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510(k) Data Aggregation
(33 days)
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 as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powder-free class I Nitrile Patient Examination Gloves which coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs. The subject devices are identical in design and formulation to the predicate gloves of K230121.
The provided FDA 510(k) clearance letter pertains to Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black), a medical device. This type of device is classified as a Class I medical device and does not involve AI/ML technology. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance, expert qualifications, adjudication methods, effect sizes) are not applicable.
The acceptance criteria and device performance are primarily evaluated based on material properties, chemical permeation resistance, and biocompatibility, using established ASTM and ISO standards for examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
The device, "NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE & BLACK)", was tested against various physical, chemical, and biological criteria.
| Test Category | Characteristic / Standard | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Preamble | Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO, OPJ |
| Intended Use | To prevent contamination between patient and examiner | Meets stated intended use | |
| Design | Powder Free, Non-Sterile, Ambidextrous, Beaded Cuff | Powder Free, Non-Sterile, Ambidextrous, Beaded Cuff | |
| Construction | Ambidextrous, Polymer Coated or Chlorinated, Powder Free Nitrile | Ambidextrous, Polymer Coated or Chlorinated, Powder Free Nitrile | |
| Color Description | Blue & Black | Blue & Black | |
| Material | Nitrile | Nitrile | |
| Single Use | Yes | Yes | |
| Packaging | Packed in Dispenser Boxes | Packed in Dispenser Boxes | |
| Sterility | Non-Sterile | Non-Sterile | |
| Freedom From Holes | ASTM D6319-19, ASTM D5151-19 | Meet requirement inspection level G-1, AQL 2.5 | Pass |
| Dimension | ASTM D6319-19 | Length (XS), min. 220mm | Meet 220mm min |
| Length (S, M, L, XL), min. 230mm | Meet 230mm min | ||
| Thickness (palm/finger), min. 0.05mm | Meet 0.05mm min | ||
| Width (XS), 70 ± 10 mm | Meet 70 ± 10 mm | ||
| Width (S), 80 ± 10 mm | Meet 80 ± 10 mm | ||
| Width (M), 95 ± 10 mm | Meet 95 ± 10 mm | ||
| Width (L), 110 ± 10 mm | Meet 110 ± 10 mm | ||
| Width (XL), 120 ± 10 mm | Meet 120 ± 10 mm | ||
| Physical Properties (Before Ageing) | ASTM D6319-19 | Tensile Strength, 14 MPa min. | Meet 14MPa min. |
| Ultimate Elongation, 500% min. | Meet 500% min. | ||
| Physical Properties (After Accelerated Aging) | ASTM D6319-19 | Tensile Strength, 14 MPa min. | Meet 14MPa min. |
| Ultimate Elongation, 400% min. | Meet 400% min. | ||
| Residual Powder Content | ASTM D6319-19, ASTM D6124-06 | Not more than 2 mg per glove | Meet 2mg/glove max. |
| Biocompatibility - Primary Skin Irritation | ISO 10993-10 | Not a primary skin irritant | Pass (did not cause an irritant response) |
| Biocompatibility - Skin Sensitization | ISO 10993-10 | Not a contact sensitizer | Pass (did not produce a skin sensitization effect) |
| Biocompatibility - In Vitro Cytotoxicity | ISO 10993-5:2009 | No adverse biological reaction | Moderate cytotoxicity reactivity at 6.0 cm²/mL extract concentrations and no cytotoxicity reactivity at 3.0 cm²/mL extract concentrations. |
| Biocompatibility - Acute Systemic Toxicity | ISO 10993-11 | No adverse biological reaction | Pass (no adverse biological reaction) |
| Chemotherapy Drug Permeation | ASTM D6978-05 (Reapproved 2019) | Varies by drug (Breakthrough Detection Time) | See detailed table below |
Detailed Chemotherapy Drug and Fentanyl Citrate Permeation Performance:
| Chemotherapy Drugs and Fentanyl Citrate | Concentration | Minimum Breakthrough Detection Time (minutes) - Blue Glove | Minimum Breakthrough Detection Time (minutes) - Black Glove |
