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510(k) Data Aggregation
(5 days)
The Disposable Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is Pink/Cool Gary/Green/Rose Gold. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
The provided document is a 510(k) premarket notification for a Disposable Nitrile Examination Glove. It details the device, its intended use, and non-clinical testing performed to establish substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM D6319 - Physical Dimensions | Length (mm): S: ≥220; M/L/XL: ≥230 | Length (mm): >230/Pass (for all sizes M, L, XL)(Note: S-size length not explicitly stated as >230 but presumably passed since the general length is >230 mm) |
| Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | Width (mm): S: 84-89 /Pass; M: 94-97/ Pass; L: 104-111/ Pass; XL:113-116/ Pass | |
| Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Thickness (mm): Finger: 0.12-0.14/Pass; Palm: 0.11-0.13/Pass | |
| ASTM D5151 - Watertightness (Holes) | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | 0/125/Pass (This implies 0 failures out of 125 samples, meeting the AQL) |
| ASTM D6124 - Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.08-0.13mg/Pass |
| ASTM D412 - Physical Properties (Tensile Strength & Elongation) | Before Aging:Tensile Strength: ≥14MPaUltimate Elongation: ≥500% | Before Aging:Tensile Strength: 14-28 MPa/Pass;Ultimate Elongation: 503-568 %/Pass |
| After Aging:Tensile Strength: ≥14MPaUltimate Elongation: ≥400% | After Aging:Tensile Strength: 14-25 MPa/Pass;Ultimate Elongation: 424-544 %/Pass | |
| ISO 10993-5 - Cytotoxicity | Non-cytotoxic | Under conditions of the study, device extract is cytotoxic (This result is contradictory to a "Pass" result in the table). However, in a previous table (page 5), it states "device extract is cytotoxic", implying it was tested. Then in the results of the same table (page 7) it states "Under conditions of the study, device extract is cytotoxic." This is an interesting discrepancy, as typically "cytotoxic" would be a failure for "non-cytotoxic" acceptance. The summary of non-clinical performance testing (table on page 6) lists "Non-cytotoxic" as the acceptance criteria and then "Under conditions of the study, device extract is cytotoxic." as Results. This appears to be a clerical error in the document, as it would likely not be cleared if it failed this. For this response, I will assume it passed based on the overall conclusion. |
| ISO 10993-11 - Acute Systemic Toxicity | Non-acute systemic toxicity | Under conditions of the study, 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
- Sample Size for Test Set:
- For Watertightness (holes), the result "0/125/Pass" indicates a sample size of 125 gloves were tested.
- For other tests (Physical Dimensions, Powder Content, Physical Properties, Biocompatibility), specific sample sizes are not explicitly stated in the provided text.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that Jiangsu Cureguard Glove Co., Ltd. is based in China, it is highly probable the testing was conducted in China. The non-clinical tests described are typically prospective studies where a batch of the device is manufactured and then tested.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable (N/A) as the device is a physical product (nitrile gloves) and the testing performed consists of objective, quantifiable physical and chemical tests against established standards. There is no "ground truth" to be established by experts in the context of diagnostic performance or clinical interpretation.
4. Adjudication Method for the Test Set
This information is not applicable (N/A) for the same reason as point 3. The tests are objective and based on direct measurement or observation against defined criteria, not subjective interpretation requiring adjudication.
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 typically performed for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and AI assistance is being evaluated for its impact on their performance. The disposable nitrile examination glove is a Class I medical device and does not involve such diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone "algorithm only" performance study was not done. This concept applies to AI/ML software as a medical device (SaMD). The disposable nitrile examination glove is a physical product, not an algorithm. The non-clinical tests assess the physical and biological properties of the glove itself.
7. The Type of Ground Truth Used
The "ground truth" used in these non-clinical tests is based on established standard specifications (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993 series). These standards define objective, measurable criteria for the physical, chemical, and biological properties of medical gloves.
8. The Sample Size for the Training Set
This information is not applicable (N/A). There is no "training set" as this device does not involve machine learning or AI algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable (N/A) for the same reason as point 8.
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(169 days)
The Disposable Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is Black/Lavender/Navy Blue/Burgundy. It can be available in five specifications: XS,S,M,L and XL.
The subject device is non-sterile.
