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510(k) Data Aggregation
(99 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 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 four sizes: small, medium, large, and extra-large.
This document describes the acceptance criteria and the study proving that the "Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)" meet these criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
The device was tested against several standards, as detailed in the "Summary of Non-Clinical Testing" section (pages 8-13). Here's a summary:
| No. | Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 1 | ISO 10993-10:2010 (Skin Sensitization) | Grades less than 1. | All grades were 0. All animals survived with no abnormal signs. The device is not a sensitizer. |
| 2 | ISO 10993-10:2010 (Skin Irritation) | Primary irritation index of 0-0.4 for "Negligible" response. | The primary irritation index was 0. The response was categorized as negligible. The device is not an irritant. |
| 3 | ISO 10993-5:2009 (In Vitro Cytotoxicity) | Viability ≥ 70% of the blank (if viability is reduced to <70%, it has cytotoxic potential). | Viability of 100% test article extract was 21.0%. This indicates potential toxicity to L-929 in the MTT method. (However, refer to Analysis3 in the document stating that systemic toxicity test showed the device is safe despite potential cytotoxicity). |
| 4 | ISO 10993-11:2017 (Systemic Toxicity) | Within 72h, test group toxicosis response not greater than control group. | No evidence of systemic toxicity from the extract. |
| 5 | ASTM D6124-06 (Residual Powder) | Powder residue limit of 2.0 mg per glove. | 0.09-0.11 mg per glove. |
| 6 | ASTM D5151-06 (Freedom from Holes) | Samples number: 125 gloves. AQL: 2.5 (ISO 2859). Criterion ≤7 gloves for water leakage. | No glove water leakage found. |
| 7 | ASTM D6319-10 (Physical Properties - Sterility, Dimensions, Tensile Strength, Ultimate Elongation) | Sterility: No need (Non-sterile device) Freedom from holes: Refer to No. 6 Dimensions: Length S: ≥220mm; M, L, XL: ≥230mm. Width S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm. Thickness: Finger ≥0.05mm; Palm ≥0.05mm. Before Aging: Tensile strength ≥ 14MPa; Ultimate Elongation ≥ 500%. After Accelerated Aging: Tensile strength ≥ 14MPa; Ultimate Elongation ≥ 400%. | Sterility: N.A. Freedom from holes: Refer to No. 6. Dimensions: Lot 210515: S: LxW 245-254mm x 82-85mm; M: LxW 249-255mm x 91-94mm; L: LxW 252-260mm x 102-105mm; XL: LxW 250-262mm x 112-115mm. Thickness F: 0.11-0.12mm; P: 0.08mm. Lot 210518: S: LxW 252-255mm x 83-85mm; M: LxW 250-256mm x 91-96mm; L: LxW 254-261mm x 101-106mm; XL: LxW 254-258mm x 111-116mm. Thickness F: 0.11mm; P: 0.08mm. Lot 210520: S: LxW 246-250mm x 82-86mm; M: LxW 245-249mm x 91-95mm; L: LxW 252-259mm x 103-107mm; XL: LxW 254-258mm x 112-116mm. Thickness F: 0.11-0.12mm; P: 0.07-0.08mm. Before Aging: Tensile strength 15.2-24.4 MPa; Ultimate Elongation 525.655% - 798.544%. After Accelerated Aging: Tensile strength 14.0-18.7MPa; Ultimate Elongation 578.552% - 745.388%. |
| 8 | ASTM D6978-05 (Chemotherapy Drug Permeation) | Minimum breakthrough detection times for various chemotherapy drugs (specified in the Indications for Use and Table 4 of the 510(k) summary). | Carmustine (BCNU) 3.3 mg/ml: 23.6 Minutes (min.) Cisplatin 1.0 mg/ml: > 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml: > 240 Minutes Dacarbazine 10 mg/ml: > 240 Minutes Doxorubicin HCl 2.0 mg/ml: > 240 Minutes Etoposide 20.0 mg/ml: > 240 Minutes Fluorouracil 50.0 mg/ml: >240 Minutes Methotrexate, 25 mg/ml: >240 Minutes Mitomycin C, 0.5 mg/ml: >240 Minutes Paclitaxel 6.0 mg/ml: >240 Minutes Thio Tepa 10.0 mg/ml: 37.4 Minutes (min.) Vincristine Sulfate, 1mg/ml: >240 Minutes |
2. Sample Size Used for the Test Set and Data Provenance:
The document provides the following details:
- ASTM D5151 (Freedom from Holes): Sample size of 125 gloves. The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated but is implied to be from laboratory testing conducted as part of the regulatory submission process.
- For other tests (Biocompatibility, Physical Properties, Chemotherapy Drug Permeation), specific sample sizes are not detailed in the provided text. However, testing was stated to be "in accordance with the following standards" (ISO and ASTM), which would implicitly define minimum sample sizes for each test method. Data provenance is implied to be from laboratory testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. The tests conducted are laboratory-based and follow established international and national standards (ISO, ASTM). The "ground truth" for these tests is defined by the methodologies and performance requirements within these standards, not by expert consensus in a clinical sense.
4. Adjudication Method for the Test Set:
This information is not applicable as the tests are laboratory performance tests following well-defined standards, not clinical studies requiring independent adjudication of outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable as the device is a medical glove, and the studies are pre-market non-clinical performance and biocompatibility evaluations. It is not an AI-assisted diagnostic device or a device where human reader performance would be a relevant metric.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This information is not applicable as the device is a medical glove, not an algorithm or AI system. The performance evaluated is the physical and chemical resistance of the glove itself.
7. Type of Ground Truth Used:
The ground truth for the evaluations is based on:
- Standardized Laboratory Test Results: Defined by the methodologies and acceptance criteria specified in the referenced ASTM and ISO international standards (e.g., specific tensile strength values, breakthrough times, chemical concentrations).
