Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)

K192315 · Medline Industries, Inc. · LZA · Jan 10, 2020 · General Hospital

Device Facts

• Record ID: K192315
• Device Name: Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
• Applicant: Medline Industries, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Jan 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable, non-sterile, ambidextrous nitrile examination gloves; feature inner coating of colloidal oatmeal USP. Used by healthcare examiners to prevent cross-contamination. Tested for permeation resistance against various chemotherapy drugs per ASTM D6978-05. Output is a physical barrier; healthcare providers use gloves during patient examinations or chemotherapy drug handling to protect both patient and examiner from contamination. Benefits include barrier protection and potential skin-soothing properties from oatmeal coating.

Clinical Evidence

Bench testing only. No clinical data. Performance evaluated via ASTM D6319-10 (physical dimensions, tensile strength, elongation), ASTM D6124-06 (residual powder), ASTM D5151-06 (freedom from holes), and ASTM D6978-05 (chemotherapy drug permeation). Biocompatibility tested per ISO 10993-1, -5, -10, and -11.

Technological Characteristics

Nitrile material with colloidal oatmeal USP coating (min 5mg/glove). Ambidextrous, beaded cuff, powder-free. Sizes: XS-XL. Complies with ASTM D6319-10 for physical dimensions and properties. Non-sterile. Biocompatibility: ISO 10993-1 compliant (non-irritant, non-sensitizer, non-systemic toxic).

Indications for Use

Indicated for use as a disposable medical glove worn by examiners to prevent cross-contamination between patient and examiner. Suitable for use with specific chemotherapy drugs as tested per ASTM D6978-05.

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

• Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) (K180696)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 10, 2020

Medline Industries, Inc. Claire Pigman Associate Manager, Regulatory Affairs Three Lakes Drive Northfield, Illinois 60093

Re: K192315

Trade/Device Name: Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: December 6, 2019 Received: December 10, 2019

Dear Claire Pigman:

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

Sincerely.

For 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) K192315

#### Device Name

Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for use with Chemotherapy Drugs)

#### Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Blenoxane (Bleomycin) 15.0 mg/ml >240 minutes Bortezomib 1.0 mg/ml >240 minutes Busulfan 6.0 mg/ml >240 minutes Carboplatin 10.0 mg./ml >240 minutes Carmustine (BCNU) 3.3 mg/ml 13.2 minutes Cetuximab (Eributux) 2.0 mg/ml >240 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Docetaxel 10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Epirubicin (Ellence) 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fludarabine 25.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Gemcitabine (Gemzar) 38.0 mg/ml >240 minutes Idarubicin 1.0 mg/ml >240 minutes Ifosfamide 50.0 mg/ml >240 minutes Irinotecan 50.0 mg/ml >240 minutes Mechlorethamine HCI 1.0 mg/ml >240 minutes Melphalan 5.0 mg/ml >240 minutes Methotrexate 25.0 mg/ml >240 minutes Mitomycin C 0.5 mg/ml >240 minutes Mitoxantrone 2.0 mg/ml >240 minutes Oxaliplatin 5.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Paraplatin 10.0 mg/ml >240 minutes Pemetrexed 25.0 mg/ml >240 minutes Raltitrexed 0.5 mg/ml >240 minutes Rituximab 10.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 44 minutes Trisonex (Arsenic Trioxide) 1.0 mg/ml >240 minutes Vidaza (Azacitidine) 25.0 mg/ml >240 minutes Vinblastine 1.0 mg/ml >240 minutes Vincristine Sulfate 1.0 mg/ml >240 minutes Vinorelbine 10.0 mg/ml >240 minutes

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Please note that the following drug has extremely low permeation time: Carmustine (BCNU) (3.3 mg/ml) 13.2 minutes Please note that the following drug has extremely low permeation time: Thiotepa (10.0 mg/ml) 44.0 minutes

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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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is in white, block letters, and to the right of the word is a white, stylized star shape. The star has four points, with the bottom point extending further down than the other three.

# K192315 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92]

## Submitter / 510(k) Sponsor

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592

# Contact Person

Claire Pigman Associate Manager, Regulatory Affairs Phone: [phone] Email: [e-mail]

Summary Preparation Date January 9, 2020

Type of 510(k) Submission Traditional

## Device Name / Classification

Name of Device: Patient Examination Glove (Tested for Use with Chemotherapy Drugs) Proprietary Name: Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for use with Chemotherapy Drugs) Common Name: Patient Examination Glove Classification Name: Patient Examination Glove Product Code: LZA, LZC Classification Panel: General Hospital Regulation #: 21 CFR 880.6250

## Predicate Device

Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) - K180696

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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, with a stylized white starburst symbol above it. The starburst has four points, resembling a compass rose.

