KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid

K200072 · Kimberly-Clark Corporation · LZA · Apr 10, 2020 · General Hospital

Device Facts

• Record ID: K200072
• Device Name: KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid
• Applicant: Kimberly-Clark Corporation
• Product Code: LZA · General Hospital
• Decision Date: Apr 10, 2020
• 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 non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

KIMTECH Purple Nitrile Powder Free Examination Gloves are single-use, non-sterile, disposable nitrile gloves. Designed for medical examination to prevent cross-contamination between patient and examiner. Subject device is identical to predicate K170686, with additional testing for Fentanyl Citrate, simulated gastric acid, and Fentanyl in simulated gastric acid to support QDO product code claims. Gloves are worn by clinicians in healthcare settings. Performance is verified via permeation testing against chemotherapy drugs and opioids per ASTM D6978-05. Warning provided for specific drugs (Carmustine, Thiotepa) due to low permeation times. Benefits include barrier protection against patient contaminants and specific chemical agents.

Clinical Evidence

Bench testing only. No clinical data. Performance verified against ASTM standards including D6319 (physical dimensions, tensile strength, elongation), D5151 (freedom from holes), D6124 (residual powder), and D6978-05 (chemotherapy drug/fentanyl permeation). Biocompatibility testing performed per ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (systemic toxicity).

Technological Characteristics

Material: Synthetic copolymer of acrylonitrile and butadiene (nitrile). Form factor: Powder-free, purple, non-sterile, disposable examination glove. Sizes: XS, M, L, XL. Standards: ASTM D6319, D412, D573, D3767, D5151, D6124, D6978. Biocompatibility: ISO 10993-10, ISO 10993-11. No software or electronic components.

Indications for Use

Indicated for use as a non-sterile, disposable patient examination glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs, the 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

• Brightway Non-Powdered Nitrile Examination Glove (K170686)
• Non-Sterile Powder-Free Nitrile Examination Glove Black (K182241)

Submission Summary (Full Text)

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April 10, 2020

Kimberly-Clark Corporation % Wava Truscott Consultant Truscott MedSci Associates, LLC 180 Burkemeade Ct Roswell, Georgia 30075

Re: K200072

Trade/Device Name: KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the 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, QDO Dated: January 15, 2020 Received: January 16, 2020

Dear Wava Truscott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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.

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

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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 mediation-emitting products, including information about labeling regulations, please see Device (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

David Krause

for CAPT Elizabeth Claverie, M.S. 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) K200072

#### Device Name

KIMTECH™ Purple Nitrile™ Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentany1 Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid

#### Indications for Use (Describe)

The Nittile Powder Free patient examination glove is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Test Results Follow:

| Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time |
|--------------------------|--------------------------|-------------------------------------|
| Blenoxane | (15mg/mL),(15,000 ppm) | >240 |
| Busulfan | (6mg/mL),(6,000 ppm) | >240 |
| Carmustine (BiCNU) | (3.3mg/mL),(3,300 ppm) | >3.6 |
| Cisplatin | (1mg/mL),(1,000 ppm) | >240 |
| Cyclophosphamide/cytoxan | (20mg/mL),(20,000 ppm) | >240 |
| Cytarabine | (100mg/mL),(100,000 ppm) | >240 |
| Dacarbazine(DTIC) | (10mg/mL),(10,000 ppm) | >240 |
| Daunorubicin | (5mg/mL),(5,000 ppm) | >240 |
| Docetaxel | (10mg/mL),(10,000ppm) | >240 |
| Doxorubicin | (2mg/mL),(2,000 ppm) | >240 |
| Ellence | (2mg/mL),(2,000 ppm) | >240 |
| Etoposide/Toposar | (20mg/mL,(20,000 ppm) | >240 |
| Fludarabine | (25mg/mL),(25,000 ppm) | >240 |
| Fluorouracil | (50mg/mL),(50,000 ppm) | >240 |
| Gemcitabine | (38mg/mL),(38,000 ppm) | >240 |
| Idarubicin | (1mg/mL),(1,000 ppm) | >240 |
| Ifosfamide | (50mg/mL),(50,000 ppm) | >240 |
| Irinotecan | (20mg/mL),(20,000 ppm) | >240 |
| Mechlorethamine HCL | (1 mg/mL),(1,000 ppm) | >240 |
| Melphalan | (5mg/mL),(5,000 ppm) | >240 |
| Methotrexate | (25mg/mL),(25,000 ppm) | >240 |
| Mitomycin C | (0.5mg/mL),(500 ppm) | >240 |
| Mitoxantrone | (2mg/mL),(2,000 ppm) | >240 |
| Paclitaxel | (6mg/mL),(6,000 ppm) | >240 |
| Paraplatin | (10mg/mL),(10,000 ppm) | >240 |
| Rituximab | (10mg/mL),(10,000 ppm) | >240 |
| Thiotepa | (10mg/mL),(10,000 ppm) | >15.9 |
| Trisenox | (0.1 mg/mL),(100 ppm) | >240 |
| Vincristine Sulfate | (1 mg/ m ),(1,000 ppm) | >240 |
| Fentanyl Citrate | 100mcg/2mL | >240 |
| Gastric Acid (simulated) | 0.2% NaCl in 0.7% HCL | >240 |
| Fentanyl in Gastric Acid | 50/50 Mix | >240 |

