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510(k) Data Aggregation
(154 days)
The Polyisoprene Surgical Gloves are single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. It is provided sterile.
Polyisoprene Surgical gloves
I am sorry, but the provided text from the FDA document (K240790) pertains to the clearance of "Polyisoprene Surgical gloves" and focuses entirely on regulatory information, such as:
- The FDA's decision regarding the 510(k) premarket notification.
- Classification of the device (Class I, reserved).
- Applicable regulations (e.g., 21 CFR 878.4460 for Non-Powdered Surgeon's Glove, Quality System regulation 21 CFR Part 820).
- Guidance on changes requiring new premarket notifications.
- Information on adverse event reporting and other regulatory compliance.
- The "Indications for Use" for the surgical gloves.
This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details related to AI/algorithm-based medical devices. It is a regulatory clearance letter for a non-software/AI medical device.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details based on the provided text.
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(225 days)
These surgical gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with chemotherapy drugs, have low dermatitis potential, and are nonpyrogenic. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber, are white in color, and are available in sizes 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy.
This document is a 510(k) premarket notification for a medical device: "Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential" (K230079). It compares the new device to a predicate device (K190018) and provides evidence of performance through various tests.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents a comparison of the subject device (K230079) against a predicate device (K190018) and also summarizes non-clinical testing. Below is a compilation of the acceptance criteria (standards/guidance/test criteria) and the reported device performance.
| Test/Characteristic | Acceptance Criteria (Standard/Guidance/Criteria) | Reported Device Performance (K230079) |
|---|---|---|
| Chemotherapy Permeation | ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs | All drugs with BDT >240 minutes met criteria.Carmustine (BCNU) (3.3 mg/ml): 12.6 minutesThiotepa (10.0 mg/ml): 26.6 minutes (Note: For marketing, the device labels a warning against using with Carmustine and Thiotepa due to "extremely low permeation times".) |
| Dimensions (Length) | ASTM D3577 requirements: Minimum 265mm | Pass |
| Dimensions (Palm Width) | ASTM D3577 requirements (specific to each size 5.5-9.0, e.g., 5.5: 70±6mm, 9.0: 114±6mm) | Pass for all sizes |
| Dimensions (Thickness - Finger) | ASTM D3577 requirements: Minimum 0.10mm | Pass |
| Dimensions (Thickness - Palm) | ASTM D3577 requirements: Minimum 0.10mm | Pass |
| Dimensions (Thickness - Cuff) | ASTM D3577 requirements: Minimum 0.10mm | Pass |
| Physical Properties | ASTM D3577-19 requirements for tensile strength, ultimate elongation, and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves | Pass |
| Freedom from holes | ASTM D3577-19 and ASTM D5151-06 requirements; AQL 1.5 | Pass |
| Powder-Free | ASTM D3577-19, ASTM D6124-06 requirements: ≤ 2 mg per glove | Pass |
| Sterility | ANSI/AAMI/ISO 11137-1:2018 requirement of 10^-6 SAL | Pass |
| ISO In Vitro Cytotoxicity | ISO 10993-5:2009: Non-cytotoxic (as the general acceptance criteria) | Under the conditions of the study, the device was found to be cytotoxic. However, "the device extracts did not elicit acute systemic response in the animal model" in the follow-up Acute Systemic Toxicity test (ISO 10993-11). This is a notable finding, indicating the device failed the initial cytotoxicity but was deemed safe due to subsequent testing. |
| ISO Skin Irritation Study | ISO 10993-10:2010: Not an irritant | Pass |
| ISO Maximization Sensitization Study | ISO 10993-10:2010: Not a sensitizer | Pass |
| ISO Acute Systemic Toxicity Study | ISO 10993-11:2006: No mortality or evidence of acute systemic toxicity | Pass (addressed after initial cytotoxicity finding) |
| Human Skin Sensitization | Modified Draize-95 Test (per FDA guidance): Not a sensitizer (demonstrates low dermatitis potential) | Pass: "The results showed low dermatitis potential for the human subject tested." |
| Endotoxin Study | Less than 20.0 EU/device | Pass: "test results indicate low endotoxin level" |
| Material Mediated Pyrogenicity Study | ISO 10993-11:2017: Meets the material mediated pyrogenicity requirement | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Chemotherapy Drug Permeation (ASTM D6978-05): The document specifies the standard used but does not provide the exact sample size for the test sets (number of gloves or replicates per drug). The data is generated from laboratory testing ("under the conditions of the study"). Data provenance is not explicitly stated but implies laboratory testing for regulatory submission.
