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510(k) Data Aggregation
(51 days)
This device is intended for medical purpose that is worn on the examination between patient and examiner. In addition, these gloves were tested for use with the following chemotherapy drug concentrations per ASTM D6978-05(2019): The following drugs had NO breakthrough detected up to 240 minutes:
Cisplatin, 1.0 mg/ml (1,000 ppm) >240 min.
Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm) >240 min.
Dacarbazine,10.0 mg/ml (10,000 ppm) >240 min.
Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) >240 min.
Etoposide, 20.0 mg/ml (20,000 ppm) >240 min.
Fluorouracil,50.0 mg/ml (50,000 ppm) >240 min.
Paclitaxel,6.0 mg/ml (6,000 ppm) >240 min.
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 38.7 min.
ThioTepa10.0 mg/ml (10,000 ppm), 56.9 min
Please note that the following drug has low permeation times of less than 60 minutes:
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 38.7minutes
ThioTepa10.0 mg/ml (10.000 ppm),56.9 minutes
WARNING: Do not use Carmustine and Thiotepa
Not Found
This is an FDA 510(k) clearance letter for Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs. It's a Class I reserved device and, as such, the provided information does not describe an AI/ML device but rather a physical device (gloves). Therefore, many of the requested criteria regarding AI/ML study design are not applicable.
Here's the relevant information that can be extracted from the provided text, focusing on the device's performance regarding chemotherapy drug resistance:
Acceptance Criteria and Device Performance for Chemotherapy Drug Permeation
The acceptance criteria are implicitly defined by the test results indicating "NO breakthrough detected up to 240 minutes" for most listed chemotherapy drugs, in accordance with ASTM D6978-05(2019). For drugs with breakthrough times below 240 minutes, those times are reported, along with a warning for those under 60 minutes.
| Acceptance Criteria (Target Breakthrough Time per ASTM D6978-05(2019)) | Reported Device Performance (Minimum Breakthrough Detection Time) |
|---|---|
| No breakthrough for at least 240 minutes | Cisplatin, 1.0 mg/ml (1,000 ppm): >240 min. |
| No breakthrough for at least 240 minutes | Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm): >240 min. |
| No breakthrough for at least 240 minutes | Dacarbazine, 10.0 mg/ml (10,000 ppm): >240 min. |
| No breakthrough for at least 240 minutes | Doxorubicin HCI, 2.0 mg/ml (2,000 ppm): >240 min. |
| No breakthrough for at least 240 minutes | Etoposide, 20.0 mg/ml (20,000 ppm): >240 min. |
| No breakthrough for at least 240 minutes | Fluorouracil, 50.0 mg/ml (50,000 ppm): >240 min. |
| No breakthrough for at least 240 minutes | Paclitaxel, 6.0 mg/ml (6,000 ppm): >240 min. |
| Breakthrough time reported | Carmustine (BCNU) 3.3 mg/ml (3,300 ppm): 38.7 min. |
| Breakthrough time reported | ThioTepa 10.0 mg/ml (10,000 ppm): 56.9 min. |
Important Note: The document explicitly warns against using the gloves with Carmustine and ThioTepa due to their low permeation times (less than 60 minutes).
The following points are not applicable to this device as it is a physical medical device (examination gloves) and not an AI/ML powered diagnostic or therapeutic device. The requested information pertains to studies typically conducted for AI/ML performance evaluation.
- Sample size used for the test set and the data provenance: Not applicable. This refers to physical material testing, not data analysis.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material testing to a standard like ASTM D6978-05(2019) involves laboratory procedures, not expert consensus on medical images or diagnoses.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" used here is the physical barrier performance of the glove against specific chemical permeation, determined according to the standardized laboratory methods described in ASTM D6978-05(2019). This is a scientific, objective measurement, not based on expert consensus or clinical outcomes for diagnosis.
- The sample size for the training set: Not applicable. This concept is for AI/ML models.
- How the ground truth for the training set was established: Not applicable.
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(44 days)
Disposable Medical Synthetic Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Disposable Medical Synthetic Nitrile Examination Gloves
The provided text is a U.S. Food and Drug Administration (FDA) 510(k) clearance letter for "Disposable Medical Synthetic Nitrile Examination Gloves." This document does not describe acceptance criteria for an AI/ML device or a study proving its performance.
Instead, it's a regulatory clearance for a physical medical device (gloves), confirming its substantial equivalence to previously marketed devices. The content focuses on regulatory compliance, such as registration, labeling, manufacturing practices, and adverse event reporting for this type of conventional device.
