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510(k) Data Aggregation
(98 days)
The 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.
The device is a disposable examination glove. The subject gloves are made of Synthetic: Nitrile & Polychloroprene. They are non-sterile and intended for Over-The-Counter use.
The provided document is a 510(k) Premarket Notification for medical examination gloves. It details the safety and performance characteristics of "KIMTECH™ PRIZM™ Multi-Layered Exam Glove" and "KIMTECH™ PRIZM™ Xtra Multi-Layered Exam Glove," particularly regarding their resistance to chemotherapy drugs, opioid Fentanyl Citrate, and simulated gastric acid.
Here's an analysis of the acceptance criteria and the study proving the device meets these criteria, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally established standards from ASTM and ISO. The reported device performance is indicated as "Pass" for all tested attributes. Chemical permeation times are specific performance metrics for the glove's resistance to various substances.
Table of Acceptance Criteria and Reported Device Performance
| Attribute / Test Standard | Acceptance Criteria (Standard / Threshold) | Reported Device Performance (KIMTECH™ PRIZM™ / KIMTECH™ PRIZM™ Xtra) |
|---|---|---|
| General Glove Properties | ||
| Common Name | Synthetic Examination Glove | Same (Synthetic Examination Glove) |
| Intended Use | Disposable device for medical purposes to prevent contamination between patient and examiner. | Same |
| Base Material | Synthetic: Nitrile | Similar: Synthetic (Nitrile & Polychloroprene). Considered acceptable as it does not adversely impact safety or performance. |
| Color | NA (Different from predicate, but deemed not to adversely impact safety or performance) | Dark Violet outer surface, Deep Magenta inside surface (Subject gloves) |
| Product Code | LZA, LZC, QDO | Same (LZA, LZC, QDO) |
| Sterile vs. Non-sterile | Non-sterile | Non-sterile |
| Prescription or OTC | OTC | OTC |
| Single Use-Disposable | Yes | Yes |
| Physical Dimensions | ||
| Overall Length (ASTM D6319) | Minimum: 230mm | All sizes comply with length dimensions |
| Overall Width (ASTM D6319) | Minimum: 110 + 10mm | All sizes comply with length dimensions |
| Palm & Finger Thickness (ASTM D6319) | Minimum: Palm: 0.05mm, Finger: 0.05mm | All sizes comply with length dimensions |
| Mechanical Properties | ||
| Tensile Strength: Before & After Aging (ASTM D6319) | Minimum: 14MPa | Complies both before and after accelerated aging |
| Ultimate Elongation: Before & After Aging (ASTM D6319) | Minimum: Before: 500%, After: 400% | Complies both before and after accelerated aging |
| Barrier Integrity | ||
| Freedom from holes (ASTM D6319) | G1, AQL 2.5 (7 Accept, 8 Reject) | Pass |
| Powder Free (ASTM D6319) | Maximum < 2mg/glove | Pass |
| Chemical Resistance (ASTM D6978-05 (2019)) | ||
| KIMTECH™ PRIZM™ Multi-Layered Exam Glove | ||
| Cabazitaxel (60 mg/1.5ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Capecitabine (26 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Carmustine (3.3 mg/ml) | Not explicitly stated, but 47.5 min is reported. Caution statement issued. | 47.5 min (Caution: below 60 min) |
| Cisplatin (1 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Cyclophosphamide (20 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Dacarbazine (10 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Doxorubicin HCL (2 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Eribulin Mesylate (0.5 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Etoposide (20 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Floxuridine (100 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Fluorouracil (50 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Ifosfamide (50 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Lenvatinib (20 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Mitoxantrone (2 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Paclitaxel (6 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Pemetrexed (25 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Sorafenib Tosylate (200 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Tamoxifen (2 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Thiotepa (10 mg/ml) | Not explicitly stated, but 38.2 min is reported. Caution statement issued. | 38.2 min (Caution: below 60 min) |
| Vinblastine Sulfate (1 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Vincristine Sulfate (1 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Vinorelbine (10 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Fentanyl Citrate (100mcg/2mL) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Simulated Gastric Acid (0.2% NaCl in 0.7% HCL) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Fentanyl in Gastric Acid (50/50 mix) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| KIMTECH™ PRIZM™ Xtra Multi-Layered Exam Glove | ||
| Cabazitaxel (60 mg/1.5ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Capecitabine (26 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Carmustine (3.3 mg/ml) | Not explicitly stated, but 37.3 min is reported. Caution statement issued. | 37.3 min (Caution: below 60 min) |
| Cisplatin (1 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Cyclophosphamide (20 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Dacarbazine (10 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Doxorubicin HCL (2 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Eribulin Mesylate (0.5 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Etoposide (20 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Floxuridine (100 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Fluorouracil (50 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Ifosfamide (50 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Lenvatinib (20 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Mitoxantrone (2 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Paclitaxel (6 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Pemetrexed (25 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Sorafenib Tosylate (200 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Tamoxifen (2 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Thiotepa (10 mg/ml) | Not explicitly stated, but 30.1 min is reported. Caution statement issued. | 30.1 min (Caution: below 60 min) |
| Vinblastine Sulfate (1 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Vincristine Sulfate (1 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Vinorelbine (10 mg/ml) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Fentanyl Citrate (100mcg/2mL) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Simulated Gastric Acid (0.2% NaCl in 0.7% HCL) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Fentanyl in Gastric Acid (50/50 mix) | Not explicitly stated as acceptance criteria, but >240 min is performance criterion. | >240 min |
| Biocompatibility | ||
| Systemic Toxicity Test (ISO 10993-11) | Extracts should not elicit a systemic response in the model animal. | Under study conditions, device extracts did not elicit a systemic response in the model animal. |
| Primary Skin Irritation on Rabbits (ISO 10993-10) | Extracts should not be an irritant to the animal model. | Under study conditions, polar and non-polar device extracts were found not to be an irritant to the animal model. |
| Magnusson & Kligman Guinea pig Maximization (ISO 10993-10) | Extracts should not be sensitizers to the animal model. | Under study conditions, polar and non-polar device extracts were found not to be sensitizers to the animal model. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size (number of gloves or test replicates) used for each specific test. It indicates that "Non-Clinical Testing was conducted to demonstrate that the two proposed devices met all required design specifications." The testing appears to follow relevant ASTM and ISO standards, which would typically specify sample sizes.
