(102 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™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are 245mm in length and 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 document describes the safety and performance testing of KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves. However, this is a 510(k) premarket notification for a medical glove, not an AI/ML medical device. Therefore, the information required to answer the specific questions about acceptance criteria for an AI/ML device, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, or clinical study design (MRMC), is not present in this document.
The document focuses on non-clinical performance tests of the physical and chemical properties of the gloves.
Here's an attempt to extract relevant "acceptance criteria" and "reported performance" based on the provided document, framed as close as possible to the request, while highlighting the limitations for an AI/ML context.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is for a physical medical device (gloves), the "acceptance criteria" are defined by recognized standards (e.g., ASTM, ISO) for physical properties, chemical resistance, and biocompatibility.
| Test Category | Acceptance Criteria (from Standards) | Reported Device Performance (KIMTECH™ Polaris™ Nitrile Gloves) |
|---|---|---|
| Dimensions | Length: ≥ 230 mmWidth (mean): ≥ 70 mmFinger/Palm Thickness: ≥ 0.05 mm | Meets requirements (All sizes comply with length, width, and thickness dimensions) |
| Physical Properties | Before Aging:Tensile Strength: ≥ 14 MPaUltimate Elongation: ≥ 500%After Aging:Tensile Strength: ≥ 14 MPaUltimate Elongation: ≥ 400% | Meets requirements (Complies both before and after accelerated aging) |
| Freedom from Pinholes | ASTM D6319 G1, AQL 2.5 (7 Accept, 8 Reject)No leakage | Pass (AQL 0.65) - Note: Subject glove AQL is tighter than the standard, indicating better performance. |
| Powder-Free | ≤ 2 mg / glove | Passed at < 2mg / glove in accordance with the standard |
| Biocompatibility - Irritation | Primary Irritation Index ≤ 0.4 (ISO 10993, Part 23) | Under the conditions of the study, the device is not an irritant (Passed) |
| Biocompatibility - Systemic Toxicity | No animals treated with test extracts exhibit greater reaction than control animals (ISO 10993, Part 11) | No evidence of Acute systemic toxicity (Passed) |
| Biocompatibility - Skin Sensitization | Grade < 1 (ISO 10993, Part 10) | Under the conditions of the study, the device is not a sensitizer (Passed) |
| Chemotherapy Drug Permeation | No signs of breakthrough up to 240 minutes for most drugs (ASTM D6978-05). Drugs with lower permeation times must be specified. | Breakthrough measured for up to 240 minutes for most of the 24 chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl in Simulated Gastric Acid. Exceptions: - Carmustine: 76.6 minutes - ThioTEPA: 78.5 minutes (both less than 240 min, and subject to caution statements) |
The following information typically required for an AI/ML device is NOT found in this document because it describes a physical medical glove:
- Sample size used for the test set and the data provenance: Not applicable. For gloves, testing involves physical samples tested according to standards. The document lists the ASTM and ISO standards used for testing the gloves. There's no "test set" of data in the AI/ML sense. Data provenance would refer to the origin of the physical glove samples tested.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties and chemical resistance is established by laboratory measurements against defined standards, not human expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept pertains to human interpretation/labeling of data in AI/ML studies.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is strictly for AI/ML performance studies involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" equates to the results of standardized, objective laboratory tests for physical and chemical properties (e.g., tensile strength, resistance to permeation, absence of pinholes, etc.) and biocompatibility studies.
- The sample size for the training set: Not applicable. This device does not use an AI/ML model that requires training data.
- How the ground truth for the training set was established: Not applicable. No training set is used.
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July 21, 2023
Kimberly-Clark Corporation % Amy Fowler Consultant Pathmaker FDA Law, P.L.L.C. 1415 Lilac Drive N; Suite 270 Minneapolis, Minnesota 55422
Re: K231021
Trade/Device Name: KIMTECH™ Polaris™ 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, OPJ, QDO Dated: April 10, 2023 Received: April 10, 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.
Allan Guan -S
For 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
Enclosure
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Indications for Use
510(k) Number (if known)
K231021
Device Name
KIMTECH™ Polaris™ 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.
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) | 76.6 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 | 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) | 78.5 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. |
Table continued page 2-2.
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Indications for Use
510(k) Number (if known)
K231021
Device Name
KIMTECH™ Polaris™ 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.
Non-Chemotherapy Drugs, Concentrations, and Minimum Breakthrough Detection Times, continued
| 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. |
Caution: The following chemotherapy drugs have low permeation (3.3mg/ml): 76.6 minutes and ThioTEPA (10 mg/ml): 78.5 minutes respectively.
| Type of Use (Select one or both, as applicable) | |
|---|---|
_ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
K231021
1. Submission Information
| Date Prepared: | <July 7th, 2023> |
|---|---|
| Submission Format: | Traditional 510(k) |
| 510(k) #: | K231021 |
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: | +1 (920) 721-4084 |
| Email: | Kimberly. Tempas@kcc.com |
3. Device Information
| Trade Name: | KIMTECH™ Polaris™ 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: | Patient Examination Glove |
| Regulation: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
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| 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 |
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™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are 245mm in length and 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) | 76.6 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 | 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) | 78.5 minutes |
| 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) HCL acid | >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 drugs have low permeation times: Carmustine (3.3mg/ml): 76.6 minutes and ThioTEPA (10 mg/ml): 78.5 minutes respectively.