Therefore, I cannot extract the information required to answer your questions about acceptance criteria and a study proving the device meets those criteria, as no such information is present in the provided text. The questions you've posed (regarding tables of acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) are relevant to the evaluation of AI/ML medical devices, not to the clearance of examination gloves.
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(223 days)
The Nitrile Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Nitrile Examination Gloves are patient examination gloves made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirements specifications for barrier protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. The subject device is powder free nitrile examination gloves. The subject device is in blue color.
This document is a 510(k) Pre-Market Notification for Nitrile Examination Gloves (K210706). It reports on non-clinical testing to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions | Length (mm): ≥ 230; Width (mm): S: 80 ± 10; M: 95 ± 10; L: 110 ± 10; XL: 120 ± 10; Thickness (mm): Finger: ≥ 0.05; Palm: ≥ 0.05 | Length: ≥ 230; Width: S: 80-84, M: 95-99, L: 108-111, XL: 117-121; Thickness: Finger: 0.08-0.10, Palm: 0.06-0.08 (Pass) |
| ASTM D5151 | Watertightness | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaks (Pass) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.02 mg (Pass) |
| ASTM D6319 (ASTM D412) | Physical properties (Before Aging) | Tensile Strength: ≥ 14 MPa; Ultimate Elongation: ≥ 500 % | Tensile Strength: 26-35; Ultimate Elongation: 509-545 (Pass) |
| ASTM D6319 (ASTM D412) | Physical properties (After Aging) | Tensile Strength: ≥ 14 MPa; Ultimate Elongation: ≥ 400 % | Tensile Strength: 19-36; Ultimate Elongation: 447-510 (Pass) |
| ISO 10993-5 | Cytotoxicity | Cytotoxic (Note: The acceptance criteria here is for the study to detect cytotoxicity, not to "pass" by being non-cytotoxic. The reported result then indicates observation of slight toxicity.) | Under conditions of the study, show slight potential toxicity to L-929 cells (This is the reported result, not necessarily a "pass" in the typical sense, but an observation as per the test.) |
| ISO 10993-11 | Acute systemic toxicity | Non-toxicity | Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo (Pass) |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant (Pass) |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer (Pass) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a separate "test set" in the context of an algorithm or AI model. Instead, it refers to samples tested for physical and biological properties of the nitrile gloves.
- Sample Size for Physical and Chemical Tests:
- Watertightness Test (ASTM D5151): 125 leaks (implied sample size tested to achieve 0/125 leaks).
- Other tests like physical dimensions, powder content, and physical properties (tensile strength, elongation) would have required a specific number of glove samples, but these exact numbers are not detailed in this summary. ASTM standards typically specify sample sizes for these tests.
- Data Provenance: The document does not specify the country of origin for the samples used in these non-clinical tests. The tests are for the Nitrile Examination Gloves manufactured by Niujian Technology Co., Ltd. (China). The tests themselves were conducted according to international standards (ASTM, ISO). The tests are prospective in the sense that they are performed on samples of the manufactured device to assess its compliance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This document describes the testing of a physical medical device (nitrile gloves), not an AI algorithm. Therefore, concepts like "ground truth established by experts" are not applicable in the same way. The "ground truth" for these tests is defined by the technical specifications and limits set by the ASTM and ISO standards (e.g., a glove must have a tensile strength of X MPa, or less than Y mg of powder). The results are objectively measured against these numerical or qualitative criteria by laboratory technicians.
4. Adjudication Method
Not applicable, as this is laboratory testing of a physical product against predefined physical and chemical specifications, not subjective interpretation by multiple human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI or imaging device that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical product (nitrile examination gloves), not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance of the Nitrile Examination Gloves is based on:
- Standard Specifications: Requirements outlined in established industry standards such as ASTM D6319, ASTM D5151, ASTM D6124, and ISO 10993-5, ISO 10993-10, ISO 10993-11. These standards define the acceptable physical dimensions, mechanical properties, freedom from holes, powder content, and biocompatibility profiles for such devices.
- Objective Measurements: Laboratory measurements and analyses conducted according to the specified test methodologies to determine if the device's properties fall within the defined acceptance criteria.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. The document describes pre-market non-clinical testing of a physical product.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for a physical device like examination gloves. The "ground truth" for the performance characteristics of the gloves (e.g., minimum tensile strength, maximum powder content) is established through regulatory standards and scientific consensus embodied in the ASTM and ISO documents.
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