This document is a 510(k) Premarket Notification for a Disposable Nitrile Examination Glove. It details the device's characteristics and compares it to a predicate device (K171422) to establish substantial equivalence.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): XS/S: $\ge$ 220; M/L/XL: $\ge$ 230; Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | Length(mm): > 230/Pass; Width(mm): XS: 70-77 /Pass; S: 77-86 /Pass; M: 95-99/ Pass; L: 109-114/ Pass; XL:117-120/ Pass |
| N/A (Section 6) | Thickness (mm) | Finger: ≥0.05; Palm: ≥0.05 | Finger: 0.08-0.11/Pass; Palm: 0.08-0.11/Pass |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: ≥14MPa; Ultimate Elongation: ≥500% | Tensile Strength: 15.3-17.9MPa/Pass; Ultimate Elongation: 496-588%/Pass |
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: ≥14MPa; Ultimate Elongation: ≥400% | Tensile Strength: 20.0-44.5MPa/Pass; Ultimate Elongation: 450-5710%/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass (This implies 0 failures out of 125 samples tested) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.03-0.07mg/Pass |
| ISO 10993-5 | Biocompatibility - Cytotoxicity | Under conditions of the study, device extract is not cytotoxic (implied expectation, as the reported result confirms this) | Under conditions of the study, device extract is cytotoxic (This seems to be a typo/inconsistency in the document. The acceptance criterion from the predicate comparison is "Under conditions of the study, device extract is cytotoxic", implying the absence of cytotoxicity is the goal. The reported performance for ISO 10993-5 is the phrase "Toxicity" with the acceptance criteria being "Under conditions of the study, device extract is cytotoxic". This is highly confusing. Based on standard biocompatibility testing, the desired outcome for cytotoxicity is non-cytotoxic. However, the "Table 2 - Summary of non-clinical performance testing" explicitly lists "Toxicity" as the purpose and "Under conditions of the study, device extract is cytotoxic" as both the acceptance criteria and implied result. This is a critical discrepancy in the provided text. For a medical device, a cytotoxic extract would typically not be acceptable. Assuming the intent was for it to be non-cytotoxic, and that the "Results" column would show "Pass" for non-cytotoxicity, there's a clear error in the document as presented.) |
| ISO 10993-11 | Biocompatibility - Systemic Toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo | Non-acute systemic toxicity / Pass |
| ISO 10993-10 | Biocompatibility - Irritation | Under the conditions of the study, not an irritant | Non-irritating / Pass |
| ISO 10993-10 | Biocompatibility - Sensitization | Under conditions of the study, not a sensitizer | Non-sensitizing / Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Watertightness Test (ASTM D5151): The reported performance "0/125/Pass" indicates a sample size of 125 units were tested.
- Other tests: The sample sizes for the remaining tests (Physical Dimensions, Thickness, Physical Properties, Powder Content, Biocompatibility) are not explicitly stated in the provided document.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer is Jiangsu Cureguard Glove Co., Ltd. in China, so it's reasonable to infer the testing was conducted in China, but this is not explicitly confirmed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device (Disposable Nitrile Examination Glove) is a Class I medical device, which typically relies on established engineering and materials standards (e.g., ASTM, ISO) rather than expert human interpretation of complex medical images or outcomes.
- Therefore, the concept of "experts" establishing a "ground truth" as it would apply to AI/imaging diagnostics does not apply to the performance testing described for this device. The ground truth is defined by the objective measurement specifications in the referenced standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Again, due to the nature of the device and testing (physical and chemical properties measured against objective standards), no adjudication method of expert opinions was used or necessary. The results are based on objective measurements.
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
- An MRMC study is not applicable to this type of device. This device is a disposable examination glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical product, not an algorithm or software. The "standalone" performance is simply the device's ability to meet the specified physical, chemical, and biological criteria.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for this device's performance testing is defined by objective engineering and material standards (e.g., ASTM D6319 for dimensions, ASTM D412 for physical properties, ASTM D5151 for watertightness, ASTM D6124 for powder content, and ISO 10993 series for biocompatibility). These standards provide the measurable criteria that the device must meet.
8. The sample size for the training set
- This is not applicable as the device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- This is not applicable as the device is a physical product, not an AI model.
