(103 days)
The nitrile powder free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are dark magenta in color, and are single use only, non-sterile, disposable gloves. The powder-free gloves are made of synthetic copolymers of acrylonitrile and butadiene. The product will be sold as a disposable and non-sterile product in extrasmall, small, medium, large, and extra-large sizes.
The provided text describes the acceptance criteria and study results for "KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid." This is a medical device, specifically examination gloves, and the acceptance criteria and studies are related to its physical properties, biocompatibility, and resistance to permeation by certain chemicals.
Here's an analysis based on your request:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard Where Limits Test Limits Set) | Reported Device Performance (Results) |
|---|---|
| Dimensions (ASTM D 6319) | Meets Requirements |
| Length: 220 mm minimum (XS, S), 230 mm minimum (M, L, XL) | All sizes comply with length dimensions |
| Width (mean): 70 mm minimum (XS), 80 mm minimum (S), 95 mm minimum (M), 110 mm minimum (L), 120 mm minimum (XL) | All sizes comply with width dimensions |
| Finger Thickness: 0.05 mm minimum | All sizes comply with Finger Thickness dimensions |
| Palm Thickness: 0.05 mm minimum | All sizes comply with Palm Thickness dimensions |
| Physical Properties (ASTM D 6319) | Meets Requirements |
| Before Aging: Tensile Strength: ≥ 14 MPa, Ultimate elongation: ≥ 500% | Complies both before and after accelerated aging |
| After Aging: Tensile Strength: ≥ 14 MPa, Ultimate elongation: 400% | Complies both before and after accelerated aging |
| Freedom from Pinholes (ASTM D 5151) | Meets Requirements |
| AQL 2.5, No leakage | Pass (AQL 0.65) - Note: Subject device has a tighter AQL than the predicate |
| Powder-Free (ASTM D 6124) | Meets Requirements |
| ≤ 2 mg / glove | Passed at <2mg / glove in accordance with the standard |
| Biocompatibility (ISO 10993) | |
| Irritation (ISO 10993, Part 23): No irritation | Under the conditions of the study, the device is not an irritant. |
| Acute Systemic Toxicity (ISO 10993, Part 11): No systemic toxicity | No evidence of Acute systemic toxicity |
| Dermal Sensitization (ISO 10993, Part 10): No sensitization | Under the conditions of the study, the device is not a sensitizer |
| Resistance to Permeation by Chemotherapy Drugs (ASTM D6978-05) | |
| No signs of breakthrough for the subject device up to 240 minutes. Any drugs performing at less than 240 minutes are specified as such. | Breakthrough was measured for up to 240 minutes for each of the 24 chemotherapy drugs and opioid drug listed. See Table 5.2 for specific breakthrough detection times. (e.g., Carmustine: 78.1 min, others >240 min) |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the exact sample sizes used for each specific test (e.g., how many gloves were tested for pinholes, or how many individual permeation tests were conducted for each chemical). However, it references recognized standards like ASTM D6319 (for dimensions and physical properties, which dictates sampling plans), ASTM D5151 (for holes, which specifies AQLs), and ISO 2859-1:1999 (Sampling Procedures and Tables for Inspection by Attributes). Meeting these AQLs (Acceptable Quality Levels) implies specific sample sizes would have been drawn and tested in accordance with the standards.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, given it's an FDA 510(k) submission, the studies would have been conducted by the manufacturer (Kimberly-Clark Corporation) or their designated testing facilities, likely in a controlled, prospective manner to generate data for the submission. The testing standards are international (ASTM, ISO), suggesting globally recognized methods.
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 to this type of device and study. The testing described involves objective, quantitative measurements of physical and chemical resistance properties according to established engineering and material science standards (ASTM, ISO). "Ground truth" in this context is defined by the objective measurement procedures and acceptance criteria outlined in these standards, not by expert consensus or interpretation of images/clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable. Adjudication methods like 2+1 or 3+1 refer to processes for resolving disagreements among multiple human readers in diagnostic imaging or clinical studies. The studies presented here are laboratory-based, objective material property 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:
This is not applicable. This submission is for a physical medical device (examination gloves), not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. As stated above, this is not an AI algorithm. The performance described is inherent to the physical glove material and construction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established by objective, quantitative measurements conducted in a laboratory setting according to internationally recognized standards and test methods. For example:
- Dimensions: Measured directly using calibrated instruments.
- Tensile Strength & Elongation: Measured using universal testing machines as per ASTM standards.
