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510(k) Data Aggregation
(91 days)
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand 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.
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate: Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate: Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.
This document is a 510(k) premarket notification decision letter from the FDA for several types of nitrile examination gloves. It acknowledges the substantial equivalence of the gloves to legally marketed predicate devices.
The acceptance criteria and device performance are related to the gloves' resistance to permeation by chemotherapy drugs and opioid drugs, specifically Fentanyl Citrate and Xylazine HCl. The study conducted appears to be ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold. Instead, it reports the "Minimum Breakthrough Detection Time in Minutes" for various drugs. For the purpose of this analysis, we can infer that a higher breakthrough time (ideally ">240 minutes") is the desired performance. The document explicitly highlights cases where performance is lower than presumably desired.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) - Acceptance (Inferred) | Pink Gloves Performance | Orange Gloves Performance | Blue Gloves Performance | Black Gloves Performance |
|---|---|---|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | High as possible, ideally >240. (Warning: Do Not Use) | 12.4 | 11.7 | 10.1 | 14.4 |
| Cisplatin (1.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Cytarabine (100 mg/ml) | >240 minutes | >240 | Not tested | >240 | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Etoposide (20.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Fluorouracil (50.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Ifosfamide (50.0 mg/ml) | >240 minutes | >240 | Not Tested | >240 | >240 |
| Methotrexate (25.0 mg/ml) | >240 minutes | >240 | Not Tested | >240 | >240 |
| Mitomycin C (0.5 mg/ml) | >240 minutes | >240 | Not Tested | >240 | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 minutes | >240 | Not Tested | >240 | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Thiotepa (10.0 mg/ml) | High as possible, ideally >240. (Warning: Do Not Use) | 43.1 | 43.2 | 30.2 | 29.2 |
| Vincristine Sulfate (1.0 mg/ml) | >240 minutes | >240 | Not Tested | >240 | >240 |
| Opioid Drugs | |||||
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 minutes | >240 | >240 | >240 | >240 |
| Xylazine HCl (100 mg/ml) | >240 minutes | Not Tested | >240 | >240 | >240 |
| Simulated Gastric Acid | >240 minutes | >240 | >240 | >240 | >240 |
Note: For Carmustine (BCNU) and Thiotepa, the warning "Do Not Use with Carmustine (BCNU) and Thiotepa" implies that the reported breakthrough times are considered insufficient for safe use, despite meeting some base level of detection. Thus, the implicit acceptance criterion for these specific drugs is to not use the gloves. For all other drugs where ">240" is reported, this indicates the gloves met or exceeded the 4-hour test duration without breakthrough.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample size (number of gloves or trials) used for the permeation tests. It indicates the testing was "as per ASTM D6978-05 (Reapproved 2019) Standard Practice." This ASTM standard would specify the required sample size and methodology.
The data provenance is not explicitly stated in terms of country of origin but is presented as results from a technical study. This would be a prospective test, as the gloves were submitted for testing to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This type of testing (chemical permeation) does not typically involve human experts establishing ground truth in the way medical imaging or clinical diagnoses do. The "ground truth" is established by the specified ASTM D6978-05 standard methodology, which is an objective chemical permeation test using analytical equipment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Chemical permeation testing is a laboratory-based, objective measurement, not subject to subjective adjudication by human readers/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:
Not applicable. This is a technical performance test for medical gloves, not a study involving human readers or AI in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth is based on objective chemical permeation measurements performed according to ASTM D6978-05 (Reapproved 2019) Standard Practice. This standard defines the method for detecting the breakthrough of specific chemicals through a material.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable for the same reason as point 8.
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(87 days)
Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove
The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The propose devices is powder free nitrile patient examination gloves, provided as non-sterile and disposable device. The proposed devices are provided with white, black and pink color. There are six sizes, extra-small, medium, large and extra-large, extra extra-large for optional.
This is a 510(k) summary for a medical device (Nitrile Examination Gloves), not for an AI/ML powered device, therefore, the requested information elements related to AI/ML device studies (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth establishment for training set) are not applicable.
