Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)

K200960 · Medline Industires, Inc. · LZA · Jul 13, 2020 · General Hospital

Device Facts

• Record ID: K200960
• Device Name: Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)
• Applicant: Medline Industires, Inc.
• Product Code: LZA · General Hospital
• Decision Date: Jul 13, 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.

Device Story

Disposable, non-sterile, ambidextrous nitrile examination gloves; dark blue color; beaded cuff. Used by healthcare examiners to prevent cross-contamination. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Output is a physical barrier; healthcare providers use gloves during patient examinations and chemotherapy handling. Benefits include protection against patient-to-examiner contamination and chemical exposure (excluding Carmustine and Thiotepa).

Clinical Evidence

Bench testing only. No clinical data. Performance evaluated per ASTM D6319-10 (physical properties), ASTM D6124-06 (residual powder), ASTM D5151-06 (freedom from holes), and ASTM D6978-05 (chemotherapy drug permeation). Biocompatibility testing performed per ISO 10993-10 (irritation/sensitization), ISO 10993-05 (cytotoxicity), and ISO 10993-11 (systemic toxicity).

Technological Characteristics

Material: Nitrile. Form: Powder-free, ambidextrous, beaded cuff. Standards: ASTM D6319-10 (physical properties), ASTM D6978-05 (chemotherapy permeation), ASTM D5151-06 (holes), ASTM D6124-06 (residual powder). Biocompatibility: ISO 10993-5, -10, -11. Non-sterile, single-use.

Indications for Use

Indicated for use as a disposable patient examination glove worn by examiners to prevent cross-contamination between patient and examiner. Tested for use with chemotherapy drugs.

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 Powder Free Blue Nitrile Examination Glove (Tested for use with Chemotherapy Drugs) (K051378)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medline Industries, Inc. Adam Ostrower Regulatory Affairs Sr. Specialist Three Lakes Drive Northfield, Illinois 60093

Re: K200960

Trade/Device Name: Medline Nitrile Powder Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 7, 2020 Received: April 10, 2020

Dear Mr. Ostrower:

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 and Part 809); 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,

Elizabeth F. Claverie, MS 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) K200960

#### Device Name

Medline Nitrile Powder Free Dark Blue Examination Gloves (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.

Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug | Concentration | Breakthrough time |
|----------------------------------------|--------------------------|-------------------|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 12.4 minutes |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | >240 minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | >240 minutes |
| Dacarbazine (DTIC) | 10.0 mg/ml (10,000 ppm) | >240 minutes |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | >240 minutes |
| Etoposide (Toposar) | 20.0 mg/ml (20,000 ppm) | >240 minutes |
| Fluorouracil | 50.0 mg/ ml (50,000 ppm) | >240 minutes |
| Methotrexate | 25 mg/ml (25,000 ppm) | >240 minutes |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 minutes |
| Paclitaxel (Taxol) | 6.0 mg/ml (6,000 ppm) | >240 minutes |
| ThioTepa | 10.0 mg/ml (10,000 ppm) | 27.4 minutes |
| Vincristine Sulfate (Oncovin) | 1.0 mg/ml (1,000 ppm) | >240 minutes |
| Do Not Use with Carmustine or 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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K200960

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

## Submitter / 510(k) Sponsor

Medline Industries. Inc. Three Lakes Drive Northfield, IL 60093

Registration Number: 1417592

## Contact Person

Adam Ostrower Regulatory Affairs Sr. Specialist Phone: [phone] Email: [e-mail]

Summary Preparation Date July 10th , 2020

Type of 510(k) Submission Traditional

#### Device Name / Classification

Trade Name: Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs) Common Name: Non-powdered patient examination glove Classification Name: Medical Gloves with Chemotherapy Labeling Claims – Test For Use with Chemotherapy Drugs Product Code: LZA. LZC Classification Panel: General Hospital Regulatory Class: Class I Regulation Number: 21 CFR 880.6250

#### Predicate Device

Medline Powder Free Blue Nitrile Examination Glove (Tested for use with Chemotherapy Drugs) K051378

#### Device Description

The Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with Chemotherapy drugs) are nonsterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are dark blue, powder free, nitrile ambidextrous gloves with a beaded cuff. The gloves are offered in sizes small, medium, large, and extra extra extra large packaged in a chipboard box.