- Freedom from Pinholes: Determined by water leak tests following ASTM D5151.
- Powder Content: Measured gravimetrically as per ASTM D6124.
- Biocompatibility: Determined by laboratory animal studies (e.g., skin irritation, sensitization, systemic toxicity) following ISO 10993 guidelines, which define the biological response.
- Permeation Resistance: Measured by quantifying breakthrough time of specific chemicals using analytical techniques (e.g., chromatography) as per ASTM D6978-05.
8. The sample size for the training set:
This is not applicable. These studies are for a physical product validation, not for training an AI or machine learning model. There is no "training set" in this context.
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 validation.
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August 28, 2023
Kimberly-Clark Corporation % Amy Fowler Consultant Pathmaker FDA Law PLLC 1415 Lilac Drive N, Suite 270 Minneapolis, Minnesota 55422
Re: K231435
Trade/Device Name: KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO, OPJ Dated: May 17, 2023 Received: May 17, 2023
Dear Amy Fowler:
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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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); 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.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. 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
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Indications for Use
510(k) Number (if known)
K231435
Device Name
KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
Indications for Use (Describe)
The nitrile powder free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
Table 1. Chemotherapy Drugs, Concentrations, and Minimum Breakthrough Detection Times
| Chemotherapy Drug | Concentration | Minimum BreakthroughDetection Time |
|---|---|---|
| Avastin | 25 mg/mL (25,000 ppm) | >240 min. |
| 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) | 78.1 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. |
| Oxaliplatin | 5 mg/mL (5,000 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) | >240 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. |
Caution: The following chemotherapy drug has low permeation (3.3mg/ml): 78.1 minutes.
Tested in accordance to ASTM D6978-05 (2019)
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Indications for Use
510(k) Number (if known)
K231435
Table 2. Fentanyl Citrate, Simulated Gastric Acid, and Simulated Gastric Acid with Fentanyl Citrate Mix Minimum Breakthrough Detection Times
| Fentanyl/Gastric Acid | Concentration | Minimum BreakthroughDetection Time |
|---|---|---|
| Fentanyl Citrate | 100mcg/2mL | >240 min. |
| Simulated Gastric Acid Fluid | 0.2% (w/v) NaCl in 0.7% (v/v) HCl acid | >240 min. |
| Simulated Gastric Acid Fluid/FentanylCitrate Injection Mix | 50/50 mix solution | >240 min. |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (K231435) (As required by 21 CFR 807.92)
1. Submission Information
KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
| Date Prepared: | <august 2023="" 28,=""> |
|---|---|
| Submission Format: | Traditional 510(k) |
| 510(k) #: | K231435 |
2. Submitter Information
| Applicant: | Kimberly-Clark Corporation |
|---|---|
| Address: | 1400 Holcomb Bridge RoadRoswell, Georgia 30076 |
| Phone: | +1 770 587 8000 |
| Contact person: | Kimberly TempasAssociate Director, Regulatory Affairs |
| 2100 Winchester RoadNeenah, WI 54956 | |
| Phone:Email: | +1 (920) 721-4084Kimberly.Tempas@kcc.com |
3. Device Information
| Trade Name: | KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam GlovesTested for Use with Chemotherapy Drugs, Opioid FentanylCitrate, Simulated Gastric Acid and Fentanyl in SimulatedGastric Acid |
|---|---|
| Common Name: | Nitrile powder-free patient exam glove for use withchemotherapy drugs and fentanyl |
| Classification Name: | Non-powered Patient Examination Glove |
| Regulation: | 21 CFR 880.6250 |
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| Regulatory Class: | Class I |
|---|---|
| Panel: | General Hospital |
| Product Codes: | LZA, LZC, QDO, OPJ |
| Product codes | |
|---|---|
| LZA | Polymer Patient Examination Glove |
| LZC | Patient Examination Glove, Specialty |
| QDO | Fentanyl and other opioid protection gloves |
| OPJ | Medical Gloves with Chemotherapy Labeling Claims |
| Table 5.1. Product codes | ||
|---|---|---|
| -------------------------- | -- | -- |
4. Predicate Device Information
K200072 Powder-free Nitrile Exam Glove for use with Chemotherapy drugs and Fentanyl Product Code: LZC, LZA, QDO.