The document describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's the table of acceptance criteria and reported device performance based on the provided document:
Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D6319 - Physical Dimensions Test | ||||
| Length (XS) | $\ge$ 220 mm | 226 mm | Pass | |
| Width (XS) | 70 ± 10 mm | 73 mm | Pass | |
| Length (S) | $\ge$ 220 mm | 225 mm | Pass | |
| Width (S) | 80 ± 10 mm | 85 mm | Pass | |
| Length (M) | $\ge$ 230 mm | 235 mm | Pass | |
| Width (M) | 95 ± 10 mm | 98 mm | Pass | |
| Length (L) | $\ge$ 230 mm | 234 mm | Pass | |
| Width (L) | 110 ± 10 mm | 115 mm | Pass | |
| Length (XL) | $\ge$ 230 mm | 235 mm | Pass | |
| Width (XL) | 120 ± 10 mm | 123 mm | Pass | |
| Length (XXL) | $\ge$ 230 mm | 235 mm | Pass | |
| Width (XXL) | $\ge$ 120 mm | 124 mm | Pass | |
| Thickness | ||||
| Finger Thickness | $\ge$ 0.08 mm | X-Small: 0.104 mm; Small: 0.106 mm; Medium: 0.104 mm; Large: 0.105 mm; X-Large: 0.106 mm; XX-Large: 0.105 mm | Pass | |
| Palm Thickness | $\ge$ 0.05 mm | X-Small: 0.059 mm; Small: 0.060 mm; Medium: 0.060 mm; Large: 0.062 mm; X-Large: 0.061 mm; XX-Large: 0.058 mm | Pass | |
| Physical Properties (Before Aging) | ||||
| Tensile Strength | $\ge$ 14 MPa | Lot1: 17.6 MPa; Lot2: 18.5 MPa; Lot3: 18.2 MPa | Pass | |
| Ultimate Elongation | $\ge$ 500% | Lot1: 552%; Lot2: 573%; Lot3: 583% | Pass | |
| Physical Properties (After Aging) | ||||
| Tensile Strength | $\ge$ 14 MPa | Lot1: 19.8 MPa; Lot2: 20.3 MPa; Lot3: 20.1 MPa | Pass | |
| Ultimate Elongation | $\ge$ 500% | Lot1: 521%; Lot2: 518%; Lot3: 526% | Pass | |
| ASTM D5151 - Freedom from Pinholes | Freedom from pinholes | Meet the requirements of ASTM D5151 Test for AQL 2.5 | Lot1: $\le$ AQL 2.5; Lot2: $\le$ AQL 2.5; Lot3: $\le$ AQL 2.5 | Pass |
| ASTM D6124 - Powder Residue | Powder Residue | $\le$ 2.0 mg | Lot1: 1.2 mg; Lot2: 1.5 mg; Lot3: 1.2 mg | Pass |
| ISO 10993-10 - Irritation | To determine if the finished device material is an irritant | Non-irritating | Under the conditions of the study, not an irritant | Pass |
| ISO 10993-10 - Sensitization | To determine if the finished device material is a sensitizer | Non-sensitizing | Under conditions of the study, not a sensitizer | Pass |
| ISO 10993-11 - Systemic Toxicity | To determine if the finished device material extracts pose a systemic toxicity concern | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo | Pass |
Study Details
- Sample size used for the test set and the data provenance: Not applicable. These are non-clinical bench tests on physical products, not an AI/ML test set. The tests were performed on "Lots" of the gloves (Lot1, Lot2, Lot3). The specific sample size for each test within these lots is not specified in this document but implied to be sufficient for meeting the ASTM/ISO standards. The data provenance is from non-clinical testing of the manufacturing output.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as these are objective physical and chemical tests, not requiring expert ground truth in the context of AI/ML evaluation.
- Adjudication method for the test set: Not applicable. The results are based on objective measurements against defined standards.
- 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 concerns a physical medical device (gloves), not an AI/ML powered device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This concerns a physical medical device (gloves), not an AI/ML powered device.
- The type of ground truth used: For physical/chemical properties (e.g., length, thickness, tensile strength, freedom from pinholes, powder residue), the "ground truth" is the quantitative measurement obtained through standardized test methods (ASTM and ISO standards) and compared against pre-defined numerical or qualitative acceptance criteria. For biocompatibility tests (irritation, sensitization, systemic toxicity), the ground truth is established by the outcome of the biological assays as per ISO 10993 standards.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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