Note: Carmustine and Thiotepa have extremely low permeation times of 3.6 and 15.9 minutes respectively Warning: Do Not Use With: Carmustine, Thiotepa

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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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The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92(c).

510(k) Number: K200072

Preparation Date: April 6, 2020 510(k) Summary

KIMTECH™ Purple Nitrile™ Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid

## 1. Submitter:

| Company Name:<br>Address:<br>Country:<br>Phone: | Kimberly-Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076<br>United States of America<br>[phone] |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Juan M. Marquez<br>Director, Regulatory Affairs<br>Kimberly-Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076 |
| Phone | [phone] |
| Fax | [phone] |
| E-mail: | [e-mail] |

#### 2. Correspondent:

| Correspondent: | Wava Truscott, PhD. |
|----------------|-----------------------------------------|
| Company Name: | Truscott MedSci Associates, LLC |
| Address: | 180 Burkemeade Ct.<br>Roswell, GA 30075 |
| Phone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |

#### 3. Device information:

| Device Trade Name: | KIMTECH™ Purple Nitrile™ Powder free Examination Gloves Tested for<br>Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric<br>Acid, and Fentanyl in Simulated Gastric Acid |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Patient Examination Glove |
| Classification: | Class I (general controls) |
| Regulation Number: | 21 CFR 880-6250 |
| Common name: | Powder-free Nitrile Exam Glove for use with Chemotherapy drugs and<br>Fentanyl |
| Product Code: | LZC, LZA, QDO |

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## 4. Predicate Device:

K170686: Brightway Non-Powdered Nitrile Examination Glove Tested for use with Chemotherapy gloves: LZA, LZC (Subject Glove is exactly the same glove, but seeking the additional QDO claim)

K182241: Non-Sterile Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy gloves: LZA, LZC, QDO

## 5. Description of the Device:

KIMTECH™ Purple Nitrile™ Examination Gloves, Powder Free, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric acid and Fentanyl in Simulated Gastric acid are single use only, non-sterile, disposable gloves. The powder-free gloves are made of a synthetic copolymer of acrylonitrile and butadiene with a purple color additive. The gloves are available in extra small, medium, large, and extra-large sizes.

## 6. Indications for Use:

The Nitrile Powder Free patient examination glove is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

| Test Results Follow:<br>Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time |
|-----------------------------------------------------|--------------------------|-------------------------------------|
| Blenoxane | (15mg/mL),(15,000 ppm) | >240 |
| Busulfan | (6mg/mL),(6,000 ppm) | >240 |
| Carmustine(BiCNU) | (3.3mg/mL),(3,300 ppm) | >3.6 |
| Cisplatin | (1mg/mL),(1,000 ppm) | >240 |
| Cyclophosphamide/cytoxan | (20mg/mL),(20,000 ppm) | >240 |
| Cytarabine | (100mg/mL),(100,000 ppm) | >240 |
| Dacarbazine(DTIC) | (10mg/mL),(10,000 ppm) | >240 |
| Daunorubicin | (5mg/mL),(5,000 ppm) | >240 |
| Docetaxel | (10mg/mL),(10,000ppm) | >240 |
| Doxorubicin | (2mg/mL),(2,000 ppm) | >240 |
| Ellence | (2mg/mL),(2,000 ppm) | >240 |
| Etoposide/Toposar | (20mg/mL),(20,000 ppm) | >240 |
| Fludarabine | (25mg/mL),(25,000 ppm) | >240 |
| Fluorouracil | (50mg/mL),(50,000 ppm) | >240 |
| Gemcitabine | (38mg/mL),(38,000 ppm) | >240 |
| Idarubicin | (1mg/mL),(1,000 ppm) | >240 |
| Ifosfamide | (50mg/mL),(50,000 ppm) | >240 |
| Irinotecan | (20mg/mL),(20,000 ppm) | >240 |
| Mechlorethamine HCL | (1 mg/mL),(1,000 ppm) | >240 |
| Melphalan | (5mg/mL),(5,000 ppm) | >240 |
| Methotrexate | (25mg/mL),(25,000 ppm) | >240 |
| Mitomycin C | (0.5mg/mL),(500 ppm) | >240 |
| Mitoxantrone | (2mg/mL),(2,000 ppm) | >240 |
| Paclitaxel | (6mg/mL),(6,000 ppm) | >240 |
| Paraplatin | (10mg/mL),(10,000 ppm) | >240 |
| Rituximab | (10mg/mL),(10,000 ppm) | >240 |
| Thiotepa | (10mg/mL),(10,000 ppm) | >15.9 |
| Trisenox | (0.1 mg/mL),(100 ppm) | >240 |
| Vincristine Sulfate | (1 mg/m),(1,000 ppm) | >240 |
| Fentanyl Opioid and Gastric acid tested as follows: | | |
| Fentanyl Citrate | 100mcg/2mL | >240 |
| Gastric Acid (simulated) | 0.2% NaCl in 0.7% HCL | >240 |