5. Device Description
KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are dark magenta in color, and are single use only, non-sterile, disposable gloves. The powder-free gloves are made of synthetic copolymers of acrylonitrile and butadiene. The product will be sold as a disposable and non-sterile product in extrasmall, small, medium, large, and extra-large sizes.
6. Indications for Use
The nitrile powder-free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
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| Chemotherapy Drug | Concentration | Minimum BreakthroughDetection Time |
|---|---|---|
| Avastin | 25 mg/mL (25,000 ppm) | >240 min. |
| 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) | 78.1 minutes |
| 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. |
| Oxaliplatin | 5 mg/mL (5,000 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) | >240 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/Gastric Acid | Concentration | Minimum BreakthroughDetection Time |
| Fentanyl Citrate | 100mcg/2mL | >240 min. |
| Simulated Gastric Acid Fluid | 0.2% (w/v) NaCl in 0.7% (v/v) HCLacid | >240 min. |
| Simulated Gastric AcidFluid/Fentanyl Citrate InjectionMix | 50/50 mix solution | >240 min. |
Table 5.2. Permeation Times for Chemotherapy Drugs
Caution: The following chemotherapy drug has a low permeation time: Carmustine (3.3mg/ml): 78.1 minutes.
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7. Predicate & Subject Technological Characteristics Comparison Table
| Attributes | Standard WhereLimits Test LimitsSet | PurpleK200072(Predicate) | Polaris(Subject Device) | Comparison |
|---|---|---|---|---|
| DeviceRegulation | NA | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| ProductCodes | NA | LZA, LZC, QDO | LZA, LZC, QDO,ОРЈ | Same |
| CommonName | NA | Examination glove | Examinationglove | Same |
| Sizes | NA | Five sizes:XS, S, M, L, XL | Five sizes:XS, S, M, L, XL | Same |
| BaseMaterial | NA | Nitrile | Nitrile | Same |
| Color | NA | Purple | Dark Magenta | Similar:Biocompatibility& physicalattributes testingshow that thedifference incolor does notalter glovesafety orperformance. |
| Gloveformulation | NA | KC Purple Nitrile9.5 ChemoFormulation | Proprietaryformula | Similar:Formulationsshare similarmaterials andphysicalcharacteristics;biocompatibilityand physicalpropertiestesting show thatthe subjectdevice'sformulation doesnot reduce glovesafety orperformance. |
| Attributes | Standard WhereLimits Test Limits Set | PurpleK200072(Predicate) | Polaris(Subject Device) | Comparison |
| Glove layers | NA | Single layer | Single layer | Same |
| Sterile orNon- Sterile | NA | Non-Sterile | Non-Sterile | Same |
| Prescriptionor OTC | NA | ОТС | ОТС | Same |
| Single UseDisposable | NA | Yes | Yes | Same |
| Intended Use/Indications forUse | NA | The device is adisposable deviceintended for medicalpurposes that isworn on theexaminer's hand orfinger to preventcontaminationbetween patientsand examiner.KIMTECH™ PurpleNitrile™ Powder freeExamination Glovesare Tested for Usewith ChemotherapyDrugs, OpioidFentanyl Citrate,Simulated GastricAcid, and Fentanyl inSimulated GastricAcid. | The nitrilepowder-freepatientexaminationglove is a non-sterile disposabledevice intendedfor medicalpurposes that isworn on theexaminer's handto preventcontaminationbetween patientand examiner.In addition toroutineexaminationglove's intendeduse, the glovesare tested forUse withChemotherapyDrugs, OpioidFentanyl Citrate,SimulatedGastric Acid andFentanyl inSimulatedGastric Acid. | Similar:The subjectdevice removed"or finger"because it isintended to beworn on thehand, not thefinger. |
| Attributes | Standard WhereLimits Test LimitsSet | PurpleK200072(Predicate) | Polaris(Subject Device) | Comparison |