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(97 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl patient examination gloves. During the production process, about 1% ~ 3% nitrile is added to the ingrove the tensile strength and ultimate elongation of the glove. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
The provided text is a 510(k) Summary for a medical device (Disposable Synthetic Vinyl Nitrile Examination Glove). It outlines acceptance criteria and test results for various non-clinical tests. Since the device is not an AI/ML powered device, the questions related to AI/ML powered devices are not applicable.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | Length(mm): $\ge$ 230;Width(mm):XS: 75 $\pm$ 5;S: 85 $\pm$ 5;M: 95 $\pm$ 5;L: 105 $\pm$ 5;XL: 115 $\pm$ 5;Thickness (mm):Finger: $\ge$ 0.08Palm: $\ge$ 0.08 | Length: >230/ PassWidth:XS: 78-80/ PassS: 85-86/PassM: 95-96/PassL: 105-106/PassXL: 115-116/PassFinger Thickness:XS: 0.11-0.12/PassS:0.11-0.12/PassM:0.11-0.13/PassL:0.11-0.13/PassXL:0.11-0.13/PassPalm Thickness:XS:0.08-0.09/PassS:0.08-0.09/PassM:0.08-0.09/PassL:0.08-0.09/PassXL:0.08-0.09/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL=2.5 | XS:0/125;S:1/125;M:3/125; L:2/125;XL:2/125 leaks / Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | XS:0.89 mg/Pass; S: 0.92 mg/Pass; M: 0.91 mg/Pass; L: 0.92 mg/Pass; XL: 0.95 mg/Pass; |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: $\ge$ 11MPaUltimate Elongation: $\ge$ 300% | Not explicitly reported as specific values for the subject device in the table, but the comparison section notes they "meet the requirements of ASTM D5250". |
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: $\ge$ 11MPaUltimate Elongation: $\ge$ 300% | Not explicitly reported as specific values for the subject device in the table, but the comparison section notes they "meet the requirements of ASTM D5250". |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells./ 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 the data provenance
- ASTM D5151 (Watertightness): For detection of holes, the sample size was 125 gloves per size (XS, S, M, L, XL), with results like "XS:0/125; S:1/125; M:3/125; L:2/125; XL:2/125 leaks".
- ASTM D6124 (Powder Content): The sample size appears to be one glove per size for the reported powder content (e.g., "XS:0.89 mg/Pass").
- For other tests (ASTM D5250 Physical Dimensions, ASTM D412 Physical Properties, ISO 10993-5 Cytotoxicity, ISO 10993-10 Irritation and Sensitization), specific sample sizes are not detailed in the provided summary.
- Data Provenance: The document does not explicitly state the country of origin for the test data or whether it was retrospective or prospective. Given the submitter's address in China, it is likely the testing was conducted there.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML powered device, and the tests relate to physical and biological properties, not interpretation by experts.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements against defined standards, not requiring adjudication by 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 not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on established industry standards and regulatory requirements (e.g., ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-5, ISO 10993-10). The "ground truth" is adherence to these specifications as measured by laboratory testing.
8. The sample size for the training set
Not applicable. This is not an AI/ML powered device, and therefore does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML powered device.
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(72 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in five sizes: extra-small, small, medium, large, and extra-large.
The provided document is a 510(k) summary for a medical device: "Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)". It details the non-clinical testing conducted to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, based on your requested format:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | ||
| Length (mm) | XS/S: ≥220; M/L/XL: ≥230 | All reported lengths were >230 mm (Pass) | |
| Width (mm) | XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | All reported widths for three lots were within specified ranges (Pass) | |
| Thickness (mm): Finger | ≥0.05 | All reported finger thicknesses for three lots were ≥0.08 mm (Pass) | |
| Thickness (mm): Palm | ≥0.05 | All reported palm thicknesses for three lots were ≥0.08 mm (Pass) | |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | XS: 0/125 leaks; S: 1/125 leaks; M: 0/125 leaks; L: 0/125 leaks; XL: 0/125 leaks (Pass) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.10 mg (Pass) |
| ASTM D412 | Physical properties (Before Aging) | ||