|---|---|---|---|
| *Carmustine (BCNU) | 3.3 mg/ml | 22.6 | 21.8 |
| Cisplatin | 1.0 mg/ml | >240 min | >240 min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | >240 min | >240 min |
| Dacarbazine | 10.0 mg/ml | >240 min | >240 min |
| Doxorubicin HCL | 2.0 mg/ml | >240 min | >240 min |
| Etoposide | 20.0 mg/ml | >240 min | >240 min |
| Fluorouracil | 50.0 mg/ml | >240 min | >240 min |
| Ifosfamide | 50.0 mg/ml | >240 min | >240 min |
| Mitoxantrone | 2 mg/ml | >240 min | >240 min |
| Paclitaxel | 6.0 mg/ml | >240 min | >240 min |
| *Thio Tepa | 10.0 mg/ml | 43.9 | 17.7 |
| Vincristine Sulfate | 1.0 mg/ml | >240 min | >240 min |
| Methotrexate | 25.0 mg/ml | >240 min | >240 min |
| Mitomycin C. | 0.5 mg/ml | >240 min | >240 min |
| Fentanyl Citrate | 100mcg/2ml | >240 min | >240 min |
| *Warning: Do not use with Carmustine and Thiotepa due to extremely low permeation times. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes for each test (e.g., number of gloves tested for permeation, holes, dimensions, etc.) but refers to adherence to the methodologies outlined in the specified ASTM and ISO standards. These standards typically define minimum sample sizes for material testing.
- Data Provenance: The document states the applicant is from Malaysia (Careglove Global Sdn. Bhd.). The testing was conducted according to international standards (ASTM, ISO), implying the tests were performed in a controlled laboratory environment, likely by the manufacturer or a contracted lab. The data is non-clinical and derived from prospective testing of manufactured glove samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is not an AI/ML device that requires expert review for "ground truth" establishment in the context of diagnostic or interpretive tasks. The "ground truth" for material properties is established by the physical and chemical measurements themselves, according to standardized protocols and certified laboratory equipment.
4. Adjudication Method for the Test Set
Not applicable. This device is not an AI/ML device that requires adjudication for interpretations. Test results are objective measurements against predefined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. MRMC studies are relevant for diagnostic or interpretive AI/ML devices where human readers' performance is evaluated with and without AI assistance. This is a physical and chemical barrier device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. This device is a passive physical barrier and does not involve any algorithms or software.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on objective measurements of physical properties (e.g., length, thickness, tensile strength, elongation), chemical resistance (breakthrough detection time), and biological reactivity (biocompatibility tests), as defined by internationally recognized standards (ASTM, ISO). There is no subjective human "ground truth" in this context.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that undergoes "training."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device. The manufacturing process of the gloves is designed to meet the specified standards, and quality control ensures consistency, but this is not "training" in the context of AI/ML.
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(118 days)
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.
Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powderfree variation of the class I Nitrile Patient Examination Gloves which is coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs and Fentanyl Citrate.
This document describes the testing for Nitrile Examination Gloves, focusing on their resistance to chemotherapy drugs and Fentanyl Citrate. The study assesses the gloves' physical properties, biocompatibility, and chemical permeation alongside the reported device performance.