- Biocompatibility Endpoints: As defined by ISO 10993 standards (e.g., absence of irritation, sensitization, systemic toxicity).
8. Sample Size for the Training Set:
This information is not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
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(76 days)
The Disposable Nitrile Powder-Free Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Disposable Nitrile Powder-Free Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
Based on the provided text, the device in question is "Disposable Nitrile Powder-Free Examination Gloves," which are Class I medical devices used to prevent contamination between patients and examiners. The document describes non-clinical performance testing rather than a study involving human subjects or AI, as would be typical for software or imaging devices.
Therefore, many of the requested categories for AI-based device studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this premarket notification for examination gloves.
Here's the relevant information based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for examination gloves.
Table of Acceptance Criteria and Reported Device Performance for Disposable Nitrile Powder-Free Examination Gloves:
| Test | Methodology / Standard | Purpose | Acceptance Criteria | Reported Performance/Results |
|---|---|---|---|---|
| Biocompatibility | ||||
| Irritation & Skin Sensitization | ISO 10993-10:2010 | Assess possible contact hazards from chemicals, which may produce skin and mucosal irritation, eye irritation or skin sensitization. | Skin Sensitization Test: Provided grades less than 1, otherwise sensitization.Skin Irritation Test: Primary irritation index: 0-0.4 (Negligible), 0.5-1.9 (Slight), 2-4.9 (Moderate), 5-8 (Severe). | Skin Sensitization Test: All grades are 0. All animals survived with no abnormal signs observed.Skin Irritation Test: Primary irritation index is 0. Response categorized as negligible. |
| In Vitro Cytotoxicity | ISO 10993-5:2009 | Assess the in vitro cytotoxicity of medical devices. | Viability reduced to <70% of the blank indicates cytotoxic potential. | Viab.% of 100% test article extract is 21.0%. The proposed device has potential toxicity to L-929 in the MTT method. (Note: Despite this, it was cleared, likely due to subsequent systemic toxicity testing and the nature of glove contact.) |
| Systemic Toxicity | ISO 10993-11:2017 | Evaluate the potential for medical device materials to cause adverse systemic reactions. | Within 72 h, if the toxicosis response of testing group is not greater than that of control group, the testing sample is acceptable. | No evidence of systemic toxicity from the extract. |
| Physical/Performance Properties | ||||
| Residual Powder on Medical Gloves | ASTM D6124-06 (Reapproved 2017) | Determine the amount of residual powder found on medical gloves (for powder-free distinction). | Powder residue limit of 2.0 mg. | 0.09-0.11 mg/glove. (Meets criterion as it is well below 2.0mg) |
| Detection of Holes in Medical Gloves | ASTM D5151-06 (Reapproved 2015) | Cover the detection of holes in medical gloves. | Sample number: 125 gloves. AQL (Acceptable Quality Limit) = 2.5. Criterion ≤7 gloves for water leakage. | No glove water leakage found. |
| Specifications for Nitrile Exam Gloves | ASTM D6319-10 (Reapproved 2015) | Covers certain requirements for nitrile rubber gloves used in medical examinations and procedures. | Dimensions:- S: width 80±10mm, length ≥220 mm- M: width 95±10mm, length ≥230 mm- L: width 110±10mm, length ≥230 mm- XL: width 120±10mm, length ≥230 mmThickness: Finger ≥0.05 mm, Palm ≥0.05 mmPhysical properties:- Before aging: Tensile strength ≥14MPa, Ultimate Elongation ≥500%- After Accelerated Aging: Tensile strength ≥14MPa, Ultimate Elongation ≥400% | Dimensions (across multiple lots):- S: width 82-86 mm, length 245-255 mm- M: width 91-96 mm, length 245-256 mm- L: width 101-110 mm, length 252-261 mm- XL: width 111-120 mm, length 250-262 mm (All reported dimensions meet or exceed the min/range, considering tolerance analyses further down the document).Thickness (across multiple lots): Finger 0.11-0.12 mm, Palm 0.07-0.08 mm (All meet or exceed the minimum).Physical properties (across multiple lots):- Before aging: Tensile strength 15.2-24.4 MPa, Ultimate Elongation 525.655% - 798.544% (All meet or exceed required minimums).- After Accelerated Aging: Tensile strength 14.0-18.7 MPa, Ultimate Elongation 578.552% - 745.388% (All meet or exceed required minimums). |
Study Details (Non-Clinical Performance Testing):
This document describes non-clinical performance testing of a physical device (examination gloves), not a study of an AI algorithm or human reader performance. Therefore, most of the requested fields are not applicable.
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Sample size used for the test set and the data provenance:
- Freedom from Holes: 125 gloves. No specific country of origin is mentioned for the test samples; it's implied they are samples of the manufactured gloves. The testing is prospective as it's part of the product characterization for market submission.
- Other tests (Biocompatibility, Physical properties): Sample sizes are not explicitly stated for individual tests but are implied to be sufficient for compliance with the respective standards (e.g., ISO, ASTM). The data provenance is testing conducted by the manufacturer (Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.) or its contracted labs.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for device performance is established by standardized test methodologies and their objective measurements, not by expert consensus or interpretations.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a human interpretation study.
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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 not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device's performance is defined by adherence to established international and national standards (ASTM, ISO) for material properties, dimensions, and biological safety. This is based on objective measurements and laboratory testing results.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning model. The manufacturing process is implicitly "trained" over time to produce consistent results that meet standards.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI model.
In summary, this FDA 510(k) submission for examination gloves demonstrates substantial equivalence to a predicate device, primarily through non-clinical laboratory testing that shows compliance with relevant performance and safety standards. The regulatory pathway is not driven by AI model validation or human reader performance studies.
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