PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves

K220547 · O&M Halyard, Inc. · LZA · Jun 2, 2022 · General Hospital

Device Facts

• Record ID: K220547
• Device Name: PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
• Applicant: O&M Halyard, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Jun 2, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable nitrile patient examination gloves; dark blue; chlorinated; powder-free; textured fingertips; ambidextrous. Available in two lengths (9.5 inches and 12 inches). Used by healthcare professionals in clinical settings to provide a barrier against contamination between patient and examiner. Tested for permeation resistance against various chemotherapy drugs, fentanyl citrate, and simulated gastric acid per ASTM D6978-05. Provides protection for clinicians handling hazardous drugs; however, specific drugs (Carmustine, ThioTEPA) show breakthrough and are contraindicated. Benefits include reduced risk of cross-contamination and chemical exposure for the examiner.

Clinical Evidence

Bench testing only. No clinical data. Performance validated via ASTM D6978-05 for chemotherapy drug permeation, ASTM D5151-06 for pinhole leakage (AQL 2.5%), ASTM D6124-06 for residual powder, and ASTM D6319-10 for physical properties/dimensions. Biocompatibility confirmed via ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (systemic toxicity).

Technological Characteristics

Material: Nitrile. Form: Powder-free, textured fingertip, ambidextrous. Dimensions: 9.5-inch or 12-inch length; palm width 60-130mm; thickness 0.10-0.19mm. Standards: ASTM D6319, D5151, D6124, D6978; ISO 10993-10/11. Sterility: Non-sterile. Shelf life: 5 years.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent contamination between patient and examiner. Suitable for use with specific chemotherapy drugs, fentanyl citrate, and gastric acid as listed on the label. Contraindicated for use with Carmustine and ThioTEPA.

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

• Halyard Purple Nitrile Powder-Free Exam Glove with Chemotherapy Drug and Fentanyl Citrate Claim (K200633)

Submission Summary (Full Text)

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June 2, 2022

O&M Halyard, Inc. Angela Bunn Director, Global Regulatory Affairs 1 Edison Drive Alpharetta, Georgia 30005

Re: K220547

Trade/Device Name: PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO Dated: April 28, 2022 Received: May 3, 2022

Dear Angela Bunn:

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.

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

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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 (OS) 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Bifeng Qian, Ph D Acting 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)

#### K220547

#### Device Name

The PureZero MARIN Nitrite Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves

#### Indications for Use (Describe)

The PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:

Cisplatin (1 mg/ml) Cyclophosphamide (20 mg/ml) Dacarbazine (10 mg/ml) Doxorubicin HCI (2 mg/ml) Etoposide (20 mg/ml) Fluorouracil (50 mg/ml) Ifosfamide (50 mg/ml) Methotrexate (25 mg/ml) Mitomycin C (0.5 mg/ml) Mitoxantrone HCI (2 mg/ml) Paclitaxel (6 mg/ml) Vincrinstine Sulfate (1 mg/ml) Fentanyl Citrate Injection (100 mcg/2 mL) Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

The following chemotherapy drugs and concentration showed breakthrough detected in less than 90 minutes:

ThioTEPA (10 mg/ml), breakthrough detected at 88.6 minutes

Carmustine (3.3 mg/ml), breakthrough detected at 55.2 minutes

Warning: Not for Use With: Carmustine, ThioTEPA

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

## K220547

| Date Summary<br>was Prepared | February 1, 2022 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter | O & M Halyard, Inc.<br>1 Edison Drive<br>Alpharetta, GA 30005 |
| Primary Contact for<br>this 510(k) Submission | Angela L. Bunn, RAC<br>Tel: [phone]<br>Email: [e-mail] |
| Marketed Common Name | Nitrile Powder-Free Exam Gloves |
| Device Submission Trade Name<br>and Description | PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim<br>PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim |
| Device Common Name | Medical Exam Gloves |
| Device Product Code<br>and Classification Name | LZA Class I, 21 CFR §880.6250 Patient Examination Glove<br>LZC Class I, 21 CFR §880.6250 Patient Examination Glove, Specialty<br>QDO Class 1, 21 CFR §880.6250 Fentanyl and Other Opioid Protection Glove |
| Predicate Device | Halyard Purple Nitrile Powder-Free Exam Glove with Chemotherapy Drug and Fentanyl Citrate Claim (K200633) |
| Subject Device Description | The subject device is a dark blue colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, patient examination gloves. The devices follow consensus standards:<br>ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves<br>ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Applications<br>ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves<br>ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs<br>ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for Systemic Toxicity<br>ISO 10993-10: 2010: Biological evaluation of medical devices - Part 10: |
| Tests for Irritation and Skin Sensitization | |
| Indications for Use | The PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy<br>Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero MARIN-XTRA Nitrile<br>Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and<br>Gastric Acid claim is a disposable device intended for medical purposes that is<br>worn on the examiner's hand to prevent contamination between patient and<br>examiner. |
| | The following chemotherapy drugs and concentration had NO breakthrough<br>detected up to 240 minutes: |
| | Cisplatin (1 mg/ml)<br>Cyclophosphamide (20 mg/ml)<br>Dacarbazine (10 mg/ml)<br>Doxorubicin HCI (2 mg/ml)<br>Etoposide (20 mg/ml)<br>Fluorouracil (50 mg/ml)<br>Ifosfamide (50 mg/ml)<br>Methotrexate (25 mg/ml)<br>Mitomycin C (0.5 mg/ml)<br>Mitoxantrone HCI (2 mg/ml)<br>Paclitaxel (6 mg/ml)<br>Vincrinstine Sulfate (1 mg/ml)<br>Fentanyl Citrate Injection (100 mcg/2 mL)<br>Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution |
| | The following chemotherapy drugs and concentration showed breakthrough<br>detected in less than 90 minutes:<br>ThioTEPA (10 mg/ml), breakthrough detected at 88.6 minutes |
| | The following chemotherapy drugs and concentration showed breakthrough<br>detected in less than 60 minutes: |
| | Carmustine (3.3 mg/ml), breakthrough detected at 55.2 minutes |
| | Warning: Do not use with Carmustine or ThioTEPA |

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| Technological Characteristics Comparison Table | | | |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| | Subject Device<br>K220547 | Predicate Device<br>Halyard Purple Nitrile Powder-<br>Free Exam Glove<br>K200633 | Comparison |
| FDA Product Code | LZC, LZA, QDO | LZC, LZA, QDO | Added QDO for the<br>Fentanyl Claim |
| FDA Classification | Class I | Class I | Same |
| Regulation Number | 880.6250 | 880.6250 | Same |
| Common Name | Medical Exam Glove | Medical Exam Glove | Same |
| Device Trade Name | PureZero MARIN Nitrile Powder-<br>Free Exam Gloves with<br>Chemotherapy Drugs, Fentanyl<br>Citrate and Gastric Acid claim<br>PureZero MARIN-XTRA Nitrile<br>Powder-Free Exam Gloves with<br>Chemotherapy Drugs, Fentanyl<br>Citrate and Gastric Acid claim | Halyard Purple Nitrile Powder-<br>Free Exam Gloves with<br>Chemotherapy Drugs and<br>Fentanyl Citrate claim | Similar |
| Intended Use | The device is a disposable device<br>intended for medical purposes<br>that is worn on the examiner's<br>hand to prevent contamination<br>between patient and examiner.<br>These gloves were tested for use<br>with chemotherapy drugs,<br>fentanyl citrate and gastric acid<br>as listed on the label. | The device is a disposable<br>device intended for medical<br>purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient<br>and examiner.<br>These gloves were tested for<br>use with chemotherapy drugs<br>and fentanyl citrate listed on<br>the label. | Similar<br>Adding Gastric Acid<br>Claim |
| Technological<br>Characteristics | The glove is a colored, nitrile,<br>powder-free, textured fingertip,<br>ambidextrous, patient<br>examination glove. | The glove is a colored, nitrile,<br>powder-free, textured fingertip,<br>ambidextrous, patient<br>examination glove. | Same |
| Sizes of gloves | XS, S, M, L, XL | XS, S, M, L, XL | Same |
| Glove Length | PureZero MARIN Nitrile Powder-<br>Free Exam Gloves with<br>Chemotherapy Drugs, Fentanyl<br>Citrate and Gastric Acid claim is<br>9.5 inches in length<br>PureZero MARIN-XTRA Nitrile<br>Powder-Free Exam Gloves with<br>Chemotherapy Drugs, Fentanyl<br>Citrate and Gastric Acid claim<br>is 12 inches in length | Halyard Purple Nitrile Powder-<br>Free Exam Glove with<br>Chemotherapy Drugs and<br>Fentanyl Citrate is 9.5 inches in<br>length | Similar<br>Adding a longer<br>length glove |
| Texture | Textured fingertips | Textured fingertips | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Shelf Life | 5 years | N/A | Different |
| Biocompatibility | Based on ISO 10993 Biological<br>evaluation of Medical devices –<br>Test for Systemic Injection, the<br>test article was considered non-<br>toxic. Meets the acceptance<br>criteria. | Based on ISO 10993 Biological<br>evaluation of Medical devices –<br>Test for Systemic Injection, the<br>test article was considered non-<br>toxic. Meets the acceptance<br>criteria. | Same |
| | Based on ISO 10993- Biological<br>evaluation of Medical Devices –<br>Test for Skin Irritation, the test<br>article was considered<br>nonirritating. Meets the<br>acceptance criteria. | Based on ISO 10993- Biological<br>evaluation of Medical Devices –<br>Test for Skin Irritation, the test<br>article was considered<br>nonirritating. Meets the<br>acceptance criteria. | |