1. Table of Acceptance Criteria and Reported Device Performance
Chemotherapy and Fentanyl Citrate Permeation (Minimum Breakthrough Detection Time)
| Chemotherapy Drugs | Concentration | Acceptance Criteria (from ASTM D6978-05 implied by claim of use) | Reported Device Performance (Blue Glove) | Reported Device Performance (Black Glove) |
|---|---|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml | No specific public acceptance criterion provided but tested | 22.6 minutes | 21.8 minutes |
| Cisplatin | 1.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Dacarbazine | 10.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Doxorubicin HCl | 2.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Etoposide | 20.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Fluorouracil | 50.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Ifosfamide | 50.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Mitoxantrone | 2 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Paclitaxel | 6.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Thiotepa | 10.0 mg/ml | No specific public acceptance criterion provided but tested | 43.9 minutes | 17.7 minutes |
| Vincristine Sulfate | 1.0 mg/ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Fentanyl Citrate Injection | 100mcg/2ml | No specific public acceptance criterion provided but tested | >240 minutes | >240 minutes |
| Warning | Advised against use if permeation time is too low | Carmustine, Thiotepa warning | Carmustine, Thiotepa warning |
Physical Properties, Dimensional, and Biocompatibility Testing
| Test | Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Freedom From Holes | ASTM D6319-19, D5151-19 | Requirement inspection level G-1, AQL 2.5 | Pass |
| Dimension (Length, Thickness, Width) | ASTM D6319-19 | Length: min. 220mm, 230mm. Thickness: min. 0.05mm. Width: 70-120mm (based on size) | Pass (Meets requirements for various sizes) |
| Physical Properties (Before Aging) | ASTM D6319-19 | Tensile Strength: 14 MPa min. Ultimate Elongation: 500% min. | Pass (Meets 14MPa min, 500% min) |
| Physical Properties (After Aging) | ASTM D6319-19 | Tensile Strength: 14 MPa min. Ultimate Elongation: 400% min. | Pass (Meets 14MPa min, 400% min) |
| Residual Powder Content | ASTM D6319-19, D6124-06 | Not more than 2 mg per glove | Pass |
| Primary Skin Irritation Test | ISO 10993-10 | Not a primary skin irritant | Pass (Did not cause an irritant response) |
| Skin Sensitization Test | ISO 10993-10 | Not a contact sensitizer | Pass (Did not produce a skin sensitization effect) |
| In Vitro Cytotoxicity Test | ISO 10993-5:2009 | No adverse biological reaction | Moderate cytotoxicity at 6.0 cm²/mL; No reactivity at 3.0 cm²/mL |
| Acute Systemic Toxicity | ISO 10993-11 | No adverse biological reaction | Pass (No adverse biological reaction) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of gloves) used for the permeation, physical property, or biocompatibility tests.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). However, the tests were conducted according to international standards (e.g., ASTM, ISO), which implies a standardized, prospective testing approach in a laboratory setting. The applicant is based in Malaysia.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study involving expert readers or ground truth established by medical professionals. The "ground truth" for this device is determined by objective, standardized laboratory measurements (e.g., chemical permeation time, physical properties, biological reactions) as defined by the referenced ASTM and ISO standards.
4. Adjudication Method for the Test Set
Not applicable. There was no human adjudication process involved as the "ground truth" is determined by objective laboratory measurements and adherence to specified test standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The device in question is examination gloves, and its performance is evaluated through physical, chemical, and biological testing, not by human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a medical device (examination gloves), not an AI algorithm. Therefore, the concept of "standalone" performance for an algorithm does not apply. All listed tests are "standalone" in the sense that they assess the intrinsic properties of the glove without human intervention in the measurement process itself, though human technicians conduct and analyze the tests.
7. The Type of Ground Truth Used
The ground truth used for this study is based on:
- Performance Standards: Defined by international standards such as ASTM D6978-05 (for chemotherapy drug permeation), ASTM D6319-19, ASTM D5151-19, ASTM D6124-06 (for physical properties and hole freedom), and ISO 10993-10, ISO 10993-5:2009, ISO 10993-11 (for biocompatibility).
- Objective Laboratory Measurements: Direct measurements of breakthrough time, dimensional properties, tensile strength, elongation, residual powder, and biological response to the glove materials.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned or implied in this submission, as the device is not an AI/ML algorithm that requires training data.
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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