#### Device Description

There have been no changes to the Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs). The materials of construction, colorant, sizes and product specifications have not changed and are identical to what was cleared under K180696. The only change is to the Indications for Use.

As previously described in K180696, the Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for use with Chemotherapy Drugs) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are powder-free, ambidextrous with beaded cuff, green colored nitrile gloves featuring an inner coating of colloidal oatmeal USP. The gloves are offered in five sizes, extra-small, small, medium, large and extra-large.

The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013).

#### Indications for Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Blenoxane (Bleomycin) 15.0 mg/ml >240 minutes Bortezomib 1.0 mg/ml >240 minutes Busulfan 6.0 mg/ml >240 minutes Carboplatin 10.0 mg./ml >240 minutes Carmustine (BCNU) 3.3 mg/ml 13.2 minutes Cetuximab (Eributux) 2.0 mg/ml >240 minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 minutes Dacarbazine (DTIC)10.0 mg/ml >240 minutes Docetaxel 10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Epirubicin (Ellence) 2.0 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fludarabine 25.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Gemcitabine (Gemzar) 38.0 mg/ml >240 minutes Idarubicin 1.0 mg/ml >240 minutes Ifosfamide 50.0 mg/ml >240 minutes Irinotecan 50.0 mg/ml >240 minutes

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Image /page/6/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, block letters. A white, stylized starburst symbol is behind the text, with the word "MEDLINE" centered on the starburst.

Mechlorethamine HCI 1.0 mg/ml >240 minutes Melphalan 5.0 mg/ml >240 minutes Methotrexate 25.0 mg/ml >240 minutes Mitomycin C 0.5 mg/ml >240 minutes Mitoxantrone 2.0 mg/ml >240 minutes Oxaliplatin 5.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Paraplatin 10.0 mg/ml >240 minutes Pemetrexed 25.0 mg/ml >240 minutes Raltitrexed 0.5 mg/ml >240 minutes Rituximab 10.0 mg/ml >240 minutes Thiotepa 10.0 mg/ml 44 minutes Trisonex (Arsenic Trioxide) 1.0 mg/ml >240 minutes Vidaza (Azacitidine) 25.0 mg/ml >240 minutes Vinblastine 1.0 mg/ml >240 minutes Vincristine Sulfate 1.0 mg/ml >240 minutes Vinorelbine 10.0 mg/ml >240 minutes

Please note that the following drug has extremely low permeation time: Carmustine (BCNU) (3.3 mg/ml) 13.2 minutes Please note that the following drug has extremely low permeation time: Thiotepa (10.0 mg/ml) 44.0 minutes

