Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)

K213227 · Uweport, LLC · LZA · Jan 19, 2022 · General Hospital

Device Facts

• Record ID: K213227
• Device Name: Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)
• Applicant: Uweport, LLC
• Product Code: LZA · General Hospital
• Decision Date: Jan 19, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Uweport Powder-Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs is a nonsterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Non-sterile, single-use, disposable nitrile examination glove; worn by clinicians to prevent cross-contamination between patient and examiner. Manufactured from synthetic copolymer of acrylonitrile and butadiene with blue color additive. Features textured fingertips, beaded cuff, and straight fingers. Tested per ASTM D6978-05(2019) for permeation resistance against specific chemotherapy drugs. Used in clinical settings; provides barrier protection. Benefits patient and examiner by reducing exposure to contaminants and hazardous chemotherapy agents.

Clinical Evidence

No clinical data. Bench testing only. Testing included ASTM D6319-19 (physical properties), ASTM D5151-19 (freedom from holes), ASTM D6124 (residual powder), ASTM D6978-05(2019) (chemotherapy permeation), and ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation, systemic toxicity).

Technological Characteristics

Material: Nitrile (synthetic copolymer of acrylonitrile and butadiene). Design: Ambidextrous, textured fingertips, beaded cuff. Standards: ASTM D6319-19 (physical properties), ASTM D5151-19 (holes), ASTM D6124 (residual powder), ASTM D6978-05(2019) (chemotherapy permeation). Biocompatibility: ISO 10993-5, 10993-10, 10993-11. Non-sterile, single-use.

Indications for Use

Indicated for use as a non-sterile, single-use, disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner. Tested for resistance to chemotherapy drug permeation per ASTM D6978-05(2019).

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

• Harbour Health Powder Free Nitrile Examination Glove, Blue (K210944)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 19, 2022

Uweport LLC. % Elaine Duncan President Paladin Medical, Inc P.O. Box 560 Stillwater, Minnesota 55082

Re: K213227

Trade/Device Name: Uweport Powder-Free Nitrile 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, LZC, OPJ Dated: December 17, 2021 Received: December 20, 2021

Dear Elaine Duncan:

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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for

combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K213227

Device Name

Uweport Powder-Free NITRILE EXAMINATION GLOVES Tested for Use with Chemotherapy Drugs

#### Indications for Use (Describe)

Uweport Powder-Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs is a nonsterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

| Drug Tested | Concentration | Breakthrough<br>Detection Time in<br>Minutes |
|----------------------------|-------------------------|----------------------------------------------|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 22.8 |
| Cisplatin | 1 mg/ml (1.000 ppm) | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | >240 |
| Dacarbazine | 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin | 2 mg/ml (2,000 ppm) | >240 |
| Etoposide | 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil | 50.0 mg/ml (50.000 ppm) | >240 |
| Paclitaxel, | 6 mg/ml (6,000 ppm) | >240 |
| ThioTepa, | 10.0 mg/ml (10,000 ppm) | 46.8 |

Warning: Not recommended for use with Carmustine and Thiotepa. The maximum testing time is 240 minutes. Please note that the following drugs have low permeation times:

Camustine (BCNL) 3.3 mg/ml (3,000 ppm) 22.8 minutes Thiotepa 10.0 mg/ml (10,000 ppm) 46.8 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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# 510(K) SUMMARY

| Submitter: | Uweport, LLC . |
|----------------------------|-------------------------------------------------------------------------------------------------------------------|
| Address: | 3623 Latrobe Drive Suite 201<br>Charlotte, NC 28211 |
| Contact | Mike Wang, President |
| Telephone: | 314 435-0587 |
| Email: | [e-mail] |
| 510(k) CONTACT: | Elaine Duncan, M.S.M.E., RAC<br>President, Paladin Medical, Inc.<br>PO Box 560<br>Stillwater, MN 55082 |
| Telephone: | 715-549-6035 |
| DATE PREPARED: | January 14, 2022 |
| PRODUCT NAME: | Uweport Powder-Free Nitrile Examination Gloves<br>Tested for Use with Chemotherapy Drugs |
| COMMON NAME: | Examination Glove |
| CLASSIFICATION NAME | Medical Gloves with Chemotherapy Labeling Claims<br>Test for use with Chemotherapy Drugs |
| CLASSIFICATION | Class I |
| PRO CODE: | LZA, OPJ, LZC |
| REGULATION | 21 CFR 880.6250 |
| PREDICATE NAME: | K210944 Harbour Health Powder Free Nitrile<br>Examination Glove, Blue (Tested for Use with<br>Chemotherapy Drugs) |
| DESCRIPTION of the DEVICE: | |

### DESCRIPTION

Uweport Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a non-sterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. These powder-free gloves are made of synthetic biocompatible copolymer of acrylonitrile and butadiene with a blue color additive. The gloves are available in small, medium, large, and extra-large.

