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510(k) Data Aggregation
(117 days)
Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel
PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential
The Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® Eclipse Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber lates, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® Surgeons Natural rubber latex surgical gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Biogel® Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI Micro Indicator Underglove Blue polyisoprene surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI UltraTouch S Polyisoprene surgical gloves for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI UltraTouch S Indicator Underglove Blue polyisoprene surgical indicator underglove for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® Eclipse Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber lates, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® Surgeons Natural rubber latex surgical gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Biogel® Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI Micro Indicator Underglove Blue polyisoprene surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI UltraTouch S Polyisoprene surgical gloves for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The Biogel® PI UltraTouch S Indicator Underglove Blue polyisoprene surgical indicator underglove for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
The document provides information on the performance of several types of surgical gloves when tested for resistance to permeation by chemotherapy drugs. The acceptance criteria and the study method are based on ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance:
The implicit acceptance criterion for these gloves, based on the Breakthrough detection time values and the common understanding in such tests, is that the gloves should demonstrate resistance to permeation by chemotherapy drugs for a reasonable duration (e.g., as long as possible, or at least a certain minimum time). While a specific "pass/fail" threshold is not explicitly stated as an acceptance criterion in minutes, the values of ">240 minutes" indicate excellent performance for most drugs. The lower values for Carmustine and Thiotepa highlight instances where permeation occurs more quickly.
The reported device performance for each glove type and chemotherapy drug is provided in the tables across the document. Below is a summary table combining this information as an example, for "Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents" (from page 3):
| Drug and Concentration | Acceptance Criteria (Breakthrough Detection Time - implicit goal) | Reported Device Performance (Breakthrough detection time in minutes (0.01µg/cm²/mins)) |
|---|---|---|
| Bleomycin 15 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Busulfan 6 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Carmustine 3.3 mg/ml | As long as possible, ideally >240 minutes | 12.1 |
| Cisplatin 1 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Cytarabine HCL 100 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Dacarbazine (DTIC) 10 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Doxorubicin HCL 2 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Ellence 2 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Etoposide (Toposar) 20 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Fludarabine 25 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Fluorouracil 50 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Idarubicin 1 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Ifosfamide 50 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Mechlorethamine HCl 1 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Melphalan 5 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Methotrexate 25 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Mitomycin C 0.5 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Mitoxantrone 2 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Paclitaxel (Taxol) 6 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Paraplatin 10 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Rituximab 10 mg/ml | As long as possible, ideally >240 minutes | >240 |
| Thiotepa 10 mg/ml | As long as possible, ideally >240 minutes | 14.1 |
| Vincristine Sulfate 1 mg/ml | As long as possible, ideally >240 minutes | >240 |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for the test set (number of gloves tested per drug type). It only reports the breakthrough detection time.
The data provenance is from testing conducted in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a standardized, laboratory-based prospective testing methodology. The country of origin of the data is not specified, but the submission is to the U.S. FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of study (chemical permeation testing of medical devices) does not typically involve human expert adjudication in the same way, for example, a diagnostic image interpretation study would. The "ground truth" is established by the objective, quantitative measurement of chemical permeation according to the specified ASTM standard. Therefore, there are no "experts" in the sense of clinical reviewers establishing a ground truth.
4. Adjudication Method for the Test Set:
Not applicable. As described above, this is a laboratory test with objective measurements, not a human interpretation task requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a standalone performance test of a physical device against chemical permeation, not an AI-assisted diagnostic task involving human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This entire study is a standalone performance assessment of a physical device. There is no "algorithm" or "human-in-the-loop" concept involved. The performance is the intrinsic resistance of the glove material to chemical permeation.
7. The Type of Ground Truth Used:
The ground truth used is based on objective, quantitative measurements of chemical permeation using analytical methods specified or implied by the ASTM D6978 standard. The "Breakthrough detection time" is the measured outcome, indicating the time at which a quantifiable amount of the chemotherapy drug permeates through the glove material.
8. The Sample Size for the Training Set:
Not applicable. This is a direct performance test of a manufactured product, not a machine learning model. There is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for this type of device performance study.
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(221 days)
Biogel PI Micro Indicator Underglove
The Biogel® PI Micro Indicator Underglove is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
The subject device is a single-use disposable powder-free surgical glove that is supplied sterile and made from synthetic polyisoprene material (not made from natural rubber latex).
The provided text describes a 510(k) summary for the Biogel® PI Micro Indicator Underglove (K150146). This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI algorithm or its performance.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set size) are not applicable to this document as it pertains to a physical medical device (surgical glove) and not an AI/ML-driven device.
However, I can extract the acceptance criteria and reported device performance related to the physical characteristics and biocompatibility of the surgical glove.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (Results Summary) |
|---|---|
| Biocompatibility: | |
| Primary Skin Irritation (ISO 10993-10) | Under the conditions of the study, not an irritant. |
| ISO Closed Patch Sensitization (ISO 10993-10) | Under the conditions of the study, not a sensitizer. |
| Physical Characteristics: | |
| Dimensions (ASTM D3577) | Meets ASTM D3577 requirements for length, width, and thickness. |
| Physical Properties (ASTM D3577) | Meets ASTM D3577 requirements for tensile strength and elongation at break before and after accelerated aging. |
| Freedom from holes (21 CFR 800.20 and ASTM D3577, tested according to ASTM D5151) | Exceeds 21 CFR 800.20 and ASTM D3577 requirements of AQL 1.5. |
| Powder residual (ASTM D3577 tested according to ASTM D6124) | Meets powder level requirements for "Powder-free" designation per ASTM D3577. |
Details Not Applicable to this Document:
- Sample size used for the test set and the data provenance: Not applicable. This document describes testing for a physical device, not an AI algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to the results of standardized physical and biological tests on the glove material.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI algorithms, not a physical surgical glove.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: For physical characteristics and biocompatibility, the ground truth is established by the specified ASTM and ISO standards for measuring these properties (e.g., tensile strength, hole detection via water leak test, irritation response).
- The sample size for the training set: Not applicable. There is no AI algorithm being trained.
- How the ground truth for the training set was established: Not applicable.
This submission is primarily comparing a new physical device (Biogel® PI Micro Indicator Underglove) to a previously cleared predicate device (Biogel® PI Indicator® Underglove) based on established regulatory standards for surgical gloves.
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