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Fentanyl in Gastric Acid 50/50 Mix >240 Note: Carmustine and Thiotepa have extremely low permeation times of 3.6 and 15.9 minutes respectively Warning: Do Not Use With: Carmustine, Thiotepa

| Attributes | Standard<br>Where Test<br>Sets Limits | a) Predicate<br>Device:<br>K182241 | b) Predicate<br>Device: K170686 | Subject Device Glove | How Does Subject<br>Glove Compare to<br>Predicates |
|---------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name<br>of Device Type | NA | Examination<br>Glove | Examination<br>Glove | Examination<br>Glove | a) Same<br>b) Same |
| Base Material | NA | Nitrile | Nitrile | Nitrile | c) Same<br>d) Same |
| Color | NA | Black | Purple | Purple | a) Different than<br>K182241; but,<br>biocompatibility, &<br>physical attributes,<br>show difference in<br>color has not<br>altered glove safety<br>or performance<br>b) Identical to<br>K170686 |
| Glove<br>formulation | NA | Owners own<br>proprietary<br>formula | KC Purple Nitrile<br>9.5 Chemo<br>Formulation | KC Purple Nitrile<br>9.5 Chemo<br>Formulation | a) Different than<br>K182241, actual<br>formula unknown<br>b) Identical to<br>K170686 |
| Product Codes | NA | LZA, LZC, QDO | LZA, LZC | LZA, LZC, QDO | a) Same<br>b) Similar-no QDO |
| Sterile vs Non-<br>Sterile | NA | Non-Sterile | Non-Sterile | Non-Sterile | a) Same<br>b) Same |
| Prescription or<br>OTC | NA | OTC | OTC | OTC | a) Same<br>b) Same |
| Attributes | Standard<br>Where<br>Limits<br>Test<br>Limits Set | a) Predicate<br>Device: K182241 | b) Predicate<br>Device: K170686 | Subject Device<br>Glove | How Does<br>Subject Glove<br>Compare to<br>Predicates |
| Single Use-<br>Disposable | NA | Yes | Yes | Yes | a) Same<br>b) Same |
| Intended 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 patient<br>and examiner. | 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 patient<br>and examiner. | 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 patient<br>and examiner. | a) Same<br>b) Same |
| Indications for<br>use (summary) | NA | In addition to<br>routine<br>examination<br>glove's intended<br>use, the Subject<br>Glove was Tested<br>for use with<br>chemotherapy<br>drugs and the<br>opioid Fentanyl<br>SEE Below for<br>specifics | In addition to<br>routine<br>examination<br>glove's intended<br>use, the Subject<br>Glove was Tested<br>for use with<br>Chemotherapy<br>drugs<br>SEE Below for<br>specifics | KIMTECHTM<br>Purple NitrileTM<br>Powder Free<br>Examination<br>Gloves Tested for<br>Use with<br>Chemotherapy<br>Drugs, the<br>Fentanyl Citrate,<br>Gastric acid, and<br>Fentanyl in<br>Gastric acid<br>SEE Below for<br>specifics | a) Similar: Both<br>tested with<br>Chemotherapy drugs<br>but some drugs<br>different. Both also<br>tested for Fentanyl,<br>but Subject glove<br>also tested with<br>gastric acid and<br>Fentanyl in gastric<br>acid<br>b) similar: Because<br>they are same glove,<br>same Chemo drugs<br>test breakthrough<br>times identical to<br>K170686; because<br>same test data, but<br>subject glove also<br>tested for Fentanyl<br>citrate, gastric acid,<br>and Fentanyl in<br>gastric acid to be<br>cleared for QDO<br>claims |
| Attributes | Standard<br>Tests<br>Where<br>Limits Set | a) Predicate<br>Device: K182241<br>Chemotherapy<br>drugs tested: | b) Predicate<br>Device: K170686<br>Chemotherapy<br>drugs tested: | Subject Device Glove<br>Chemotherapy<br>drugs tested: | How Does<br>Subject Glove<br>Compare to<br>Predicates |
