(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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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 30, 2020
Kimberly Clark Corporation % Wava Truscott Consultant Truscott MedSci Associates, LLC 180 Burkemeade Ct Roswell, Georgia 30075
Re: K202416
Trade/Device Name: Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid. Kimtech Prizm Xtra Multi-Lavered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, QDO Dated: November 25, 2020 Received: November 30, 2020
Dear Wava Truscott:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
{1}------------------------------------------------
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809; medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For: Elizabeth F. Claverie, MS Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510(k) Number: K202416
=
Device 1.) Trade Name: KIMTECH™ PRIZM™ Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
| Indications for Use (Describe):CHEMICAL | CONCENTRATION | STANDARD LENGTH |
|---|---|---|
| Cabazitaxel | 60 mg/1.5ml (40,000 ppm) | >240 min. |
| Capecitabine | 26 mg/ml (26,000 ppm) | >240 min. |
| Carmustine | 3.3 mg/ml (3,300 ppm) | 47.5 min. |
| Cisplatin | 1 mg/ml (1,000 ppm) | >240 min. |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | >240 min. |
| Dacarbazine | 10 mg/ml (10,000 ppm) | >240 min. |
| Doxorubicin HCL | 2 mg/ml (2,000 ppm) | >240 min. |
| Eribulin Mesylate | 0.5 mg/ml (500 ppm) | >240 min. |
| Etoposide | 20 mg/ml (20,000 ppm) | >240 min. |
| Floxuridine | 100 mg/ml (100,000 ppm) | >240 min. |
| Fluorouracil | 50 mg/ml (50,000 ppm) | >240 min. |
| Ifosfamide | 50 mg/ml (50,000 ppm) | >240 min. |
| Lenvatinib | 20 mg/ml (20,000 ppm) | >240 min. |
| Mitoxantrone | 2 mg/ml (2,000 ppm) | >240 min. |
| Paclitaxel, | 6 mg/ml (6,000 ppm) | >240 min. |
| Pemetrexed | 25 mg/ml (25,000 ppm) | >240 min. |
| Sorafenib Tosylate | 200 mg/ml (200,000 ppm) | >240 min. |
| Tamoxifen | 2 mg/ml (2,000 ppm) | >240 min. |
| Thiotepa | 10 mg/ml (10,000 ppm) | 38.2 min. |
| Vinblastine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Vinorelbine | 10 mg/ml (10,000 ppm) | >240 min. |
| Fentanyl Citrate | 100mcg/2mL | >240 min. |
| Simulated Gastric Acid | 0.2% (w/v) NaCl in 0.7% (v/v) HCL acid | >240 min. |
| Fentanyl in Gastric Acid | 50/50 mix solution | >240 min. |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X | Over-The-Counter (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED
This section applies only to requirements of the Paperwork Reduction Act of 1995
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFFEMAILADDRESS BELOW®
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number"
Form FDA 3881 (7/17)
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510(k) Number: K202416
Device 2.) Trade Name: KIMTECH™ PRIZM™ Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
| Indications for Use (Describe): | ||
|---|---|---|
| CHEMICAL | CONCENTRATION | XTRA |
| Cabazitaxel | 60 mg/1.5ml (40,000 ppm) | >240 min. |
| Capecitabine | 26 mg/ml (26,000 ppm) | >240 min. |
| Carmustine | 3.3 mg/ml (3,300 ppm) | 37.3 min. |
| Cisplatin | 1 mg/ml (1,000 ppm) | >240 min. |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | >240 min. |
| Dacarbazine | 10 mg/ml (10,000 ppm) | >240 min. |
| Doxorubicin HCL | 2 mg/ml (2,000 ppm) | >240 min. |
| Eribulin Mesylate | 0.5 mg/ml (500 ppm) | >240 min. |
| Etoposide | 20 mg/ml (20,000 ppm) | >240 min. |
| Floxuridine | 100 mg/ml (100,000 ppm) | >240 min. |
| Fluorouracil | 50 mg/ml (50,000 ppm) | >240 min. |
| Ifosfamide | 50 mg/ml (50,000 ppm) | >240 min. |
| Lenvatinib | 20 mg/ml (20,000 ppm) | >240 min. |
| Mitoxantrone | 2 mg/ml (2,000 ppm) | >240 min. |
| Paclitaxel | 6 mg/ml (6,000 ppm) | >240 min. |
| Pemetrexed | 25 mg/ml (25,000 ppm) | >240 min. |
| Sorafenib Tosylate | 200 mg/ml (200,000 ppm) | >240 min. |
| Tamoxifen | 2 mg/ml (2,000 ppm) | >240 min. |
| Thiotepa | 10 mg/ml (10,000 ppm) | 30.1 min. |
| Vinblastine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Vinorelbine | 10 mg/ml (10,000 ppm) | >240 min. |
| Fentanyl Citrate | 100mcg/2mL | >240 min. |