- Dimensions, Physical Properties, Freedom from Holes, Powder-Free, Sterility: These tests refer to ASTM and ISO standards (e.g., ASTM D3577, ASTM D5151, ASTM D6124, ISO 11137-1). These standards typically define the sampling plans (e.g., AQL 1.5 for freedom from holes), but the specific number of units tested for this submission is not directly stated. Data provenance implies manufacturer's testing for regulatory submission.
- Biocompatibility (ISO 10993 series): These are biological evaluations. The document refers to "the conditions of the study" and "animal model" for acute systemic toxicity but does not provide specific sample sizes (e.g., number of animals used). Data provenance implies laboratory testing for regulatory submission.
- Human Skin Sensitization (Modified Draize-95 Test): This test was performed on "human subject tested." The sample size (number of human subjects) is not explicitly given, it ambiguously states "the human subject tested." Data provenance is from a clinical test as per FDA guidance.
- Endotoxin Study & Material Mediated Pyrogenicity Study: The document refers to "the conditions of the study" but does not provide sample sizes. Data provenance implies laboratory testing for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This submission is for a physical device (surgical gloves) and its material properties, not an AI/algorithm-driven device requiring expert image interpretation or similar ground truth establishment. Therefore, the concept of "experts" establishing a ground truth in that context is not applicable here. The "ground truth" for the performance tests (e.g., breakthrough time, tensile strength) is established by the validated methodologies of the referenced ASTM and ISO standards.
4. Adjudication Method for the Test Set:
Not applicable in the context of material and physical property testing of a device like surgical gloves. Test results are objective measurements based on defined standard protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This is not an AI device or a diagnostic imaging device where human reader performance is evaluated.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
Not applicable as this is not an AI/algorithm device. The performance tests evaluate the physical gloves without any "human-in-the-loop" interaction in the testing methodology itself beyond conducting the tests.
7. The Type of Ground Truth Used:
- Objective Measurement Standards: For most physical and chemical properties (dimensions, strength, freedom from holes, powder, sterility, chemotherapy permeation, endotoxin, pyrogenicity), the "ground truth" is defined by the objective measurement criteria and methodologies specified in the referenced ASTM and ISO standards. The results are quantitative measurements against these predefined thresholds.
- Biological Response in Models: For biocompatibility tests (cytotoxicity, skin irritation, sensitization, acute systemic toxicity), the "ground truth" is established by observing biological responses in in vitro or in vivo (animal) models as per ISO 10993 standards and the Modified Draize-95 Test for human skin sensitization.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set. The device is a manufactured physical product.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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(187 days)
The Polyisoprene Surgical Gloves are sterile and single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination.
The proposed device is Polyisoprene Surgical Gloves, sterile and disposable devices. The proposed devices are made of polyisoprene. The proposed device is white. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D3577.
The provided document is a 510(k) summary for Polyisoprene Surgical Gloves, which are a Class I medical device. The document does not describe an AI/ML-enabled device or an diagnostic device requiring an MRMC study or AI-specific acceptance criteria.
The acceptance criteria provided in the document relate to the physical and biological characteristics of the surgical gloves as per various ASTM and ISO standards, and the "study" is a series of non-clinical performance tests confirming the gloves meet these established standards.
Therefore, I cannot extract information related to AI/ML device performance, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or training set details as these are not relevant to the product described in the input.
However, I can extract the acceptance criteria and performance data for the Polyisoprene Surgical Gloves as presented in the document.