| Indicationsfor UseClaims: | Chemotherapydrugs tested forpermeation anddegradation inaccordance withASTM D6978-05(2019) | ChemotherapyDrugs Tested:1. Carmustine2. Cyclophosphamide3. Doxorubicin HCL4. Etoposide5. Fluorouracil6. Mitoxantrone7. Paclitaxel8. ThioTEPA9. Dacarbazine10. Ifosfamide11. VincristineSulfate12. Bleomycin Sulfate13. Busulfan14. Cytarabine15. Dacarbazine16. Daunorubicin17. Docetaxel18. Epirubicin19. Fludarabine20. Gemcitabine21. Idarubicin22. MechlorethamineHCL23. Melphalan24. Methotrexate25. Mitomycin C26. Osplaten27. Paraplatin28. Rituximab | ChemotherapyDrugs Tested:1. Avastin2. Cabazitaxel3. Capecitabine4. Carmustine5. Cisplatin6. Cyclophosphamide7. Dacarbazine8. DoxorubicinHCL9. EribulinMesylate10. Etoposide11. Floxuridine12. Fluorouracil13. Ifosfamide14. Lenvatinib15. Mitoxantrone16. Oxaliplatin17. Paclitaxel18. Pemetrexed19. SorafenibTosylate20. Tamoxifen21. ThioTEPA22. VinblastineSulfate23. VincristineSulfate24. Vinorelbine | Similar: Bothhave beentested with acommon listofchemotherapydrugs inaccordancewith the sametest method,but thesubject glovehas beentested forsome differentchemotherapydrugs tobetter meetcurrent userandchemotherapytreatmentneeds. |
| Attributes | Standard WhereLimits Test Limits Set | PurpleK200072(Predicate) | Polaris(Subject Device) | Comparison |
| Permeation andDegradation Testsof OtherSubstances | ASTM D6978-05(2019) | Passed permeationtesting for:Fentanyl citrateSimulated gastric acid50/50 mix of fentanyland gastric acid | Passed permeationtesting for:Fentanyl citrateSimulated gastric acid50/50 mix of fentanyland gastric acid | Same |
| Carmustine andThioTEPAPermeation Time | ASTM D6978-05(2019) | Carmustine: 3.6minutesThioTEPA: 15.9minutes | Carmustine: 78.1minutesThioTEPA: >240minutes | Different: The predicatewas below minimumpermeation time of 240minutes specified in thestandard for Carmustineand ThioTEPA while thesubject device is onlybelow the minimumpermeation time of 240minutes specified in thestandard forCarmustine. |
| Carmustine andThioTEPACaution/ WarningStatements | NA | WARNING: Not foruse with:Carmustine,ThioTEPA | Caution: The followingchemotherapy drug hasa low permeation time:Carmustine(3.3mg/ml): 78.1minutes | Different: The predicatehas a warning due toextremely lowpermeation times whilethe subject device haslesser "CautionStatement" based onpermeation times >70minutes. |
| Dimensions:Overall Length | ASTM D6319Minimum: 230 mm | All sizes comply withlength dimensions | All sizes comply withlength dimensions | Same |
| Dimensions: Width(mean) | ASTM D6319Minimum: 70 +10mm | All sizes comply withwidth dimensions | All sizes comply withwidth dimensions | Same |
| Dimensions: Palm& Finger Thickness | ASTM D6319Minimum Palm:0.05mmMinimum Finger:0.05mm | All sizes comply withPalm & FingerThickness dimensions | All sizes comply withPalm & FingerThickness dimensions | Same |
| Attributes | Standard WhereLimits Test LimitsSet | PurpleK200072(Predicate) | Polaris(Subject Device) | Comparison |
| TensileStrength:Before & AfterAging | ASTM D6319Min Before: 14MPaAfter: 14Mpa | Complies bothbefore and afteraccelerated aging. | Complies bothbefore and afteraccelerated aging. | Same |
| UltimateElongationBefore & Afteraging | ASTM D6319Minimum: Before:500%After:400% | Complies both beforeand after acceleratedaging. | Complies bothbefore and afteraccelerated aging. | Same |
| Freedom fromPinholes | ASTM D6319 G1,AQL 2.57 Accept8 Reject | Pass(AQL 1.5) | Pass(AQL 0.65) | Same: Bothgloves passthe tests.The subjectglove AQL istighter andallows fewerpinholedefects. |
| Powder-Free | ASTM D6319-19(2019) Maximum<2mg/glove | Passed at <2mg /glove in accordancewith the standard | Passed at <2mg /glove inaccordance withthe standard | Same |
| BiocompatibilityAcute SystemicToxicity | ISO 10993-11:2017(E) —Biologicalevaluation ofmedical devices -Part 11: Tests forsystemic toxicity | Pass | Pass | Same |
| BiocompatibilitySkin Irritation | ANSI/AAMI/ISO10993-23:2021(E) -Biologicalevaluation ofmedical devices -Part 23: Tests forirritation | Pass | Pass | Same |
| Attributes | Standard WhereLimits Test LimitsSet | PurpleK200072(Predicate) | Polaris(Subject Device) | Comparison |
| BiocompatibilitySkinSensitization | ISO 10993-23:2021(E) —Biologicalevaluation ofmedical devices –Part 10: Tests forskin sensitization | Pass | Pass | Same |
Table 5.3. Comparison between Subject and Predicate Devices
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9. Summary of Non-Clinical Performance Tests:
The subject 510(k) device has undergone a series of safety and performance tests. The test results demonstrated that the proposed device met the performance criteria as specified utilizing the following test methods, standards, and specifications:
- . ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application (FDA Recognition number 6-446)
- . ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves (FDA Recognition number 6-424)
- . ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves (FDA Recognition number 6-178)
- . ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (FDA Recognition number 6-147)
- . ISO 2859-1:1999 Sampling Procedures and Tables for Inspection by Attributes. (FDA Recognition number 5-88)
- . ASTM D412-2006a (Reapproved 2013) Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension (FDA Recognition number 8-596)
- . ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber-Deterioration in an Air Oven (No FDA Recognition number)
- ASTM D3767-03 (2020) Standard Practice for Rubber Measurement of Dimensions (No FDA Recognition number)
- . ASTM D7103-19 Standard guide for assessment of medical gloves (FDA Recognition number 6-444)
- . ANSI/AAMI/ISO 10993-23:2021(E) - Biological evaluation of medical devices -Part 23: Tests for irritation (FDA Recognition number 2-291)
- . ANSI/AAMI/ISO 10993-10:2021(E)- Biological evaluation of medical devices -Part 10: Tests for skin sensitization (FDA Recognition number 2-296)
- . ANSI/AAMI/ISO 10993-11:2017(E) – Biological evaluation of medical devices – Part 11: Tests for systemic toxicity. (FDA Recognition number 2-255)
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- ANSI/AAMI/ISO 10993-12:2021(E) Biological evaluation of medical devices Part 12: Sample preparation and reference material. (FDA Recognition number 2-289)
- ANSI/AAMI/ISO 10993-2:2022(E) Biological evaluation of medical devices -Part 2: Animal welfare requirements (FDA Recognition number 2-222)
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| Brief descriptionof non-clinicaltests: | Test | Standard | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimensions | ASTM D 6319 | MeetsRequirements | ||
| Length | 220 mm minimum(XS, S)230 mm minimum(M, L, XL) | |||
| Width (mean) | 70 mm minimum (XS)80 mm minimum (S)95 mm minimum (M)110 mm minimum (L)120 mm minimum(XL) | |||
| Finger ThicknessPalm Thickness | 0.05 mm minimum0.05 mm minimum | |||
| Physical Properties | ASTM D 6319 | AQL 4 | MeetsRequirements | |
| BeforeTensile Strength: $\geq$ 14 MPaUltimate elongation: $\geq$ 500%AfterTensile Strength: $\geq$ 14 MPaUltimate elongation:400% | ||||
| Freedom fromPinholes | ASTM D 5151 | AQL 2.5No leakage | MeetsRequirements | |
| Power - Free | ASTM D 6124 | $\leq$ 2 mg / glove | MeetsRequirements | |
| ISOIrritationStudy | ISO 10993, Part 23 | No irritation | Under theconditions ofthe study thedevice is not anirritant. | |
| ISO Acute Systemic | ISO 10993, Part 11 | No systemic toxicity | No evidence of | |
| ToxicityStudy | Acute systemictoxicity | |||
| ISO DermalSensitization | ISO 10993, Part 10 | No sensitization | Under theconditionsof the study thedevice is not asensitizer | |
| Standard PracticeforAssessment ofResistance ofMedicalGloves toPermeationby ChemotherapyDrugs | ASTM D6978-05 | No signs ofbreakthrough for thesubject device up to240 minutes. Anydrugs performing atless than 240 minutesare specified as such.Refer to Table 5.2 forMinimumbreakthroughdetection times | Breakthrough wasmeasuredfor up to 240minutes for eachof the 24chemotherapydrugs and opioiddrug listed above.Refer to Table 5.2for minimumbreakthroughdetection times. |
Table 5.4 Description of Non-Clinical Tests
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- Summary of Clinical Performance Testing: Not applicable.
11. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that, the KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid, is as safe, as effective, and performs as well as or better than the predicate device, the KIMTECH™ Purple Nitrile Powder-Free Exam Glove cleared in K200072.
§ 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.