| Simulated Gastric Acid | 0.2% (w/v) NaCl in 0.7% (v/v) HCL acid | >240 min. |
| Fentanyl in Gastric Acid | 50/50 mix solution | >240 min. |
| Caution: Carmustine and Thiotepa have low penetration times of 37.3 min. and 30.1 min. respectively |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X | Over-The-Counter (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED
This section applies only to requirements of the Paperwork Reduction Act of 1995
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFFEMAILADDRESS BELOW
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number'
{4}------------------------------------------------
510(k) Number: K202416
510(k) Summary as required by 807.92(c) FDA Format: Traditional 510k
Preparation Date: November 22, 2020
KIMTECH™ PRIZM™ Multi-Layered Exam Glove Tested for use with Trade Name: Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
KIMTECH™ PRIZMTM Xtra Multi-Layered Exam Glove Tested for use Trade Name: with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
1. Submitter:
| Company Name: | Kimberly-Clark Corporation |
|---|---|
| Address: | 1400 Holcomb Bridge RoadRoswell, GA 30076 |
| Country: | United States |
| General phone: | +1 770-587-8000 |
| Contact Person: | Juan M. MarquezDirector, Regulatory AffairsKimberly-Clark Corporation1400 Holcomb Bridge RoadRoswell, GA 30076 |
| E-mail: | Juan.M.Marquez@kcc.com |
| Phone: | +1 678-352-6069 |
| Fax: | +1 920-969-4863 |
2. Device information:
Device Trade Name: KIMTECH™ PRIZM™ Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
KIMTECH™ PRIZM TM Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
Classification name: Per 21 CFR 807.92(a)2(2): Patient Examination Glove
General Hospital and Personal Use Devices
Synthetic Non-powdered Exam Glove Common name:
Class: Class I (general controls)
Product Codes: LZA, LZC, QDO
{5}------------------------------------------------
Indications for use:
Intended Use: 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.
Testing was performed to determine Break-through times for the Chemotherapy drugs listed below, plus the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid.
Trade Name: KIMTECH™ PRIZM™ Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
KIMTECH™ PRIZM™M Multi-Layered Gloves: ASTM D6978-05 (2019): "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs"
| CHEMICAL | CONCENTRATION | STANDARD Length |
|---|---|---|
| Cabazitaxel | 60 mg/1.5ml (40,000 ppm) | >240 min. |
| Capecitabine | 26 mg/ml (26,000 ppm) | >240 min. |
| Carmustine | 3.3 mg/ml (3,300 ppm) | 47.5 min. |
| Cisplatin, | 1 mg/ml (1,000 ppm) | >240 min. |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | >240 min. |
| Dacarbazine | 10 mg/ml (10,000 ppm) | >240 min. |
| Doxorubicin HCL | 2 mg/ml (2,000 ppm) | >240 min. |
| Eribulin Mesylate | 0.5 mg/ml (500 ppm) | >240 min. |
| Etoposide | 20 mg/ml (20,000 ppm) | >240 min. |
| Floxuridine | 100 mg/ml (100,000 ppm) | >240 min. |
| Fluorouracil | 50 mg/ml (50,000 ppm) | >240 min. |
| Ifosfamide, | 50 mg/ml (50,000 ppm) | >240 min. |
| Lenvatinib | 20 mg/ml (20,000 ppm) | >240 min. |
| Mitoxantrone | 2 mg/ml (2,000 ppm) | >240 min. |
| Paclitaxel, | 6 mg/ml (6,000 ppm) | >240 min. |
| Permetrexed | 25 mg/ml (25,000 ppm) | >240 min. |
| Sorafenib Tosylate | 200 mg/ml (200,000 ppm) | >240 min. |
| Tamoxifen | 2 mg/ml (2,000 ppm) | >240 min. |
| Thiotepa | 10 mg/ml (10,000 ppm) | 38.2 min. |
| Vinblastine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Vinorelbine | 10 mg/ml (10,000 ppm) | >240 min. |
| Fentanyl Citrate | 100mcg/2mL | >240 min. |
| Simulated Gastric Acid | 0.2% (w/v) NaCl in 0.7% (v/v) HCL acid | >240 min. |
| Fentanyl in Gastric Acid | 50/50 mix solution | >240 min. |
| Caution: Carmustine and Thiotepa have low penetration times of 47.5 min. and 38.2 min.respectively |
KIMTECH™ PRIZMTM Multi-Lavered Glove:
Caution: Carmustine and Thiotepa have breakthrough times of less than 60 minutes at 47.5 min. and 38.2 min. respectively
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Indications for use:
Intended Use: 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.