| Tensile Strength | ≥14MPa | Lot 1: 15.4-17.1; Lot 2: 15.6-17.3; Lot 3: 15.7-16.6 (Pass) | |
| Ultimate Elongation | ≥500% | Lot 1: 542-580; Lot 2: 542-570; Lot 3: 545-562 (Pass) | |
| ASTM D412 | Physical properties (After Aging) | ||
| Tensile Strength | ≥14MPa | Lot 1: 15.6-17.0; Lot 2: 15.8-17.0; Lot 3: 15.4-19.2 (Pass) | |
| Ultimate Elongation | ≥400% | Lot 1: 546-577; Lot 2: 547-572; Lot 3: 536-571 (Pass) | |
| ASTM D6978 | Chemotherapy Drugs Tested with Minimum Breakthrough Detection Time | ||
| Carmustine (BCNU) 3.3 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Note: Predicate had 25.3 min, Subject has 22.9 min for this drug as a point of comparison) | 22.9 Minutes (Warning: Do not use with Carmustine) | |
| Cisplatin 1.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Dacarbazine (DTIC) 10.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Doxorubicin HCl 2.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Etoposide 20.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Fluorouracil 50.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Methotrexate 25 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Mitomycin C 0.5 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Paclitaxel 6.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| Thio Tepa 10.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Note: Predicate had 43.7 min, Subject has 44.2 min for this drug) | 44.2 Minutes (Caution: Testing showed an average breakthrough time of 44.2 minutes with Thio-Tepa) | |
| Vincristine Sulfate 1.0 mg/ml | Not explicitly stated as "acceptance criteria" but presented as a measured performance. (Predicate had ≥240 min) | > 240 Minutes | |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. (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 the data provenance
- ASTM D6319 (Physical Dimensions, Tensile Strength, Ultimate Elongation): Data is reported for "Lot 1", "Lot 2", and "Lot 3". Each lot appears to represent multiple measurements across different sizes (XS, S, M, L, XL). The exact sample size per lot or per measurement (e.g., how many gloves were measured for length, width, thickness, or subjected to tensile tests) is not explicitly stated, but it follows the standard ASTM D6319 requirements for quality assurance.
- ASTM D5151 (Watertightness): The sample sizes are explicitly stated as 125 gloves per size: XS: 0/125 leaks, S: 1/125 leaks, M: 0/125 leaks, L: 0/125 leaks, XL: 0/125 leaks.
- ASTM D6124 (Powder Content): The sample size for powder content is not explicitly stated.
- ASTM D6978 (Chemotherapy Drug Permeation): The sample size for each drug test is not explicitly stated in the provided text.
- ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation, Sensitization): The sample sizes used for these biocompatibility tests are not explicitly stated, but the tests were conducted "under conditions of the study" which implies adherence to the standard's methodology.
- Data Provenance: All testing appears to be non-clinical (bench testing and laboratory biocompatibility tests). There is no information provided about patient data or country of origin for such data, as this is a device for which clinical testing was not deemed necessary. The testing was conducted in support of a device manufactured by Jiangsu Cureguard Glove Co., Ltd. in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" in this context is established by standardized physical, chemical, and biological testing methods (ASTM and ISO standards), not by individual expert consensus or interpretation of medical images. The results are objective measurements.
4. Adjudication method for the test set
Not applicable. The tests are based on objective measurements against predefined acceptance criteria from international standards. There is no element of subjective assessment requiring adjudication in the context of these non-clinical tests.
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 device is a medical examination glove, not an AI-powered diagnostic or therapeutic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical glove and does not involve any algorithm or AI component.
7. The type of ground truth used
The ground truth used for performance validation is based on standardized test methods and their defined performance criteria. Specifically:
- ASTM Standards: ASTM D6319 (physical properties), ASTM D5151 (freedom from holes), ASTM D6124 (powder content), and ASTM D6978 (chemotherapy drug permeation). These standards define the procedures for measurement and the expected acceptable ranges or thresholds.
- ISO Standards (Biocompatibility): ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization). These standards define the methods and parameters for assessing the biological safety of the device.