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K200960

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

The Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with Chemotherapy drugs) are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

| Chemotherapy Drug | Concentration | Breakthrough time |
|-------------------------------|-------------------------|-------------------|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 12.4 minutes |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | >240 minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | >240 minutes |
| Dacarbazine (DTIC) | 10.0 mg/ml (10,000 ppm) | >240 minutes |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | >240 minutes |
| Etoposide (Toposar) | 20.0 mg/ml (20,000 ppm) | >240 minutes |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | >240 minutes |
| Methotrexate | 25 mg/ml (25,000 ppm) | >240 minutes |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 minutes |
| Paclitaxel (Taxol) | 6.0 mg/ml (6,000 ppm) | >240 minutes |
| ThioTepa | 10.0 mg/ml (10,000 ppm) | 27.4 minutes |
| Vincristine Sulfate (Oncovin) | 1.0 mg/ml (1,000 ppm) | >240 minutes |

Do Not Use with Carmustine or Thiotepa

#### Summary of Technological Characteristics Table 2: Comparison of Proposed and Predicate Devices

| Device<br>Characteristic | Proposed Device | Predicate Device | Comparison<br>Analysis |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Medline Nitrile Powder Free Dark Blue<br>Examination Gloves (Tested for use with<br>Chemotherapy Drugs) | Medline Powder Free Blue Nitrile Examination Glove<br>(Tested for use with Chemotherapy Drugs) | N/A |
| 510(k) Reference | K200960 | K051378 | N/A |
| Product Owner | Medline | Medline | Same |
| Product Code | LZA, LZC | LZA | Similar |
| Intended Use | A patient examination glove is a disposable device<br>intended for medical purposes that is worn on the<br>examiner's hand to prevent contamination between<br>patient and examiner. These gloves were tested for<br>use with chemotherapy drugs. | A patient examination glove is a disposable device<br>intended for medical purposes that is worn on the<br>examiner's hand to prevent contamination between<br>patient and examiner. | Similar |
| Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Design<br>Configurations | Dark Blue | Blue | Similar |
| Materials | Nitrile | Nitrile | Same |
| Prescription vs.<br>OTC | OTC | OTC | Same |
| Contact<br>Durations | Limited < 24 hours | Limited < 24 hours | Same |
| Sterile vs. Non-<br>Sterile | Non-Sterile | Non-Sterile | Same |
| Disposable vs.<br>Non-Disposable | Disposable | Disposable | Same |
| Single Use vs.<br>Reusable | Single Use | Single Use | Same |
| Dimensions-<br>Width | Complies with:<br>ASTM D6319-10<br>70mm min | Complies with:<br>ASTM D6319-10<br>70mm min | Same |
| Dimensions-<br>Thickness | Complies with:<br>ASTM D6319-10<br>Palm - 0.05mm min.<br>Finger - 0.05mm min. | Complies with:<br>ASTM D6319-10<br>Palm - 0.05mm min.<br>Finger - 0.05mm min. | Same |
| Physical<br>Properties | Complies with:<br>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:<br>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<br>holes | Complies with:<br>ASTM D6319-10 and<br>ASTM D5151-06 G-1,<br>AQL 1.5 | Complies with:<br>ASTM D6319-10 and<br>ASTM D5151-06 G-1.<br>AQL 1.5 | Same |
| Powder or<br>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 |
| Biocompatibility | Complies with AAMI/ANSI/ISO 10993-10:<br>Not a skin irritant<br>Not a skin sensitizer<br>AAMI/ANSI/ISO 10993-05<br>ISO 10993-11:<br>Non-Toxic | Complies with AAMI/ANSI/ISO 10993-10:<br>Not a skin irritant<br>Not a skin sensitizer | Similar |