Testing was performed to determine Break-through times for the Chemotherapy drugs listed below, plus the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid.
Trade Name: KIMTECHTM PRIZM TM Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid
| CHEMICAL | CONCENTRATION | Xtra |
|---|---|---|
| Cabazitaxel | 60 mg/1.5ml (40,000 ppm) | >240 min. |
| Capecitabine | 26 mg/ml (26,000 ppm) | >240 min. |
| Carmustine | 3.3 mg/ml (3,300 ppm) | 37.3 min. |
| Cisplatin, | 1 mg/ml (1,000 ppm) | >240 min. |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | >240 min. |
| Dacarbazine | 10 mg/ml (10,000 ppm) | >240 min. |
| Doxorubicin HCL | 2 mg/ml (2,000 ppm) | >240 min. |
| Eribulin Mesylate | 0.5 mg/ml (500 ppm) | >240 min. |
| Etoposide | 20 mg/ml (20,000 ppm) | >240 min. |
| Floxuridine | 100 mg/ml (100,000 ppm) | >240 min. |
| Fluorouracil | 50 mg/ml (50,000 ppm) | >240 min. |
| Ifosfamide, | 50 mg/ml (50,000 ppm) | >240 min. |
| Lenvatinib | 20 mg/ml (20,000 ppm) | >240 min. |
| Mitoxantrone | 2 mg/ml (2,000 ppm) | >240 min. |
| Paclitaxel, | 6 mg/ml (6,000 ppm) | >240 min. |
| Permetrexed | 25 mg/ml (25,000 ppm) | >240 min. |
| Sorafenib Tosylate | 200 mg/ml (200,000 ppm) | >240 min. |
| Tamoxifen | 2 mg/ml (2,000 ppm) | >240 min. |
| Thiotepa | 10 mg/ml (10,000 ppm) | 30.1 min. |
| Vinblastine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Vincristine Sulfate | 1 mg/ml (1,000 ppm) | >240 min. |
| Vinorelbine | 10 mg/ml (10,000 ppm) | >240 min. |
| Fentanyl Citrate | 100mcg/2mL | >240 min. |
| Simulated Gastric Acid | 0.2% (w/v) NaCl in 0.7% (v/v) HCL acid | >240 min. |
| Fentanyl in Gastric Acid | 50/50 mix solution | >240 min. |
| Caution: Carmustine and Thiotepa have low penetration times of 37.3 min. and 30.1 min.respectively |
KIMTECH™ PRIZM™ Xtra Multi-Layered Glove:
Caution: Carmustine and Thiotepa have breakthrough times of less than 60 minutes at 37.3 min. and 30.1 min. respectively
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Subject Gloves Technological Characteristics Comparison Table
Predicate K200072 & K202416 Subject Gloves: Standard & Xtra Length
| Attributes | StandardTest | Predicate Device:K200072 | Subject Glove 1(standard length)K202416 | Subject Glove 2(Xtra-length)K202416 | Comparison |
|---|---|---|---|---|---|
| Common Name | NA | Synthetic ExaminationGlove | SyntheticExaminationGlove | SyntheticExaminationGlove | Same |
| Intended Use | NA | The examination gloveis a disposable deviceintended for medicalpurposes that is wornon the examiner's handor finger to preventcontaminationbetween patient andexaminer. | The examinationglove is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | The examinationglove is a disposabledevice intended formedical purposes thatis worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer. | Same |
| Base Material | NA | Synthetic: Nitrile | Synthetic:Nitrile &Polychloroprene | Synthetic:Nitrile &Polychloroprene | Similar:Predicate andboth Subjectgloves areSyntheticBoth Predicateand Subjectgloves possessnitrileSubject glovesalso havepolychloroprenein theirformulationDoes notadverselyimpact safety orperformance |
| Color | NA | Purple | Dark Violet outersurfaceDeep Magenta insidesurface | Dark Violet outersurfaceDeep Magenta insidesurface | DifferentSubject gloveshave differentinner & outersurface colors.Does notadverselyimpact safety orperformance |
| Product code | NA | LZA, LZC, ODO | LZA, LZC, ODO | LZA, LZC, ODO | Same |