8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve AI or machine learning models that require a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
Ask a specific question about this device
(144 days)
The Disposable Nitrile Medical Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
Acceptance Criteria and Device Performance for Disposable Nitrile Medical Examination Gloves (K210691)
The provided document describes the acceptance criteria and performance data for the Disposable Nitrile Medical Examination Glove (K210691) in comparison to the predicate device (K171422). The study primarily focuses on non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results for 3 Lots) | Outcome |
|---|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test (Length) | XS/S: ≥220 mm; M/L/XL: ≥230 mm | Lot1, Lot2, Lot3: >230 mm | Pass |
| ASTM D6319 | Physical Dimensions Test (Width) | XS: 70±10 mm; S: 80±10 mm; M: 95±10 mm; L: 110±10 mm; XL: 120±10 mm | Lot1: XS: 78-80, S: 85-86, M: 95-96, L: 105-106, XL: 115-116Lot2: XS: 79-80, S: 85-86, M: 95-96, L: 105-106, XL: 115-116Lot3: XS: 78-80, S: 85-86, M: 95-96, L: 105-106, XL: 115-116 | Pass |
| ASTM D6319 | Physical Dimensions Test (Thickness) | Finger: ≥0.05 mm; Palm: ≥0.05 mm | Lot1: Finger: 0.11-0.13, Palm: 0.06-0.07Lot2: Finger: 0.11-0.13, Palm: 0.06-0.07Lot3: Finger: 0.11-0.13, Palm: 0.07 | Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | Lot1: 0/125 leaksLot2: 0/125 leaksLot3: 0/125 leaks | Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0 mg | Lot1: 0.09 mg/gloveLot2: 0.06 mg/gloveLot3: 0.08 mg/glove | Pass |
| ASTM D412 | Physical properties (Before Aging - Tensile Strength) | ≥14 MPa | Lot1: 28-36Lot2: 28-33Lot3: 23-33 | Pass |
| ASTM D412 | Physical properties (Before Aging - Ultimate Elongation) | ≥500% | Lot1: 510-570Lot2: 480-565Lot3: 515-566 | Pass |
| ASTM D412 | Physical properties (After Aging - Tensile Strength) | ≥14 MPa | Lot1: 27-33Lot2: 28-33Lot3: 28-32 | Pass |
| ASTM D412 | Physical properties (After Aging - Ultimate Elongation) | ≥500% | Lot1: 485-535Lot2: 480-530Lot3: 485-533 | Pass |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. | 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 sample size for the test set is not explicitly stated as a single number but is indicated by the "3 Lots" tested for physical properties, watertightness, and powder content. For the watertightness test (ASTM D5151), a sample size of 125 gloves per lot was tested. The data provenance is China, as the manufacturer, Jiangsu Cureguard Glove Co., Ltd., is located in China. The testing appears to be prospective as it was conducted to demonstrate compliance with standards for a new device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (medical examination glove) does not typically involve human expert interpretation or ground truth establishment in the same way an AI diagnostic tool would. The ground truth for this device is based on objective, quantitative measurements and standardized laboratory test procedures derived from established ASTM and ISO standards. Therefore, the concept of "experts" establishing ground truth for individual cases is not directly applicable here. The "experts" would be the scientists and technicians performing the standardized tests in a laboratory setting, adhering to the specified methodologies.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the testing conducted for this medical device involves objective measurements and standardized laboratory methods, not subjective interpretation requiring adjudication among human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the AI's assistance is evaluated. For medical examination gloves, the performance evaluation is based on physicochemical and biological properties against established standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable to the device under review. The device is a physical medical glove, not an algorithm or software. The performance evaluation is inherently "standalone" in the sense that the glove's properties are measured directly, without human interpretation in a diagnostic loop.
7. The Type of Ground Truth Used
The ground truth used for this device's performance evaluation is objective laboratory measurements and compliance with established international standards (ASTM and ISO). This includes:
- Physical dimensions (length, width, thickness) measured against specified ranges.
- Mechanical properties (tensile strength, ultimate elongation) measured against minimum requirements.
- Barrier integrity (freedom from holes) measured against AQL (Acceptable Quality Level).
- Chemical properties (powder content) measured against a maximum limit.
- Biocompatibility (cytotoxicity, irritation, sensitization) evaluated through in vitro and in vivo (though described as "in vitro" for cytotoxicity, the irritation and sensitization tests typically involve animal or human models as per ISO 10993-10, even if the results are presented as "non-irritant" or "non-sensitizing" without detailing the specific model here) tests against pass/fail criteria.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
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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(134 days)
The Disposable Nitrile Medical Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is white. The subject device is non-sterile.
The provided document is a 510(k) summary for a Disposable Nitrile Medical Examination Glove. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device. This document is not for an AI/ML medical device, but rather for a physical examination glove. Therefore, many of the requested criteria regarding AI/ML device acceptance, such as expert consensus, MRMC studies, training/test sets, and ground truth establishment, are not applicable to this submission.
However, I can extract and present the acceptance criteria and test results related to the physical and biocompatibility performance of the glove, as described in the document.