### INDICATIONS FOR USE:

Uweport Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a non-sterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

ime in

List of Drugs tested concentration and breakthrough detection time in minutes.

| Drug Tested | Concentration | Breakthrough<br>Detection Time<br>Minutes |
|----------------------------|-------------------------|-------------------------------------------|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 22.8 |
| Cisplatin | 1 mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | >240 |
| Dacarbazine | 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin | 2 mg/ml (2,000 ppm) | >240 |
| Etoposide | 20 mg/ml (20,000 ppm) | >240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | >240 |
| Paclitaxel, | 6 mg/ml (6,000 ppm) | >240 |
| ThioTena | 10.0 mg/ml (10,000 ppm) | 46.8 |

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### 510(k) Summary-Continued

Warning: Not recommended for use with Carmustine and Thiotepa. The maximum testing time is 240 minutes. Please note that the following drugs have low permeation times: Camustine (BCNL) 3.3 mg/ml (3,000 ppm) 22.8 minutes
46.8 minutes Thio tepa 10.0 mg/ml (10,000 ppm)

#### Comparative Analysis to Predicate:

| Characteristic | Predicate Device | UWEPORT | ComparisonAnalysis |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Device Name | Harbour Health Powder<br>Free Nitrile Examination<br>Glove, Blue(Tested for<br>Use with Chemotherapy<br>Drugs) | Uweport Nitrile Exam Glove<br>(tested for use with<br>Chemotherapy Drugs) | |
| 510(k) Reference | K210944 | K213227 | |
| Product Code | LZA, LZC, OPJ | LZA, LZC, OPJ | Same |
| Indication for Use<br>(partial) | The Harbour Health<br>Powder Free Nitrile<br>Examination Glove, Blue<br>(Tested for Use with<br>Chemotherapy Drugs) is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's<br>hand to prevent<br>contamination between<br>patient and examiner. The<br>proposed device was tested<br>for use with chemotherapy<br>drugs per ASTM D6978-<br>05(2019), Standard Practice<br>for Assessment of Medical<br>Gloves to Permeation by<br>Chemotherapy Drugs | Uweport Powder-Free Nitrile<br>Exam Gloves Tested for Use<br>with Chemotherapy Drugs is a<br>non-sterile, 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 have been tested<br>for use with chemotherapy drugs<br>per ASTM D6978-05(2019)<br>Standard Practice for<br>Assessment of Resistance of<br>Medical Gloves to Permeation<br>by Chemotherapy Drugs. | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Design Features | Ambidextrous Textured<br>fingertipsBeaded cuff<br>Straight fingers | Ambidextrous<br>Textured fingertips<br>Beaded cuff Straight fingers | Similar |
| Sizes | Small, Medium,<br>Large, ExtraLarge | Small, Medium,Large,<br>Extra Large | Same |
| Dimension<br>Thickness | Complies with ASTM<br>D6319-19<br>Palm: 0.05mm min.<br>Finger: 0.05mm min. | Complies with ASTM<br>D6319-19<br>Palm: 0.07S; 0.08M;<br>0.08L, 0.08mmXL all<br>±0.03mm<br>Finger: 0.09 ± 0.03mm | Similar |
| Dimensions-Width | Complies with ASTM<br>D6319-19 | Complies with ASTM<br>D6319-19 | Similar |
| Characteristic | Predicate Device | UWEPORT | ComparisonAnalysis |
| | Medium:95± 10mm<br>Large:110± 10mm<br>Extra Large:120 ±10mm | Medium:96± 5mm<br>Large:108± 5mm<br>Extra large:115±5mm | |
| Dimensions Length | Complies with ASTM D6319-19<br>Small: 220mm min.<br>Medium/Large/Extra Large:<br>230mm- min | Complies with ASTM D6319-19<br>Small: ≥220mm.<br>Medium/Large/Extra<br>Large: ≥240mm | |
| Rx vs OTC | OTC | OTC | Same |
