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
Device Facts
| Record ID | 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 |
| Applicant | Kimberly-Clark Corporation |
| Product Code | LZA · General Hospital |
| Decision Date | Jul 21, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
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.
Device Story
Single-use, non-sterile, nitrile powder-free examination gloves; 245mm length; dark magenta color. Worn by healthcare examiners to prevent cross-contamination. Tested for permeation resistance against 24 chemotherapy drugs, fentanyl citrate, and simulated gastric acid per ASTM D6978-05. Provides barrier protection; alerts users to specific low-permeation drugs (Carmustine, ThioTEPA) via caution labeling. Used in clinical settings; protects examiner from patient contaminants and hazardous drug exposure.
Clinical Evidence
Bench testing only. No clinical data. Performance verified via ASTM standards for dimensions (D6319), physical properties (D412, D573), pinhole detection (D5151), residual powder (D6124), and chemotherapy/fentanyl permeation (D6978-05). Biocompatibility testing (ISO 10993-10, 11, 23) confirmed no sensitization, irritation, or systemic toxicity.
Technological Characteristics
Material: Synthetic copolymers of acrylonitrile and butadiene (nitrile). Form: Single-layer, powder-free, textured fingertips, 245mm length. Standards: ASTM D6319, ASTM D6978-05, ISO 10993. Connectivity: None. Sterilization: Non-sterile.
Indications for Use
Indicated for use as a non-sterile, disposable patient examination glove worn on the examiner's hand to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs, opioid fentanyl citrate, simulated gastric acid, and fentanyl in simulated gastric acid.
Regulatory Classification
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.
Predicate Devices
- KIMTECH™ Purple Nitrile Powder-free Exam Glove (K200072)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
{1}------------------------------------------------
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
{2}------------------------------------------------
# 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 Breakthrough<br>Detection 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.
{3}------------------------------------------------
# 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 Breakthrough<br>Detection 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/Fentanyl<br>Citrate 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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to the requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS 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) 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 Road<br>Roswell, Georgia 30076 |
| Phone: | +1 770 587 8000 |
| Contact person: | Kimberly Tempas<br>Associate Director, Regulatory Affairs |
|-----------------|-----------------------------------------------------------|
| | 2100 Winchester Road<br>Neenah, WI 54956 |
| Phone: | +1 (920) 721-4084 |
| Email: | Kimberly. Tempas@kcc.com |
## 3. Device Information
| Trade Name: | KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves<br>Tested for Use with Chemotherapy Drugs, Opioid Fentanyl<br>Citrate, Simulated Gastric Acid and Fentanyl in Simulated<br>Gastric Acid |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Nitrile powder-free patient exam glove for use with<br>chemotherapy drugs and fentanyl |
| Classification Name: | Patient Examination Glove |
| Regulation: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
{5}------------------------------------------------
| 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.
{6}------------------------------------------------
| Chemotherapy Drug | Concentration | Minimum Breakthrough<br>Detection 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 Breakthrough<br>Detection 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<br>Fluid/Fentanyl Citrate Injection<br>Mix | 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.
7. Predicate & Subject Technological Characteristics Comparison Table
Table 5.3. Comparison between Subject and Predicate Devices
{7}------------------------------------------------
| Attributes | Standard Where<br>Limits Test Limits<br>Set | Purple<br>K200072<br>(Predicate) | Polaris<br>(Subject Device) | Comparison |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Regulation | NA | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Product<br>Codes | NA | LZA, LZC, QDO | LZA, LZC, QDO, OPJ | Same |