| Attributes | StandardTest | Predicate Device:K200072 | Subject Glove 1(standard length)K202416 | Subject Glove 2(Xtra-length)K202416 | Comparison |
| Sterile vs. non-sterile | NA | Non-sterile | Non-sterile | Non-sterile | Same |
| Prescription orOTC | NA | OTC | OTC | OTC | Same |
| Single Use-Disposable | NA | Yes | Yes | Yes | Same |
| Indications foruse (summary) | ASTMD1678-05 | Glove was Testedfor use withchemotherapydrugs, the OpioidFentanyl Citrate,simulated Gastricacid, and Fentanylin Gastric Acid | Glove was Tested foruse withchemotherapy drugs,the Opioid FentanylCitrate, simulatedGastric acid, andFentanyl in GastricAcid | Glove was Tested foruse withchemotherapy drugs,the Opioid FentanylCitrate, simulatedGastric acid, andFentanyl in GastricAcid | Same:Test MethodSame:FentanylCitrate,simulatedGastric Acidand Fentanyl inGastric AcidSimilar:ChemotherapyChemicalstested(see below) |
| ChemicalsTested | ASTMD1678-05 | Chemotherapydrugs tested:Carmustine(BCNU)Cisplatin,Cyclophosphamide(Cytoxan),Dacarbazine(DTIC)DoxorubicinHydrochloride,Etoposide(Toposar)Fluorouracil,MethotrexatePaclitaxel (Taxol),ThiotepaVincristine Sulfate | Chemotherapydrugs tested:CabazitaxelCapecitabineCarmustineCisplatin,CyclophosphamideDacarbazineDoxorubicin HCLEribulin MesylateEtoposideFloxuridineFluorouracilIfosfamide,LenvatinibMitoxantronePaclitaxel,PermetrexedSorafenib TosylateTamoxifenThiotepaVinblastine SulfateVincristine SulfateVinorelbine | Chemotherapydrugs tested:CabazitaxelCapecitabineCarmustineCisplatin,CyclophosphamideDacarbazineDoxorubicin HCLEribulin MesylateEtoposideFloxuridineFluorouracilIfosfamide,LenvatinibMitoxantronePaclitaxel,PermetrexedSorafenib TosylateTamoxifenThiotepaVinblastine SulfateVincristine SulfateVinorelbine | Similar:Somechemotherapydrugs aredifferent |
| Attributes | StandardTest | Predicate Device:K200072 | Subject Glove 1(standard length)K202416 | Subject Glove 2(Xtra-length)K202416 | Comparison |
| Caution/WarningStatements | NA | In Addition: FentanylCitrate simulatedGastric Acid,Fentanyl in GastricAcidNote: Carmustineand Thiotepa haveextremely lowpermeation timesof 3.6 &15.9 min.respectively.WARNING: DoNot Use With:Carmustine,Thiotepa | In Addition: FentanylCitrate simulatedGastric Acid,Fentanyl in GastricAcidCaution:Carmustine andThiotepa have lowpermeation timesbelow 60minutes at 47.5min and 38.2 min.respectively | In Addition: FentanylCitrate simulatedGastric Acid,Fentanyl in GastricAcidCaution:Carmustine andThiotepa have lowpermeation timesbelow 60minutes at 37.3min and 30.1 min.respectively | DifferentThe predicatehas a Warningwhile bothSubject Glove 1and 2 haveCautionstatement |
| Dimensions:Overall Length | ASTM D6319Minimum:230mm | All sizes comply withlength dimensions | All sizes comply withlength dimensions | All sizes comply withlength dimensions | Same |
| Dimensions:Overall Width | ASTM D6319Minimum: 110+ 10mm | All sizes comply withlength dimensions | All sizes comply withlength dimensions | All sizes comply withlength dimensions | Same |
| Dimensions:Palm &FingerThickness | ASTM D6319Minimum:Palm: 0.05mmFinger:0.05mm | All sizes comply withlength dimensions | All sizes comply withlength dimensions | All sizes comply withlength dimensions | Same |
| Tensilestrength:Before & AfterAging | ASTM D6319MinimumBefore: 14MPaAfter: 14MPa | Complies bothbefore and afteraccelerated aging | Complies bothbefore and afteraccelerated aging | Complies bothbefore and afteraccelerated aging | Same |