The data provenance is from non-clinical testing conducted by Kimberly Clark Corporation, based in the United States. The testing is performed for premarket notification, indicating it's prospective data for the purpose of demonstrating substantial equivalence to a legally marketed predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a medical examination glove, and the performance evaluation is based on objective, quantifiable physical and chemical tests (e.g., tensile strength, resistance to chemical permeation, and biocompatibility) against established standards. There is no qualitative assessment or "ground truth" to be established by human experts in the context of diagnostic interpretation.
4. Adjudication method for the test set
This information is not applicable. As stated above, the evaluation relies on objective measurements against engineering and chemical standards, not on human interpretation that would require adjudication.
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 information is not applicable. This is a 510(k) submission for exam gloves, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable, as this is not an AI-powered device.
7. The type of ground truth used
The "ground truth" for evaluating these examination gloves is provided by established international and national standards for medical device performance. Specifically:
- ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D412-2006a: Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- ASTM D573-2004: Standard Test Method for Rubber-Deterioration in an Air Oven
- ASTM D3767-03: Standard Practice for Rubber Measurement of Dimensions
- ASTM D5151-2006: Standard Test Method for Detection of holes in Medical Gloves
- ASTM D6124-2006: Standard Tested Method for Residual Powder on Medical Gloves
- ASTM D6978-05 (Reapproved 2013): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
- ISO 2859: Sampling Procedures and Tables for Inspection by Attributes
- ISO 10993-10: Biological Evaluation of medical Devices-Part 10: Tests for Irritation and Sensitization
- ISO 10993-11: Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
These standards define the methodologies and acceptable limits for various physical, chemical, and biological properties of the gloves.
8. The sample size for the training set
This information is not applicable. The device is a physical product (exam glove), not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of device.
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(30 days)
Kimberly-Clark* U by KOTEX Click* is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid.
This device is a conventional unscented menstrual tampon consisting of an absorbent pledget, overwrap, a withdrawal cord and an applicator. The terminology used in describing the device in rest of the 510(k) submission is as follows; Complete device: U by KOTEX Click* Unscented Menstrual Tampons with applicator Tampon component: Absorbent pledget, overwrap and a withdrawal cord. Applicator: Inner plunger tube, a clear middle telescopic tube and an outer insertion tube (barrel) formed with a closed, rounded tip. The absorbent pledget consists of a ribbon of rayon fibers. A rayon-polyester blend withdrawal cord is placed on the ribbon and the ribbon is radially wound, then compressed into a traditional eight-groove bullet-shaped pledget, overwrapped with a non-woven fabric. The tampon component is inserted into a three-piece plastic applicator consisting of an inner plunger tube, a clear middle telescopic tube and an outer insertion tube (barrel) formed with a closed, rounded tip. Each tampon with applicator is wrapped in an individual plastic film wrapper and packaged in sealed multi-unit containers for retail sale.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Kimberly-Clark* U by KOTEX Click* Unscented Menstrual Tampons, formatted according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Biocompatibility Tests: | |
| Cytotoxicity Test (ISO 10993, Part 5) | Meets |
| Mucosal Irritation Test (ISO 10993, Part 10) | Meets |
| Mucosal Sensitization Test (ISO 10993, Part 10) | Meets |
| Acute Systemic Toxicity Test (ISO 10993, Part 11) | Meets |
| Effectiveness: | |
| Syngyna absorbency requirements (21 CFR § 801.430) | Complies |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set of the preclinical or effectiveness studies. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies listed (e.g., biocompatibility tests, syngyna absorbency) are laboratory-based tests with objective criteria, rather than expert-driven assessments requiring a "ground truth" established by human experts.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are laboratory-based and do not involve human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or implied. The submission is for a modification (new applicator colors) to an already legally marketed device, and the focus is on demonstrating equivalence through preclinical and performance tests, not on improving human reader performance with AI.
6. Standalone (Algorithm Only) Performance Study
This is not applicable as the device is a physical menstrual tampon and not an algorithm or AI-driven system.
7. Type of Ground Truth Used
The "ground truth" for the acceptance criteria mentioned generally refers to:
- Established biological responses/endpoints: For biocompatibility tests (e.g., cell viability for cytotoxicity, inflammatory response for irritation/sensitization, systemic effects for toxicity).
- Standardized physical measurement: For syngyna absorbency, the ground truth is a specific absorbency value determined by the standardized test method outlined in 21 CFR § 801.430.
8. Sample Size for the Training Set
This is not applicable as the device is not an AI/ML algorithm that requires a training set. The existing device (predicate) serves as a basis for substantial equivalence for the modified device.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the reasons stated in point 8.
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