# Summary of Technological Characteristics

| Device Characteristic | Proposed Device | Predicate Device | Comparison Analysis |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Product Name | Medline Green Ambidextrous<br>Powder-Free Nitrile Examination<br>Gloves with Colloidal Oatmeal<br>USP (Tested for use with<br>Chemotherapy Drugs) | Medline Green Ambidextrous<br>Powder-Free Nitrile Examination<br>Gloves with Colloidal Oatmeal<br>USP (Tested for use with<br>Chemotherapy Drugs) | Same |
| 510(k) Reference | K192315 | K180696 | N/A |
| Product Owner | Medline Industries, Inc. | Medline Industries, Inc. | Same |
| Product Code | LZA, LZC | LZA, LZC | Same |
| Intended Use | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand to prevent | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand to prevent | Same |
| contamination between patient and examiner.<br>These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs | | contamination between patient and examiner.<br>These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs | |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Materials | Nitrile<br>Colloidal oatmeal | Nitrile<br>Colloidal oatmeal | Same |
| Color | Green | | Same |
| Sizes | x- small, small, medium, large, x-large | x-small, small, medium, large, x-large | Same |
| Dimensions - Length | Complies with ASTM D6319-10<br>220mm min. | Complies with ASTM D6319-10<br>230mm min. | Same |
| Dimensions - Width | Complies with ASTM D6319-10<br>X-small – 70±10mm<br>Small – 80±10mm<br>Medium – 95±10mm<br>Large – 110±10mm<br>X-large – 120±10mm | Complies with ASTM D6319-10<br>X-small – 70±10mm<br>Small – 80±10mm<br>Medium – 95±10mm<br>Large – 110±10mm<br>X-large – 120±10mm | Same |
| Dimensions - Thickness | Complies with ASTM D6319-10<br>Palm – 0.05mm min.<br>Finger – 0.05mm min. | Complies with ASTM D6319-10<br>Palm – 0.05mm min.<br>Finger – 0.05mm min. | Same |
| Physical Properties | Complies with ASTM D6319-10 minimum:<br>Tensile Strength:<br>Before Aging ≥14 MPa, min.<br>After Aging ≥14 MPa, min.<br>Elongation:<br>Before Aging 500%, min.<br>After Aging 400%, min. | Complies with ASTM D6319-10 minimum:<br>Tensile Strength:<br>Before Aging ≥14 MPa, min.<br>After Aging ≥14 MPa, min.<br>Elongation:<br>Before Aging 500% min.<br>After Aging 400% min. | Same |
| Freedom from Holes | Complies with ASTM D6319-10 and ASTM D5151-06 G-1, AQL 1.5 | Complies with ASTM D6319-10 and ASTM D5151-06 G-1, AQL 1.5 | Same |
| Powder or Powder-Free | Powder-Free | Powder-Free | Same |
| Residual Powder | Complies with ASTM D6319-10<br><2mg per glove | Complies with ASTM D6319-10<br><2mg per glove | Same |
| Colloidal Oatmeal<br>Content | Minimum 5mg per glove for all sizes | | Same |
| Contact Durations | Limited <24 hours | | Same |
| Biocompatibility per<br>ISO 10993-1 | Not a skin irritant<br>Not a skin sensitizer<br>At the neat extraction, the test<br>article is considered cytotoxic, but<br>the acute systemic toxicity results<br>demonstrate the device will not<br>cause a systemic effect. | Not a skin irritant<br>Not a skin sensitizer<br>Not tested against cytotoxicity | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Chemotherapy Drugs<br>Tested with Minimum<br>Breakthrough<br>Detection Time as<br>tested per ASTM<br>D6978 | Blenoxane (Bleomycin)<br>15 mg/ml >240 min. | | Similar |
| | Bortezomib 1 mg/ml<br>>240 min. | | Similar |
| | Busulfan 6 mg/ml<br>>240 min. | | Similar |
| | Carboplatin 10 mg/ml<br>>240 min. | | Similar |
| | Carmustine (BCNU) 3.3 mg/ml<br>>240 min. | Carmustine (BCNU) 3.3 mg/ml<br>13.2 min. | Same |
| | Cetuximab (Erbitux) 2 mg/ml >240<br>min. | | Similar |
| | Cisplatin 1.0 mg/ml<br>>240 min. | Cisplatin 1.0 mg.ml<br>>240 min. | Same |
| | Cyclophosphamide (Cytoxan) 20<br>mg/ml<br>>240 min. | Cyclophosphamide (Cytoxan) 20.0<br>mg/ml<br>>240 min. | Same |
| | Dacarbazine (DTIC)10.0 mg/ml<br>>240 min. | Dacarbazine (DTIC)10.0 mg/ml<br>>240 min. | Same |
| | Docetaxel 10.0 mg/ml<br>>240 min. | | Similar |
| | Doxorubicin Hydrochloride 2.0<br>mg/ml >240 min. | Doxorubicin Hydrochloride 2.0<br>mg/ml >240 min. | Same |
| | Epirubicin (Ellence) 2.0 mg/ml<br>>240 min. | | Similar |
| | Etoposide (Toposar) 20.0 mg/ml<br>>240 min. | Etoposide (Toposar) 20.0 mg/ml<br>>240 min. | Same |
| | Fludarabine 25 mg/ml<br>>240 min. | | Similar |
| | Fluorouracil 50.0 mg/ml<br>>240 min. | Fluorouracil 50.0 mg/ml<br>>240 min. | Same |
| Gemcitabine (Gemzar) 38 mg/ml<br>>240 min. | | Similar | |
| Idarubicin 1 mg/ml<br>>240 min. | | Similar | |
| Ifosfamide 50.0 mg/ml<br>>240 min. | | Similar | |
| Irinotecan 20.0 mg/ml<br>>240 min. | | Similar | |
| Mechlorethamine HCI 1.0 mg/ml<br>>240 min. | | Similar | |
| Melphalan 5 mg/ml<br>>240 min. | | Similar | |
| Methotrexate 25 mg/ml<br>>240 min. | Methotrexate 25 mg/ml<br>>240 min. | Same | |
| Mitromycin C. 0.5 mg/ml >240 | Mitromycin C. 0.5 mg/ml >240 | Same | |
| Mitoxantrone 2.0 mg/ml<br>>240 min. | | Similar | |
| Oxaliplatin 5 mg/ml<br>>240 min. | | Similar | |
| Paclitaxel (Taxol) 6.0 mg/ml<br>>240 min. | Paclitaxel (Taxol) 6.0 mg/ml<br>>240 min. | Same | |
| Paraplatin 10 mg/ml<br>>240 min. | | Similar | |
| Pemetrexed Disodium 25 mg/ml<br>>240 min. | | Similar | |
| Raltitrexed 0.5 mg/ml<br>>240 min. | | Similar | |
| Rituximab 10 mg/ml<br>>240 min. | | Similar | |
| Thiotepa 10.0 mg/ml<br>44.0 min. | Thiotepa 10.0 mg/ml<br>44.0 min. | Same | |
| Trisonex 0.1 mg/ml<br>>240 min. | | Similar | |
| Vidaza (5-Azacytidine) 25 mg/ml<br>>240 min | | Similar | |
| Vinblastine 1 mg/ml<br>>240 min. | | Similar | |
| Vinorelbine 10 mg/ml<br>>240 min. | | Similar | |
| Vincristine Sulfate 1.0 mg/ml >240<br>min. | Vincristine Sulfate 1.0 mg/ml<br>>240 min. | Same | |