| UltimateelongationBefore &After aging | ASTM D6319Minimum:Before: 500%After:400% | Complies both beforeand after acceleratedaging | Complies both beforeand after acceleratedaging | Complies both beforeand after acceleratedaging | Same |
| Attributes | Standard Test | Predicate Device:K200072 | Subject Glove 1(standard length)K202416 | Subject Glove 2(Xtra-length)K202416 | Comparison |
| Freedom from holes | ASTM D6319G1,AQL 2.57 Accept8 Reject | Pass | Pass | Pass | Same |
| Powder Free | ASTM 6319Maximum<2mg/glove | Pass | Pass | Pass | Same |
| Bio-compatibility | ISO 10993-11Systemic Toxicity Test | Under conditions of the study, the device extracts did not elicit a systemic response in the model animal. | Under conditions of the study, the device extracts did not elicit a systemic response in the model animal. | Under conditions of the study, the device extracts did not elicit a systemic response in the model animal. | Same |
| ISO 10993-10Primary Skin Irritation on Rabbits | Under Conditions of this study, the polar and non-polar device extracts were found not to be an irritant to the animal model. | Under Conditions of this study, the polar and non-polar device extracts were found not to be an irritant to the animal model. | Under Conditions of this study, the polar and non-polar device extracts were found not to be an irritant to the animal model. | Same | |
| ISO 10993-10Magnusson & KligmanGuinea pig Maximization | Under Conditions of this study, the polar and non-polar device extracts were found not to be sensitizers to the animal model. | Under Conditions of this study, the polar and non-polar device extracts were found not to be sensitizers to the animal model. | Under Conditions of this study, the polar and non-polar device extracts were found not to be sensitizers to the animal model. | Same |
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Non-Clinical Testing was conducted to demonstrate that the two proposed devices met all required design specifications. The test results demonstrated that the proposed devices did meet the performance criteria as specified utilizing the following test method standards and specifications:
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| Summary of Non-Clinical Performance Tests | |
|---|---|
| ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for MedicalApplication | Pass |
| ASTM D412-2006a (Reapproved 2013) Standard Test Method for VulcanizedRubber and Thermoplastic Elastomers-Tension | Pass |
| ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber-Deterioration in an Air Oven | Pass |
| ASTM D3767-03 Standard Practice for Rubber Measurement of Dimensions | Pass |
| ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of holes inMedical Gloves | Pass |
| ASTM D6124-2006 (Reapproved 2015) Standard Tested Method for Residual Powder onMedical Gloves | Pass |
| ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Resistance ofMedical Gloves to Permeation by Chemotherapy Drugs | Pass |
| ISO 2859 Sampling Procedures and Tables for Inspection by Attributes | Pass |
| ISO 10993-10 Biological Evaluation of medical Devices-Part 10: Tests for Irritation andSensitization | Pass |
| ISO 10993-11 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity | Pass |
Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the subject devices are as safe, as effective, and performs as well as or better than the legally marketed device.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.