Acceptance Criteria and Device Performance for Disposable Nitrile Medical Examination Glove (K210684)
The device, a "Disposable Nitrile Medical Examination Glove," is classified as Class I and its performance is evaluated against established ASTM and ISO standards for medical gloves, rather than complex AI/ML performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria Reported in Document | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm):- XS/S: ≥220- M/L/XL: ≥230 | Length:- XS/S: > 220/Pass- M/L/XL: > 230/Pass |
| Width (mm):- XS: 70±10- S: 80±10- M: 95±10- L: 110±10- XL: 120±10 | Width:- XS: 78-80 / Pass- S: 85-89 /Pass- M: 95-99/ Pass- L: 105-111/ Pass- XL: 115-120/ Pass | ||
| Thickness (mm):- Finger: ≥0.05- Palm: ≥0.05 | Thickness:- Finger: 0.09-0.13/Pass- Palm: 0.07-0.13/Pass | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaks / Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0 mg | 0.07 mg/Pass |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: ≥14 MPaUltimate Elongation: ≥500% | Tensile Strength:- XS:29-31/Pass- S:27-32/Pass- M:28-33/Pass- L:25-33/Pass- XL:28-31/PassUltimate Elongation:- XS:520-565/Pass- S:520-575/Pass- M:520-565/Pass- L:510-565/Pass- XL:525-563/Pass |
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: ≥14 MPaUltimate Elongation: ≥400% | Tensile Strength:- XS:26-31/Pass- S:28-32/Pass- M:27-31/Pass- L:28-33/Pass- XL:28-31/PassUltimate Elongation:- XS:480-520/Pass- S:490-525/Pass- M:485-530/Pass- L:490-545/Pass- XL:480-530/Pass |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells./ 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 |
Non-Applicable Criteria for this Device:
The following requested information is primarily relevant to AI/ML (Artificial Intelligence/Machine Learning) medical devices, which typically involve algorithms processing data (e.g., images, signals) to make predictions or assist in diagnoses. The submitted device, a medical examination glove, is a physical product and its testing is based on established performance standards for materials and manufacturing. Therefore, these items are not applicable to this 510(k) submission:
2. Sample size used for the test set and the data provenance: Not applicable. Tests are standard physical and chemical property evaluations on manufactured gloves, not a data-based test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is defined by physical/chemical standards, not expert medical opinion on a data set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. No AI component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device is based on established international standards (ASTM, ISO) for physical properties and biocompatibility of medical gloves.
8. The sample size for the training set: Not applicable. No training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.
Summary of Study (Non-Clinical Testing):
The study described is a series of non-clinical tests conducted to verify that the Disposable Nitrile Medical Examination Glove meets design specifications and complies with relevant international standards. The tests cover:
- Physical Dimensions: Length, width, and thickness for various glove sizes.
- Physical Properties: Tensile strength and ultimate elongation, both before and after accelerated aging, to assess durability and flexibility.
- Freedom from Holes: Watertightness testing to ensure barrier integrity.
- Powder Content: To confirm it is "powder free" as claimed.
- Biocompatibility: Tests for irritation, sensitization, and cytotoxicity to ensure the material is safe for contact with human skin.
The document reports that all tests demonstrated the proposed device complies with the specified standards and meets the acceptance criteria, leading to the conclusion that it is as safe and effective as the legally marketed predicate device.
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(106 days)
Powder Free Vinyl Patient Examination Gloves, White Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Vinyl Patient Examination Gloves, White Color that meets all of the requirements of ASTM standard D 5250-06e1.
This document describes the acceptance criteria and performance for "Powder Free Vinyl Patient Examination Gloves, White Color".
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 e1. | Meets |
| Physical Properties | ASTM standard D 5250-06 e1. | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 e1 and D6124-06 | Meets (<2mg/glove) |
| Biocompatibility | Primary Skin Irritation in rabbits (AAMI / ANSI / ISO 10993-10) | Passes (Not a Primary Skin Irritation) |
| Dermal sensitization in the guinea pig (AAMI / ANSI / ISO 10993-10) | Passes (Not a Dermal sensitization) |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test (Dimension, Physical Properties, Freedom from pinholes, Powder Residual, Biocompatibility). However, it implies testing was conducted according to the referenced ASTM standards and 21 CFR regulations, which would stipulate appropriate sample sizes for these types of tests.
The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. Given the submitter's address is in China (Jiangsu Cureguard Gloves Co.,Ltd.), the testing was likely conducted in China. These would be prospective tests specifically performed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the device is a medical glove, and "ground truth" in the context of expert consensus, pathology, or outcomes data is not relevant for its mechanical and biological safety testing. The "ground truth" is established by the specifications of the referenced ASTM standards and regulatory requirements (21 CFR).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable, as there is no subjective interpretation or need for expert adjudication in the objective physical and chemical tests performed on the gloves. The results are quantitative measurements against defined standards.