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| Performance Data for Chemotherapy Drugs | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Standard | Results Subject Device(s)<br>K220547<br>PureZero MARIN Nitrile Powder-<br>Free Exam Gloves with<br>Chemotherapy Drugs, Fentanyl<br>Citrate and Gastric Acid claim<br>PureZero MARIN-XTRA Nitrile<br>Powder-Free Exam Gloves with<br>Chemotherapy Drugs, Fentanyl<br>Citrate and Gastric Acid claim | Results Predicate Device K200633<br>Halyard Purple Nitrile Powder-Free<br>Exam Glove with Chemotherapy<br>Drugs and Fentanyl Citrate claim | Remarks |
| ASTM D6978-05<br>Standard Practice<br>for Assessment of<br>Resistance of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy<br>Drugs | The following chemotherapy<br>drugs and concentration had NO<br>breakthrough<br>detected up to 240 minutes:<br>Cisplatin (1 mg/ml)<br>Cyclophosphamide (20 mg/ml)<br>Dacarbazine (10 mg/ml)<br>Doxorubicin HCI (2 mg/ml)<br>Etoposide (20 mg/ml)<br>Fluorouracil (50 mg/ml)<br>Ifosfamide (50 mg/ml)<br>Methotrexate (25 mg/ml)<br>Mitomycin C (0.5 mg/ml)<br>Mitoxantrone HCI (2 mg/ml)<br>Paclitaxel (6 mg/ml)<br>Vincrinstine Sulfate (1 mg/ml)<br>Fentanyl Citrate Injection (100<br>mcg/2 mL)<br>Simulated Gastric Acid<br>Fluid/Fentanyl Citrate Injection<br>Mix 50/50 Solution<br>The following chemotherapy<br>drugs and concentration<br>showed breakthrough detected<br>in less than 90 minutes: | The following chemotherapy drugs<br>and concentration had NO<br>breakthrough<br>detected up to 240 minutes:<br>Bleomycin (15.0 mg/ml)<br>Busulfan (6.0 mg/ml)<br>Carboplatin (10.0 mg/ml)<br>Cisplatin (1.0 mg/ml)<br>Cyclophosphamide (20.0 mg/ml)<br>Cytarabine (100.0 mg/ml)<br>Dacarbazine (DTIC) (10.0 mg/ml)<br>Daunorubicin (5.0 mg/ml)<br>Docetaxel (10.0 mg/ml)<br>Doxorubicin Hydrochloride (2.0<br>mg/ml)<br>Ellence (2.0 mg/ml)<br>Etoposide (Toposar) (20.0 mg/ml)<br>Fludarabine (25.0 mg/ml)<br>Fluorouracil (50.0 mg/ml)<br>Gemcitabine (Gemzar) (38.0 mg/ml)<br>Idarubicin (1.0 mg/ml)<br>Ifosfamide (50.0 mg/ml)<br>Irinotecan (20.0 mg/ml)<br>Mechlorethamine HCl (1.0 mg/ml)<br>Melphalan (5.0 mg/ml)<br>Methotrexate (25.0 mg/ml)<br>Mitomycin C (0.5 mg/ml)<br>Mitoxantrone (2.0 mg/ml)<br>Paclitaxel (Taxol) (6.0 mg/ml) | Similar |