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| Chemotherapy<br>Drugs Tested<br>with Minimum<br>Breakthrough<br>Detection Time<br>as tested per<br>ASTM D6978 | Chemotherapy<br>Drug | Concentration | Breakthrough<br>time | | Chemotherapy<br>Drug | Concentration | Breakthrough time | Similar |
|---------------------------------------------------------------------------------------------------------------|----------------------------------------|----------------------------|----------------------|--|------------------------------|----------------------------|--------------------------------------|---------|
| | Carmustine<br>(BCNU) | 3.3 mg/ml<br>(3,300 ppm) | 12.4 minutes | | | | | |
| | Cisplatin | 1.0 mg/ml<br>(1,000 ppm) | >240 minutes | | Cyclophosphamide | 20.0 mg/ml<br>(20,000 ppm) | No breakthrough up to<br>240 minutes | |
| | Cyclophosphamide<br>(Cytoxan) | 20.0 mg/ml<br>(20,000 ppm) | >240 minutes | | Doxorubicin<br>Hydrochloride | 2.0 mg/ml<br>(2,000 ppm) | No breakthrough up to<br>240 minutes | |
| | Dacarbazine<br>(DTIC) | 10.0 mg/ml<br>(10,000 ppm) | >240 minutes | | Etoposide | 20.0 mg/ml<br>(20,000 ppm) | No breakthrough up to<br>240 minutes | |
| | Doxorubicin<br>Hydrochloride | 2.0 mg/ml<br>(2,000 ppm) | >240 minutes | | Fluorouracil | 50.0 mg/ml<br>(50,000 ppm) | No breakthrough up to<br>240 minutes | |
| | Etoposide<br>(Toposar) | 20.0 mg/ml<br>(20,000 ppm) | >240 minutes | | Paclitaxel (Taxol) | 6.0 mg/ml<br>(6,000 ppm) | No breakthrough up to<br>240 minutes | |
| | Fluorouracil | 50.0 mg/ml<br>(50,000 ppm) | >240 minutes | | Cisplatin | 1.0 mg/ml<br>(1,000 ppm) | No breakthrough up to<br>240 minutes | |
| | Methotrexate | 25 mg/ml<br>(25,000 ppm) | >240 minutes | | Dacarbazine | 10.0 mg/ml<br>(10,000 ppm) | No breakthrough up to<br>240 minutes | |
| | Mitomycin C | 0.5 mg/ml (500 ppm) | >240 minutes | | Methotrexate | 25 mg/ml<br>(25,000 ppm) | No breakthrough up to<br>240 minutes | |
| | Paclitaxel (Taxol) | 6.0 mg/ml<br>(6,000 ppm) | >240 minutes | | Carmustine | 3.3 mg/ml<br>(3,300 ppm) | Not for use with<br>Camustine | |
| | Thio Tepa | 10.0 mg/ml<br>(10,000 ppm) | 27.4 minutes | | ThioTepa | 10.0 mg/ml<br>(10,000 ppm) | Not for use with<br>Thiotepa | |
| | Vincristine Sulfate<br>(Oncovin) | 1.0 mg/ml<br>(1,000 ppm) | >240 minutes | | | | | |
| | Do Not Use with Carmustine or Thiotepa | | | | | | | |

#### Summary of Non-Clinical Testing

The biocompatibility evaluation for the Medline Nitrile Powder Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs) was conducted in accordance with ANSVAAMI/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 the Medline Nitrile Powder Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs)

- · ISO 10993-10: Primary Skin Irritation
- · ISO 10993-10: Dermal Sensitization
- · ISO 10993-05: Cytotoxicity
- · ISO 10993-11: Systemic Toxicity

#### 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. 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.

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To summarize, the performance testing of the subject device were conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:

ASTM D 6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D 6124-06 (Reaffirmation 2017) Standard Test Method for Residual Powder on Medical Gloves ASTM D 5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves ASTM D 6978-05 (Reapproved 2013) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

#### Conclusion

In accordance with 21 CFR part 807, and based on the non-clinical testing and information provided in this premarket notification Medline Industries, Inc. concludes that the Medline Nitrile Powder Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicated device, Medline Powder Free Blue Nitrile Examination Glove (Tested for use with Chemotherapy Drugs) K051378.