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:
This is not applicable. This device is a passive medical glove, not an AI-powered diagnostic or assistive device. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This device is a medical glove, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is based on objective measurement standards and regulatory criteria. These include:
- ASTM standard D 5250-06 e1 (for dimension, physical properties, powder residual)
- 21 CFR 800.20 (for freedom from pinholes)
- ASTM D6124-06 (for powder residual)
- AAMI / ANSI / ISO 10993-10 (for biocompatibility - primary skin irritation and dermal sensitization)
8. The sample size for the training set:
This is not applicable. The device is a medical glove, not a machine learning model, so there is no concept of a "training set".
9. How the ground truth for the training set was established:
This is not applicable, as there is no training set for this type of device.
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(69 days)
Powdered vinyl 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.
powdered vinyl patient examination gloves, (Light Yellow) that meets all of the requirements of ASTM standard D 5250-06.
The provided text describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves (Light Yellow)." This is a medical device submission, specifically for patient examination gloves, which are low-risk devices. Therefore, the acceptance criteria and study design are different from what would be expected for a complex AI/ML diagnostic or prognostic device.
Here's the breakdown of the information based on your request, tailored to this type of device:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-06 | < 10 mg/dm² |
| Biocompatibility: | ||
| --> Primary Skin Irritation | Per ISO10993-10 or equivalent (rabbits) | Passes; Not a Primary Skin Irritation |
| --> Dermal Sensitization | Per ISO10993-10 or equivalent (guinea pig) | Passes; Not a Dermal sensitization |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for pinholes, how many animals for biocompatibility). However, the tests are conducted according to established standards (ASTM, FDA regulations, ISO), which inherently define the sampling methods and acceptance levels.
- Provenance: This is a physical product (gloves), not data in the sense of patient records or images. The "data" provenance refers to the testing conducted on the manufactured gloves. There is no mention of country of origin for the data (testing results), but the manufacturer is based in China. The tests are non-clinical and would be considered prospective for the specific batch of gloves tested to support the submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in the context of this device. "Ground truth" usually refers to diagnostic accuracy in complex medical imaging or clinical decision-making. For these gloves, "ground truth" is established by direct measurement against a defined engineering or biological standard. For example, a pinhole is objectively present or absent based on a waterleak test. Biocompatibility tests are performed by trained laboratory personnel following established protocols, not by "experts" establishing a subjective ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. The tests are objective measurements against defined criteria (e.g., glove dimensions, force at break, waterleak test for pinholes, standardized biological assays). There is no subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. MRMC studies are used for evaluating diagnostic performance of imaging devices or algorithms with human readers. This device is a medical glove, not a diagnostic tool requiring interpretation by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product (glove), not an algorithm or AI system.
7. The Type of Ground Truth Used:
- The "ground truth" for the acceptance criteria is defined by industry standards (ASTM D 5250-06, ASTM D6124-01) and regulatory requirements (21 CFR 800.20, ISO10993-10). This includes:
- Engineering specifications: For dimensions, physical properties (tensile strength, elongation), and powder amount.
- Physical test results: For freedom from pinholes (waterleak test).
- Biological assay results: For biocompatibility (primary skin irritation and dermal sensitization tests in animal models).
8. The Sample Size for the Training Set:
- Not applicable. This is a manufactured product, without a "training set" in the AI/ML sense. The manufacturing process uses quality control, and the design itself is based on general engineering principles for glove production, not machine learning.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no "training set" for this device. The design specifications and manufacturing process are established based on the requirements of the ASTM standards and FDA regulations, informed by decades of glove manufacturing and material science.
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(39 days)
Powder free vinyl 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.
powder free vinyl patient examination gloves, (Light Yellow) that meets all of the requirements of ASTM standard D 5250-06.
The provided text describes the 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves (Light Yellow)." As such, the information contained does not pertain to the development or validation of a medical AI device. Instead, it details the safety and effectiveness information for a physical medical device (examination gloves) compared to a predicate device.
Therefore, many of the requested sections about AI device validation criteria, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance, are not applicable to this document.
Here's an analysis of the available information based on the provided text, focusing on the acceptance criteria and the study (or tests) proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-01 | <2mg/glove |
| Biocompatibility (Primary Skin Irritation) | ISO10993-10 | Passes (in rabbits) |
| Biocompatibility (Dermal Sensitization) | ISO10993-10 | Passes (in guinea pig), Not a Dermal sensitization |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for each test listed (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility). The studies are non-clinical, involving material performance and animal testing.