- Predicate & Subject Technological Characteristics Comparison Table
Table 5.3. Comparison between Subject and Predicate Devices
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| 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, OPJ | 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. |
| Glove layers | NA | Single layer | Single layer | Same |
| Sterile orNon- Sterile | NA | Non-Sterile | Non-Sterile | Same |
| Prescriptionor OTC | NA | OTC | OTC | Same |
| Single UseDisposable | NA | Yes | Yes | Same |
| IntendedUse/indications for use | NA | The device is adisposable deviceintended formedical purposesthat is worn on theexaminer's hand orfinger to preventcontaminationbetween patientsand examiner.KIMTECHTM PurpleNitrileTM 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 list ofchemotherapydrugs inaccordancewith the sametest method,but the subjectglove has beentested for somedifferentchemotherapydrugs to bettermeet currentuser andchemotherapytreatmentneeds. |
| Attributes | Standard WhereLimits TestLimits Set | PurpleK200072(Predicate) | Polaris(Subject Device) | Comparison |
| Permeationanddegradationtests ofothersubstances | ASTM D6978-05(2019) | Passed permeationtesting for:Fentanyl citrateSimulated gastric acid50/50 mix of fentanyland gastric acid | Passed permeationtesting for:Fentanyl citrateSimulated gastricacid50/50 mix offentanyl and gastricacid | Same |
| CarmustineandThioTEPAPermeationtime | ASTM D6978-05(2019) | Carmustine: 3.6minutesThioTEPA: 15.9minutes | Carmustine: 76.6minutesThioTEPA: 78.5minutes | Similar: Bothgloves werebelow theminimumpermeationtime of 240minutesspecified in thestandard. |
| CarmustineandThioTEPACaution/WarningStatements | NA | WARNING: Not for usewith: Carmustine,ThioTEPA | Caution: Thefollowingchemotherapy drugshave lowpermeation times:Carmustine(3.3mg/ml): 76.6minutes andThioTEPA (10mg/ml): 78.5minutesrespectively. | Different: Thepredicate has awarning due toextremely lowpermeationtimes while thesubject devicehas a cautionstatementbased onpermeationtimes >70minutes. |
| Dimensions:Overalllength | ASTM D6319Minimum:230mm | 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 complywith widthdimensions | Same |
| Dimensions:Palm & FingerThickness | ASTM D6319Minimum Palm:0.05mmMinimumFinger: 0.05mm | All sizes comply withPalm & Finger Thicknessdimensions | All sizes comply withPalm & FingerThicknessdimensions | 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 | ASTMD6319Minimum: 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 |
| Texturedfingertips | NA | Yes | Yes | Same |
| Biocompatibilitysystemictoxicity | ISO 10993-11:2017(E) -Biological evaluationof medical devices -Part 11: Tests forsystemic toxicity | Pass | Pass | Same |
| Biocompatibilityirritation | 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 | ANSI/AAMI/ISO10993-10:2021(E)-Biologicalevaluation ofmedical devices —Part 10: Tests forskin sensitization | Pass | Pass | Same |
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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)
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- . 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)
- . 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)
| Brief descriptionof non-clinicaltests: | Test | Standard | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimensions | ASTM D 6319 | Meetsrequirements | ||
| Length | 230 mm minimum | |||
| Width (mean) | 70 mm minimum | |||
| Finger thicknessPalm thickness | 0.05 mm minimum0.05 mm minimum | |||
| Physical Properties | ASTM D 6319 | AQL 4.0BeforeTensile Strength: ≥14MPaUltimate elongation:≥500%AfterTensile Strength: ≥14MPaUltimate elongation:≥400% | Meetsrequirements | |
| Freedom fromPinholes | ASTM D 6319ASTM D 5151 | AQL 2.5No leakage | Meetsrequirements | |
| Power - Free | ASTM D 6124ASTM D 6319 | ≤ 2 mg / glove | Meetsrequirements |
Table 5.4. Description of Non-Clinical Tests
{14}------------------------------------------------
KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves
Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate,
Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid Traditional 510(k)
| ISOIrritationStudy | ISO 10993, Part 23 | Primary IrritationIndex | Under theconditions ofthe | |
|---|---|---|---|---|
| $\leq$ 0.4 | study the device isnot an irritant |
| ISO SystemicToxicityStudy | ISO 10993, Part 11 | No animals treatedwith testextractsexhibit greaterreaction than controlanimals | No evidence ofAcute systemictoxicity |
|---|---|---|---|
| ISO DermalSensitization | ISO 10993, Part 10 | Grade < 1 | 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 240minutesfor each of the 24chemotherapydrugs and opioiddrug listedabove. Refer toTable 5.2 forminimumbreakthroughdetection times. |
10. Conclusion:
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K200072, KIMTECH™ Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid
§ 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.