25% extract concentrations) |
| - Acute Systemic Toxicity | ISO 10993-11:2017 (E) | No adverse biological reaction | No adverse biological reaction | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Physical Properties (Tensile Strength, Elongation): Sample size not explicitly stated for individual tests, but implied to be sufficient for ASTM standards.
- Dimension: Sample size not explicitly stated.
- Water Tight: Sample size of 500 pieces (based on AQL level M for a batch of 500,001 or more).
- Residual Powder: Sample size of 5 pieces.
- Permeation by Chemotherapy Drugs and Fentanyl Citrate: Sample size not explicitly stated, but tests were performed per ASTM D6978-05.
- Biocompatibility (Primary Skin Irritation, Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity): Sample sizes for the animal testing are not explicitly reported in this summary, but the results indicate standard testing procedures were followed.
- Data Provenance: The standard testing was conducted by Meditech Gloves Sdn Bhd, located in Malaysia. The study is a non-clinical study assessing the device's characteristics against recognized standards. It is implicitly a prospective evaluation for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This document describes non-clinical laboratory testing. There is no indication of human experts establishing "ground truth" for the test set in the way a clinical study would involve expert readers. The ground truth is defined by the objective measurement criteria within the ASTM and ISO standards used (e.g., specific permeation detection limits, physical property thresholds, AQL levels).
4. Adjudication Method for the Test Set:
Not applicable. This is a non-clinical device test where results are determined by objective measurements against established standard criteria, not by human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a patient examination glove, and the study focuses on its material and barrier properties, not on diagnostic accuracy involving human readers. Therefore, an MRMC study was not performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a physical medical device (glove), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth for this study is based on predefined technical specifications and validated test methodologies outlined in international standards such as:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D6978-05 (Reapproved 2019) (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs)
- ASTM D412-16 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension)
- ASTM D3767-03(2020) (Standard Practice for Rubber—Measurement of Dimensions)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-06 (2017) (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-10:2010 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization)
- ISO 10993-5:2009 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity)
- ISO 10993-11:2017 (E) (Biological evaluation of medical devices – Part 11: Tests for systemic toxicity)
The performance of the gloves is directly measured against the quantitative and qualitative acceptance criteria specified in these standards.
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device that requires a training set. The device is a physical product whose performance is evaluated through material and chemical barrier integrity tests.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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