Acceptance Criteria and Reported Device Performance (for Polyisoprene Surgical Gloves)
1. Table of Acceptance Criteria and Reported Device Performance
| No. | Name of the Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| 1 | ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Skin Sensitization. | Assesses possible contact hazards released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization. | Skin Sensitization Test: provided grades less than 1, otherwise sensitization. | All grades are 0. All animals were survived, and no abnormal signs were observed during the study. |
| 2 | ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation | Assesses possible contact hazards released from medical devices, which may produce skin and mucosal irritation, eye irritation or skin sensitization. | Skin Irritation Test: If the primary irritation index is 0-0.4, the response category is Negligible. 0.5-1.9 means slight, 2-4.9 means moderate, 5-8 means severe. | The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition. |
| 3 | ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity | Describes test methods to assess the in vitro cytotoxicity of medical devices. | The viab.% of the 100% extract of the test article is the final result, and if viability is reduced to <70% of the blank, it has cytotoxic potential. | Viab.% of 100% test article extract is 6.1%. It means the proposed device have potential toxicity to L-929 in the MTT method. |
| 4 | ISO 10993-11: 2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | To evaluate the potential for medical device materials to cause adverse systemic reactions. | Within the monitoring period (72 h), if the toxicosis response of testing group is not greater than that of control group, the testing sample is regarded as acceptable. | There was no evidence of systemic toxicity from the extract. |
| 5 | ISO 10993-7 standards for EO/ECH residual testing | Specifies allowable limits for residual ethylene oxide (EO). | Limit (< 24 h) EO 4 mg; ECH 9 mg. Prolonged (> 24 h < 30 d) EO 60 mg/30 d; ECH 60 mg/30 d. | EO residue: ≤ 4mg in the first 24h; ≤ 60mg in the first 30d; EO residue shall also ≤ 10ug/g; ECH residue: ≤ 9mg in the first 24h; ≤ 60mg in the first 30d. |
| 6 | ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves | Designed to determine the amount of residual powder (or filter-retained mass) found on medical gloves. | powder residue limit of 2.0 mg | 0.1mg/glove |
| 7 | ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. 12/23/2019 | Covers the detection of holes in medical gloves. | Samples number: 200 gloves; AQL: 1.5 (ISO 2859); Criterion ≤7 gloves for water leakage. | 0 glove water leakage found |
| 8 | ASTM D5712-15 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method | Intended to test NR, latex, and elastomeric materials for residual protein content. | Have a recommended aqueous soluble protein content limit of 200 ug/dm² | 52ug/dm² |
| 9 | ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Intended as a reference to the performance and safety of rubber surgical gloves. | Dimensions: -6.5: width 83±6mm, Length ≥265 mm -7: width 89±6mm, Length ≥265 mm -7.5: width 95±6mm, Length ≥265 mm -8: width 102±6mm, Length ≥265 mm Thickness: -Finger ≥0.10 mm -Palm ≥0.10 mm -Cuff ≥0.10 mm Physical properties: ● Before aging ● Tensile strength ≥17MPa ● Ultimate Elongation ≥ 650% ● Stress at 500% Elongation ≤ 7.0 MPa ● After Accelerated Aging ● Tensile strength ≥12MPa ● Ultimate Elongation ≥ 490% | Dimensions: 6.5: width: 83-84 mm, Length 280-289 mm Thickness: Finger 0.230-0.260 mm, Palm 0.188-0.207 mm, Cuff 0.137-0.151 mm 7: width 91-93 mm, Length 271-278 mm Thickness: Finger 0.211-0.241 mm, Palm 0.181-0.193 mm, Cuff 0.133-0.144 mm 7.5: width 96-98 mm, Length 273-280 mm Thickness: Finger 0.218-0.237mm, Palm 0.180-0.192 mm, Cuff 0.136-0.146 mm 8: width 103-105 mm, Length 268-283 mm Thickness: Finger 0.221-0.272 mm, Palm 0.189-0.212 mm, Cuff 0.143-0.153 mm Physical properties: Before aging -Tensile strength 25.2-30.9 MPa -Ultimate Elongation 721% - 777% -Stress at 500% Elongation 6.5-7.0 MPa After Accelerated Aging -Tensile strength 23.0-29.0 MPa -Ultimate Elongation 680% - 716% |
2. Sample Size Used for the Test Set and Data Provenance:
- Holes in Medical Gloves (ASTM D5151-19): 200 gloves were sampled for this specific test.
- Other tests (Biological, Chemical, Physical property tests): The document does not specify a distinct "test set" sample size for each individual test beyond the 200 gloves for hole detection. Standard methodologies like ISO and ASTM usually define sample sizes for their respective tests, which are implicitly followed.
- Data Provenance: Not specified, but the applicant company is Puyang Linshi Medical Supplies Co., Ltd. in China, suggesting the testing was likely conducted in China or by labs cooperating with them. The document does not state if the data is retrospective or prospective; it describes non-clinical performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This device is surgical gloves, not a diagnostic device requiring expert interpretation for ground truth. Ground truth is established by physical and chemical test results against international standards.
4. Adjudication Method for the Test Set:
- Not applicable. This is not an image-based diagnostic or AI/ML device requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, this type of study is not applicable to surgical gloves. It is typically conducted for diagnostic devices (e.g., AI in radiology).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used:
- The ground truth is established by adherence to recognized international standards and test methodologies (e.g., ISO 10993 series for biological evaluation, ASTM D6124, D5151, D3577 for physical and chemical properties). This involves laboratory measurements and observations based on predefined criteria.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device, so there is no training set.
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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