| Indications<br>for Use<br>Claims | ASTM<br>D6978 -05<br>Re -<br>approved<br>2013 | • Carmustine<br>(BCN U)<br>• Cisplatin,<br>• Cyclophosphamide<br>(Cytoxan),<br>• Dacarbazine<br>(DTIC)<br>• Doxorubicin<br>Hydrochloride,<br>• Etoposide<br>(Toposar)<br>• Fluorouracil,<br>• Methotrexate<br>• Paclitazel (Taxol),<br>• Thiotepa<br>• Vincristine Sulfate<br><br>Note Carmustine<br>(BCN U) and<br>Thiotepa have<br>low permeation<br>times<br><br>In Addition:<br>• Fentanyl | • Blenoxane<br>• Busulfan<br>• Carmustine<br>• Cisplatin<br>• Cyclophosphamide<br>/Cytoxan<br>• Cytarabine<br>• Dacarbazine<br>• Daunorubicin<br>• Docetaxel<br>• Doxorubicin<br>• Ellence<br>• Etoposide/<br>Toposar<br>• Fluorouracil<br>• Gemcitabine<br>• Idarubicin<br>• Ifosfamide<br>• Mechlorethamine HCL<br>• Melphalan<br>• Methotrexate<br>• Mitomycin C<br>• Mitoxantrone<br>• Paclitaxel<br>• Paraplatin<br>• Rituxmab<br>• Thiotepa<br>• Trisenox<br>• Vincristine Sulfate<br>All >240min except<br>ThioTEPA;<br>Ca1mustine | • Blenoxane<br>• Busulfan<br>• Carmustine<br>• Cisplatin<br>• Cyclophosphamide<br>/Cytoxan<br>• Cytarabine<br>• Dacarbazine<br>• Daunorubicin<br>• Docetaxel<br>• Doxorubicin<br>• Ellence<br>• Etoposide/<br>Toposar<br>• Fluorouracil<br>• Gemcitabine<br>• Idarubicin<br>• Ifosfamide<br>• Mechlorethamine HCL<br>• Melphalan<br>• Methotrexate<br>• Mitomycin C<br>• Mitoxantrone<br>• Paclitaxel<br>• Paraplatin<br>• Rituximab<br>• Thiotepa<br>• Trisenox<br>• Vincristine Sulfate<br>All >240min except<br>ThioTEPA; Carmustine<br>• Fentanyl Citrate<br>• Gastric acid<br>• Fentanyl Citrate in<br>Gastric acid | a) Similar: both<br>tested CHEMO<br>Drugs for<br>pem1eation, but<br>Subject glove<br>tested more. Both<br>tested Fentanyl, but<br>Subject glove also<br>tested Gastricacid<br>b) Similar: The<br>subject glove has<br>listed the same<br>29<br>Chemotherapy<br>drugs as (b) because<br>same glove and<br>the data from<br>K170686 used for<br>Subject glove data<br>submission, but the<br>glove has now also<br>be e n tested with<br>additional Fentanyl<br>and Gastric Acid to<br>acquire the QDO<br>code. |
| Attributes | Standard<br>Where Limits<br>Test<br>Limits Set | a) Predicate Device:<br>K182241 | b) Predicate Device:<br>K170686 | Subject Device Glove | How Does Subject<br>Glove Compare to<br>Predicates |
| Caution/<br>Warning<br>Statements | NA | Note Carmustine<br>(BCNU) and<br>Thiotepa have<br>low permeation<br>times | Note: Carmustine<br>and Thiotepa<br>have extremely<br>low permeation<br>times of 3.6 and<br>15.9 minutes<br>respectively.<br>WARNING:<br>Not for use<br>with:<br>Carmustine,<br>Thiotepa | Note: Carmustine<br>and Thiotepa<br>have extremely<br>low permeation<br>times of 3.6 and<br>15.9 minutes<br>respectively.<br>WARNING:<br>Not for Use With:<br>Carmustine,<br>Thiotepa | a) Similar:<br>Predicate<br>K182241 does<br>not list the<br>breakthrough<br>times in the<br>"Note," nor does<br>it instruct wearer<br>not to use with<br>Carmustine,<br>Thiotepa. Subject<br>Glove is more<br>informative<br>b) Same |
| Dimensions:<br>Overall length | ASTM D6319<br>Minimum:<br>230mm | All sizes comply with<br>length dimensions | 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>+<br>10mm | All sizes comply with<br>length dimensions | All sizes comply with<br>length dimensions | All sizes comply with<br>length dimensions | Same |