Table 1 Comparison of Proposed and Predicate Device

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Image /page/7/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in white, block letters on the left side of the square. To the right of the word is a white, stylized starburst symbol.

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Image /page/8/Picture/0 description: The image features the Medline logo, which is set against a blue square background. The word "MEDLINE" is prominently displayed in white, sans-serif font, positioned to the left of a stylized white starburst symbol. The starburst has four points, resembling a compass rose, and it is oriented diagonally within the square.

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Image /page/9/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized starburst symbol. The starburst is composed of four white, elongated triangles converging at a central point, creating a dynamic and modern design.

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Image /page/10/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized white starburst symbol. The starburst is oriented diagonally, with its points extending beyond the text, creating a dynamic and recognizable brand mark.

# Summary of Non-Clinical Testing

#### Biocompatibility

The biocompatibility evaluation for Medline Green Ambidextrous Powder-Free Nitrile Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) was conducted in accordance with ANSI/AAMI/ISO 10993-1:2018 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA.

The following tests were performed to evaluate the biocompatibility of Medline Green Ambidextrous Powder-Free Nitrile Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs):

| Test<br>Standard | Test Standard<br>Description | Acceptance Criteria | Result |
|------------------|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| ISO 10993-10 | Primary Skin Irritation | Cutaneous macroscopical examinations are<br>performed after removal of test material. The<br>appearance of each application site and skin<br>reaction observed are scored. | No skin reactions<br>observed. Not a skin<br>irritant. |
| ISO 10993-10 | Dermal Sensitization | Challenge sites are visually assessed for allergic<br>reactions and the intensity of the reaction is<br>scored. | No positive allergic<br>reactions observed. Not<br>a skin sensitizer |
| ISO 10993-5 | Cytotoxicity | Test articles scoring '0', '1', or '2' are<br>considered 'non-cytotoxic.' Test articles<br>scoring '3' or '4' are considered 'cytotoxic.' | At the neat extraction,<br>the test article is<br>considered cytotoxic. |
| ISO 10993-11 | Acute Systemic Toxicity | Abnormal clinical signs indicative of toxicity<br>during the 72 hours test period are observed and<br>reported. | No signs of toxicity at<br>any of the observation<br>periods were observed. |

#### Table 2 Biocompatibility Testing Summary

# Performance Testing (Bench)

Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. Additionally, permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2013), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs. To summarize, the following tests were performed to evaluate the functional performance of the subject device:

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Image /page/11/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in white, block letters on the left side of the square. To the right of the word is a white, stylized star shape that is oriented vertically.

## Table 3 Performance Testing Summary

| Test Standard | Test Standard Description | Acceptance Criteria | Result |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| ASTM D6319-10 | Standard Specification for<br>Nitrile Examination Gloves for<br>Medical Application | Samples shall meet specified<br>physical dimensions in accordance<br>with the standard. | All device dimensions<br>meet the standard. |
| ASTM D6124-06<br>(Reaffirmation<br>2011) | Standard Test Method for<br>Residual Powder on Medical<br>Gloves | < 2mg of residual powder per glove. | Complies with<br>standard. |
| ASTM D5151-06<br>(Reapproved<br>2011) | Standard Test Method for<br>Detection of Holes in Medical<br>Gloves | Any glove that shows a droplet,<br>stream or other type of water<br>leakage shall be considered to have<br>failed. | Complies with<br>standard. |
| ASTM D6978-05<br>(Reapproved<br>2013) | Standard Practice for<br>Assessment of Resistance of<br>Medical Gloves to Permeation<br>by Chemotherapy Drugs | The absorbance of test chemicals,<br>which permeate through the test<br>articles, is measured and reported. | Refer to Table 1 above. |

# Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device (K180696).