| Common<br>Name | NA | Examination glove | Examination<br>glove | Same |
| Sizes | NA | Five sizes:<br>XS, S, M, L, XL | Five sizes:<br>XS, S, M, L, XL | Same |
| Base<br>Material | NA | Nitrile | Nitrile | Same |
| Color | NA | Purple | Dark Magenta | Similar:<br>Biocompatibility<br>& physical<br>attributes testing<br>show that the<br>difference in<br>color does not<br>alter glove<br>safety or<br>performance. |
| Glove<br>formulation | NA | KC Purple Nitrile<br>9.5 Chemo<br>Formulation | Proprietary<br>formula | Similar:<br>Formulations<br>share similar<br>materials and<br>physical<br>characteristics;<br>biocompatibility<br>and physical<br>properties<br>testing show that<br>the subject<br>device's<br>formulation does<br>not reduce glove<br>safety or<br>performance. |
| Glove layers | NA | Single layer | Single layer | Same |
| Sterile or<br>Non- Sterile | NA | Non-Sterile | Non-Sterile | Same |
| Prescription<br>or OTC | NA | OTC | OTC | Same |
| Single Use<br>Disposable | NA | Yes | Yes | Same |
| Intended<br>Use/indicatio<br>ns for use | NA | The device is a<br>disposable device<br>intended for<br>medical purposes<br>that is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patients<br>and examiner.<br>KIMTECHTM Purple<br>NitrileTM Powder free<br>Examination Gloves<br>are Tested for Use<br>with Chemotherapy<br>Drugs, Opioid<br>Fentanyl Citrate,<br>Simulated Gastric<br>Acid, and Fentanyl in<br>Simulated Gastric<br>Acid. | The nitrile<br>powder free<br>patient<br>examination<br>glove is a non-<br>sterile disposable<br>device intended<br>for medical<br>purposes that is<br>worn on the<br>examiner's hand<br>to prevent<br>contamination<br>between patient<br>and examiner.<br>In addition to<br>routine<br>examination<br>glove's intended<br>use, the gloves<br>are Tested for<br>Use with<br>Chemotherapy<br>Drugs, Opioid<br>Fentanyl Citrate,<br>Simulated<br>Gastric Acid and<br>Fentanyl in<br>Simulated<br>Gastric Acid. | Similar:<br>The subject<br>device removed<br>"or finger"<br>because it is<br>intended to be<br>worn on the<br>hand, not the<br>finger. |
| Attributes | Standard Where<br>Limits Test Limits<br>Set | Purple<br>K200072<br>(Predicate) | Polaris<br>(Subject Device) | Comparison |
| Indications<br>for Use<br>claims: | Chemotherapy<br>drugs tested for<br>permeation and<br>degradation in<br>accordance with<br>ASTM D6978-05<br>(2019) | Chemotherapy<br>Drugs Tested:<br>1. Carmustine<br>2. Cyclophosphami<br>de<br>3. Doxorubicin HCL<br>4. Etoposide<br>5. Fluorouracil<br>6. Mitoxantrone<br>7. Paclitaxel<br>8. ThioTEPA<br>9. Dacarbazine<br>10. Ifosfamide<br>11. Vincristine<br>Sulfate<br>12. Bleomycin Sulfate<br>13. Busulfan<br>14. Cytarabine<br>15. Dacarbazine<br>16. Daunorubicin<br>17. Docetaxel<br>18. Epirubicin<br>19. Fludarabine<br>20. Gemcitabine<br>21. Idarubicin<br>22. Mechlorethamine<br>HCL<br>23. Melphalan<br>24. Methotrexate<br>25. Mitomycin C<br>26. Osplaten<br>27. Paraplatin<br>28. Rituximab | Chemotherapy<br>Drugs Tested:<br>1. Avastin<br>2. Cabazitaxel<br>3. Capecitabine<br>4. Carmustine<br>5. Cisplatin<br>6. Cyclophospha<br>mide<br>7. Dacarbazine<br>8. Doxorubicin<br>HCL<br>9. Eribulin<br>Mesylate<br>10. Etoposide<br>11. Floxuridine<br>12. Fluorouracil<br>13. Ifosfamide<br>14. Lenvatinib<br>15. Mitoxantrone<br>16. Oxaliplatin<br>17. Paclitaxel<br>18. Pemetrexed<br>19. Sorafenib<br>Tosylate<br>20. Tamoxifen<br>21. ThioTEPA<br>22. Vinblastine<br>Sulfate<br>23. Vincristine<br>Sulfate<br>24. Vinorelbine | Similar: Both<br>have been<br>tested with a<br>common list of<br>chemotherapy<br>drugs in<br>accordance<br>with the same<br>test method,<br>but the subject<br>glove has been<br>tested for some<br>different<br>chemotherapy<br>drugs to better<br>meet current<br>user and<br>chemotherapy<br>treatment<br>needs. |
| Attributes | Standard Where<br>Limits Test<br>Limits Set | Purple<br>K200072(Predicate) | Polaris<br>(Subject Device) | Comparison |
| Permeation<br>and<br>degradation<br>tests of<br>other<br>substances | ASTM D6978-05<br>(2019) | Passed permeation<br>testing for:<br>Fentanyl citrate<br>Simulated gastric acid<br>50/50 mix of fentanyl<br>and gastric acid | Passed permeation<br>testing for:<br>Fentanyl citrate<br>Simulated gastric<br>acid<br>50/50 mix of<br>fentanyl and gastric<br>acid | Same |
| Carmustine<br>and<br>ThioTEPA<br>Permeation<br>time | ASTM D6978-05<br>(2019) | Carmustine: 3.6<br>minutes<br>ThioTEPA: 15.9<br>minutes | Carmustine: 76.6<br>minutes<br>ThioTEPA: 78.5<br>minutes | Similar: Both<br>gloves were<br>below the<br>minimum<br>permeation<br>time of 240<br>minutes<br>specified in the<br>standard. |