- Provenance: Non-clinical tests, likely conducted in a laboratory setting by the manufacturer or contracted labs in China (submitter's country). These are a series of tests against established international and US standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. For physical device performance and biocompatibility, ground truth is established through adherence to standardized test methods and criteria defined by regulatory bodies (e.g., ASTM, FDA, ISO). No human expert consensus for a "ground truth" in the way it's used for AI models is described or relevant here.
4. Adjudication Method for the Test Set
Not applicable. The tests are laboratory-based and follow predefined protocols for pass/fail criteria, rather than requiring adjudication by multiple human observers.
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 not an AI device, and therefore no MRMC study or assessment of human reader improvement with AI assistance was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI algorithm. The performance described is the standalone performance of the physical glove itself based on material science and manufacturing quality tests.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Standardized Test Methods and Specifications: Adherence to defined parameters and limits set by ASTM (American Society for Testing and Materials), FDA regulations (e.g., 21 CFR 800.20 for freedom from pinholes), and ISO standards (e.g., ISO10993-10 for biocompatibility). These standards provide the objective criteria against which the device's performance is measured.
- Predicate Device Comparison: The device is deemed substantially equivalent to a legally marketed predicate device (K070076) that also meets these standards.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for a physical product like examination gloves. The "ground truth" for ensuring the product meets its specifications is established through quality control processes and adherence to manufacturing standards designed to consistently produce gloves meeting the performance criteria outlined in the standards (ASTM, FDA, ISO).
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(45 days)
Powder free vinyl 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.
powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
Device: Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)
Summary of Device Performance Study:
The provided text describes a premarket notification for a medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies for Class I devices like examination gloves. The "study" in this context refers to the nonclinical tests conducted to prove the device meets established standards and is comparable to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-00c4 | Meets |
| Physical Properties | ASTM standard D 5250-00c4 | Meets |
| Freedom from Pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-00c4 & D6124-01 | <2mg/glove |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation in rabbits | Passes (Not a Primary Skin Irritation) |
| Biocompatibility (Dermal Sensitization) | Dermal sensitization in guinea pig | Passes (Not a Dermal sensitization) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes used for each of the nonclinical tests (Dimension, Physical Properties, Freedom from Pinholes, Powder Residual, Biocompatibility). It only states that the device "meets" the standards.
- Data Provenance: The tests are nonclinical, laboratory-based evaluations against established material and performance standards. The country of origin of the data is not explicitly stated, but it would have been generated in a laboratory setting. The data is prospective in the sense that the manufacturer conducted these tests specifically for this device to demonstrate compliance prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not applicable in the context of this submission. For nonclinical tests like those for examination gloves, the "ground truth" is defined by the objective, measurable parameters outlined in the ASTM and CFR standards. Expert consensus or review by human experts with specific qualifications (like radiologists) is typically not involved in establishing the ground truth for these types of physical and chemical performance tests. Laboratory technicians and chemists would perform these tests against the predefined standards.
4. Adjudication Method for the Test Set:
- This is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations, particularly in medical image analysis or clinical assessments. For objective nonclinical tests, the results either meet the specified numerical or qualitative criteria of the standard, or they do not. There's no "adjudication" in the traditional sense; rather, it's a direct comparison of measured results against published thresholds.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation (e.g., radiology AI). The device in question is a physical barrier (examination glove), and its performance is assessed through nonclinical, laboratory-based tests against material and functional standards, not by human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, this is not applicable. A standalone algorithm performance study is relevant for AI/ML-based diagnostic devices. The device is a physical product, not an algorithm.
7. The Type of Ground Truth Used:
- The ground truth used for these nonclinical tests is based on established industry and regulatory standards and specifications. Specifically:
- ASTM Standard D 5250-00c4: For dimensions, physical properties, and powder residual. These standards define the acceptable ranges and methodologies.
- 21 CFR 800.20: For freedom from pinholes (waterleak test AQL). This is a regulatory standard defining acceptable defect rates.
- ASTM D6124-01: For powder residual, providing a specific methodology and threshold.
- ISO10993-10: For biocompatibility, which outlines methods for testing irritation and sensitization. The "ground truth" for biocompatibility is derived from the biological responses (or lack thereof) observed in animal models (rabbits for irritation, guinea pigs for sensitization), interpreted according to the standard.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its performance is based on the inherent physical and chemical properties of the manufactured product, which are tested against defined standards.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As the device is not an AI/ML algorithm, there is no training set or corresponding ground truth to establish in that context.
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