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| ThioTEPA (10 mg/ml),<br>breakthrough detected at 88.6<br>minutes<br><br>The following chemotherapy<br>drugs and concentration<br>showed breakthrough detected<br>in less than 60 minutes:<br><br>Carmustine (3.3 mg/ml),<br>breakthrough detected at 55.2<br>minutes<br><br>Warning: Do not use with<br>Carmustine or ThioTEPA | Paraplatin (10.0 mg/ml)<br>Rituximab (10.0 mg/ml)<br>Trisonex (1.0 mg/ml)<br>Vincrinstine (1mg/ml)<br><br>Fentanyl Citrate, 100 mcg/2ml<br><br>The following drugs showed<br>breakthrough detected in less than<br>30 minutes:<br><br>Carmustine (3.3mg/ml) 1.8 minutes<br>ThioTEPA (10.0mg/ml): 1.7 minutes.<br>Warning- Not for use with<br>Carmustine and ThioTEPA |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| | Performance Data | | |
|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| ASTM D5151-06<br>Standard Test<br>Method for<br>Detection of Holes<br>in Medical Gloves | Testing of the subject device shows<br>it meets the 2.5% AQL requirement<br>in the standards for leakage. The<br>device meets the acceptance<br>criteria of the standard. | Testing of the subject device shows<br>it meets the 2.5% AQL requirement<br>in the standards for leakage. The<br>device meets the acceptance<br>criteria of the standard. | Same |
| ASTM D6124-06<br>Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves | Residual powder on the subject<br>device is an average of 0.4<br>mg/glove within the powder-free<br>limit of $< 2$ mg maximum powder<br>per glove and meets the<br>acceptance criteria for powder-<br>free. | Residual powder on the subject<br>device is an average of 0.4 mg/glove<br>within the powder-free limit of $< 2$<br>mg maximum powder per glove and<br>meets the acceptance criteria for<br>powder- free. | Same |
| ASTM D6319-10<br>Standard<br>Specification for<br>Nitrile Examination<br>Gloves for Medical<br>Applications | The physical dimensions of the<br>subject device are within the limits<br>of the standard and the physical<br>properties of the subject device<br>met the requirements for tensile<br>strength before and after aging. | The physical dimensions of the<br>predicate device are within the<br>limits of the standard and the<br>physical properties of the subject<br>device met the requirements for<br>tensile strength before and after<br>aging. | Same |
| ISO 10993 Biological<br>evaluation of<br>medical devices | Meets acceptance criteria | Meets acceptance criteria | Same |

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#### PERFORMANCE CHARACTERISTICS OF THE SUBJECT DEVICE

| Brief description<br>of non-clinical<br>tests: | Test | Standard | Acceptance Criteria | Results |
|------------------------------------------------|--------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Dimensions | ASTM D 6319 | | Meets<br>requirements |
| | | Length | 235 -250 mm (PureZero<br>MARIN Nitrile) | |
| | | | 295- 325 mm (PureZero<br>MARIN-XTRA Nitrile) | |
| | | Palm Width Size | XSmall: 60 – 80 mm<br>Small: 70 - 90 mm<br>Med: 85–105 mm<br>Large: 100 - 120 mm<br>X-Large: 110-130 mm | |
| | | Finger thickness<br>Palm thickness<br>Cuff thickness | 0.10-0.19 mm<br>0.10-0.16 mm<br>0.10-0.13 mm | |
| | | Physical Properties | ASTM D 6319 | AQL 4.0<br><br>Before<br>Tensile Strength: ≥14 MPa<br>Ultimate elongation: ≥500%<br><br>After<br>Tensile Strength: ≥14 MPa<br>Ultimate elongation: ≥400% |
| | | Freedom from<br>Pinholes | ASTM D 6319<br>ASTM D 5151 | AQL 2.5%<br>No leakage |
| | | Power Free | ASTM D 6124<br>ASTM D 6319 | ≤ 2 mg / glove |
| | | ISO Indirect<br>Irritation<br>Study | ISO 10993, Part 10 | Primary Irritation Index<br>≤2.0 |
| ISO Systemic<br>Toxicity<br>Study | ISO 10993, Part 11 | No animals treated with<br>test extracts exhibit<br>greater reaction than<br>control animals | No evidence of<br>systemic<br>toxicity | |
| ISO Dermal<br>Sensitization | ISO 10993, Part 10 | Grade < 1 | Under the<br>conditions<br>of the study<br>the device is<br>not a<br>sensitizer | |

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| Conclusion: | The conclusions drawn from the nonclinical and clinical tests demonstrate that the<br>subject device PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Drugs, Fentanyl Citrate and Gastric Acid claim and PureZero MARIN-XTRA Nitrile Powder- |
| | Free Exam Glove with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim, are as |
| | safe, as effective, and performs as well as or better than the legally marketed devices |
| | cleared under K200633. |