| Carmustine<br>and<br>ThioTEPA<br>Caution/<br>Warning<br>Statements | NA | WARNING: Not for use<br>with: Carmustine,<br>ThioTEPA | Caution: The<br>following<br>chemotherapy drugs<br>have low<br>permeation times:<br>Carmustine<br>(3.3mg/ml): 76.6<br>minutes and<br>ThioTEPA (10<br>mg/ml): 78.5<br>minutes<br>respectively. | Different: The<br>predicate has a<br>warning due to<br>extremely low<br>permeation<br>times while the<br>subject device<br>has a caution<br>statement<br>based on<br>permeation<br>times >70<br>minutes. |
| Dimensions:<br>Overall<br>length | ASTM D6319<br>Minimum:<br>230mm | All sizes comply with<br>length dimensions | All sizes comply with<br>length dimensions | Same |
| Dimensions:<br>Width (mean) | ASTM D6319<br>Minimum: 70<br>+10mm | All sizes comply with<br>width dimensions | All sizes comply<br>with width<br>dimensions | Same |
| Dimensions:<br>Palm & Finger<br>Thickness | ASTM D6319<br>Minimum Palm:<br>0.05mm<br>Minimum<br>Finger: 0.05mm | All sizes comply with<br>Palm & Finger Thickness<br>dimensions | All sizes comply with<br>Palm & Finger<br>Thickness<br>dimensions | Same |
| Attributes | Standard Where<br>Limits Test Limits<br>Set | Purple<br>K200072(Predicate) | Polaris<br>(Subject Device) | Comparison |
| Tensile<br>strength:<br>Before & After<br>Aging | ASTM D6319<br>Min Before: 14MPa<br>After: 14Mpa | Complies both<br>before and after<br>accelerated aging. | Complies both<br>before and after<br>accelerated aging. | Same |
| Ultimate<br>elongation<br>Before & After<br>aging | ASTM<br>D6319<br>Minimum: Before:<br>500%<br>After:400% | Complies both before<br>and after accelerated<br>aging. | Complies both<br>before and after<br>accelerated aging. | Same |
| Freedom from<br>pinholes | ASTM D6319 G1,<br>AQL 2.5<br>7 Accept<br>8 Reject | Pass<br>(AQL 1.5) | Pass<br>(AQL 0.65) | Same: Both<br>gloves pass<br>the tests.<br>The subject<br>glove AQL is<br>tighter and<br>allows fewer<br>pinhole<br>defects. |
| Powder-Free | ASTM D6319-19<br>(2019) Maximum<br><2mg/glove | Passed at <2mg /<br>glove in accordance<br>with the standard | Passed at <2mg /<br>glove in<br>accordance with<br>the standard | Same |
| Textured<br>fingertips | NA | Yes | Yes | Same |
| Biocompatibility<br>systemic<br>toxicity | ISO 10993-<br>11:2017(E) -<br>Biological evaluation<br>of medical devices -<br>Part 11: Tests for<br>systemic toxicity | Pass | Pass | Same |
| Biocompatibility<br>irritation | ANSI/AAMI/ISO<br>10993-23:2021(E) -<br>Biological<br>evaluation of<br>medical devices -<br>Part 23: Tests for<br>irritation | Pass | Pass | Same |
| Attributes | Standard Where<br>Limits Test Limits<br>Set | Purple<br>K200072(Predicate) | Polaris<br>(Subject Device) | Comparison |
| Biocompatibility<br>skin<br>sensitization | ANSI/AAMI/ISO<br>10993-10:2021(E)-<br>Biological<br>evaluation of<br>medical devices —<br>Part 10: Tests for<br>skin sensitization | Pass | Pass | Same |
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
# 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)
{13}------------------------------------------------
- . 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 description<br>of non-clinical<br>tests: | Test | Standard | Acceptance Criteria | Results |
|------------------------------------------------|--------------------------|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| | Dimensions | ASTM D 6319 | | Meets<br>requirements |
| | | Length | 230 mm minimum | |
| | | Width (mean) | 70 mm minimum | |
| | | Finger thickness<br>Palm thickness | 0.05 mm minimum<br>0.05 mm minimum | |
| | Physical Properties | ASTM D 6319 | AQL 4.0<br><br>Before<br>Tensile Strength: ≥14<br>MPa<br>Ultimate elongation:<br>≥500%<br><br>After<br>Tensile Strength: ≥14<br>MPa<br>Ultimate elongation:<br>≥400% | Meets<br>requirements |
| | Freedom from<br>Pinholes | ASTM D 6319<br>ASTM D 5151 | AQL 2.5<br>No leakage | Meets<br>requirements |
| | Power - Free | ASTM D 6124<br>ASTM D 6319 | ≤ 2 mg / glove | Meets<br>requirements |
# 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)
| | ISO<br>Irritation<br>Study | ISO 10993, Part 23 | Primary Irritation<br>Index | Under the<br>conditions of<br>the |
|--|----------------------------|--------------------|-----------------------------|----------------------------------------|
| | | | $\leq$ 0.4 | study the device is<br>not an irritant |
| ISO Systemic<br>Toxicity<br>Study | ISO 10993, Part 11 | No animals treated<br>with test<br>extracts<br>exhibit greater<br>reaction than control<br>animals | No evidence of<br>Acute systemic<br>toxicity…