| Dimensions:<br>Palm & Finger<br>Thickness | ASTM D6319<br>Min.Palm:<br>0.05mm<br>Finger:<br>0.05mm | All sizes comply with<br>length dimensions | All sizes comply with<br>length dimensions | All sizes comply with<br>length dimensions | Same |
| Tensile<br>strength:<br>Before &<br>After Aging | ASTM D6319<br>Min Before:<br>14MPa<br>After: 14Mpa | Complies both<br>before and after<br>accelerated aging | Complies both<br>before and after<br>accelerated aging | Complies both<br>before and after<br>accelerated aging | Same |
| Attributes | Standard Where<br>Limits Test<br>Limits Set | a) Predicate Dev<br>ice: K182241 | b) Predicate Device:<br>K170686 | Subject Device Glove | How Does<br>Subject Glove<br>Compare to<br>Predicates |
| Ultimate<br>elongation<br>Before & After<br>aging | ASTM<br>D6319<br>Minimum:<br>Before: 500%<br>After:<br>400% | Complies both<br>before and after<br>accelerated aging | Complies both<br>before and after<br>accelerated aging | Complies both before<br>and after accelerated<br>aging | Same |
| Freedom from<br>holes: | ASTM<br>D6319 G1,<br>AQL 2.5<br>7 Accept<br>8 Reject | Pass | Pass | Pass | Same |
| Powder-Free | ASTM<br>D6319<br>Maximum<br><2mg/<br>glove | Less than 2.0mg<br>per glove;<br>Pass | Less than 2.0mg<br>per glove;<br>Pass | Less than 2.0mg<br>per glove;<br>Pass | Same |
| Biocompatibility | ISO<br>10993- 11<br>Systemic<br>Toxicity<br>Test | Under conditions<br>of the study, the<br>device extracts did<br>not elicit a<br>systemic<br>response in the<br>model animal. | Under conditions<br>of the study, the<br>device extracts did<br>not elicit a<br>systemic<br>response in the<br>model animal. | Under conditions<br>of the study, the<br>device extracts did<br>not elicit a<br>systemic<br>response in the<br>model animal. | Same |
| | ISO<br>10993-10<br>Primary<br>Skin<br>Irritation<br>on Rabbits | Under Condit ions<br>of this study, the<br>polar and non-<br>polar device<br>extracts were<br>found not to be an<br>irritant to the<br>animal model. | Under Condit ions<br>of this study, the<br>polar and non-<br>polar device<br>extracts were<br>found not to be an<br>irritant to the<br>animal model. | Under Condit ions<br>of this study, the<br>polar and non-<br>polar device<br>extracts were<br>found not to be an<br>irritant to the<br>animal model. | Same |
| | ISO<br>10993-10<br>Magnusson<br>& Kligman<br>Guinea pig<br>Maximization | Under Condit<br>ions of this<br>study, the polar<br>and non- polar<br>device extracts<br>were found not<br>to be<br>sensitizers to<br>the animal<br>model. | Under Conditions<br>of this study, the<br>polar and non-<br>polar device<br>extracts were<br>found not to be<br>sensitizers to the<br>animal model. | Under Conditions of<br>this study, the polar<br>and non- polar<br>device extracts<br>were found not to<br>be sensitizers to the<br>animal model. | Same |

# 7. Predicate & Subject Technological Characteristics Comparison Table

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# 8. Summary of Non-Clinical Performance Tests:

Non-Clinical Testing was conducted to demonstrate that the proposed device met all required design specifications. The test results demonstrated that the proposed device met the performance criteria as specified utilizing the following test methods, standards, and specificati…