| Sterile vs<br>Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Disposable vs<br>Non-Disposable | Disposable | Disposable | Same |
| Biocompatibility | Complies with<br>ANSI/AAMI/ISO<br>10993-5 (2009)<br>* Under the conditions of the<br>study, the device is potentially<br>cytotoxic.<br>Complies with<br>ANSI/AAMI/ISO<br>10993-10 (2010)<br>* Under the conditions of the<br>study, the device is a nonirritant<br>and a non-sensitizer.<br>Complies with<br>ANSI/AAMI/ISO<br>10993-11 (2017)<br>* Under the conditions of the<br>study, the device does not elicit<br>a systemic toxicity response in<br>the model animal. | Cytotoxicity ISO 10993-5: At<br>100% extraction the cell viability<br>was 17.1%.<br>Sensitization ISO 10993-10 The<br>test article passed both extract<br>assays with a 0 score.<br>Irritation<br>ISO 10093-10<br>The test article from both extracts<br>was categorized as negligible under<br>the test conditions.<br>Acute Systemic Toxicity; ISO<br>10993-11:2017;<br>Under the conditions of the study<br>the test article extract met the<br>requirements of the study; Body<br>weight data and animal<br>appearance was normal<br>throughout the study. | Similar |
| Single Use vs<br>Reusable | Single Use | Single Use | Same |
| Physical<br>Properties<br>Tensile Strength | Complies with ASTM D6319-<br>19 Before Aging: >14 MPa<br>min. After Aging: >14 MPa,<br>min. | Complies with ASTM<br>D6319-19 at nominal<br>conditions ≥14 Mpa | Similar |
| Physical Properties<br>Elongation- | Complies with ASTM<br>D6319-19<br>Before Aging: 500% min.<br>After Aging:400% min. | Complies with ASTM<br>D6319-19 at nominal<br>conditions; ≥500 | similar |
| Freedom from<br>Holes | Complies with ASTM<br>D5151-19 and ASTM<br>D5151-19 G-1, AQL 2.5 | Complies with ASTM D5151-<br>19; AQL = 2.5, 125 samples<br>from batch of 35000,<br>inspection level 1, criterion ≤7<br>Zero nonconforming | Similar |
| Residual Powder | Complies with ASTM D6319-19<br>< 2 mg per glove | ASTM D6124 Standard Test<br>Method for Residual Powder On<br>Medical Gloves; residual powder<br>0.15; 0.18 and 0.19 mg/glove; | Similar |
| Characteristic | Predicate Device | UWEPORT | ComparisonAnalysis |
| Chemotherapy<br>Permeation | ASTM D6978-05(2019)<br>Assessment of Resistance of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy Drugs | ASTM D6978-05(2019)<br>Assessment of Resistance of<br>Medical Gloves to Permeation<br>by Chemotherapy Drugs | Uweport gloves met<br>requirements for testing<br>drugs listed in standard;<br>results of predicate not<br>known |

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## 510(k) Summary-Continued

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### 510(k) Summary-Continued

### SUMMARY of Non-Clinical TESTING:

| TESTING FOR | STANDARD/METHOD | ACCEPTANCE<br>CRITERIA | RESULTS |
|----------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Specifications | ASTM D6319-19 Standard Specification<br>for Nitrile Examination Gloves for<br>Medical Application | Per Standard- AQL =<br>2.5 and various | See comparative<br>chart above for<br>individual results |
| Holes in glove | ASTM D5151-2006 Standard Test Method<br>for Detection of Holes in Medical Gloves | AQL = 2.5, 125<br>samples from batch of<br>35000, inspection level<br>1, criterion ≤7 Zero<br>nonconforming | Zero<br>nonconforming |
| Resistance to<br>chemotherapy<br>drugs | ASTM D6978-05(2019) Assessment of<br>Resistance of Medical Gloves to<br>Permeation by Chemotherapy Drugs | Per standard | See indication for<br>use for details |
| Residual powder | ASTM D6124 Standard Test Method for<br>Residual Powder On Medical Gloves | residual powder 0.15;<br>0.18 and 0.19<br>mg/glove; | test results<br>acceptable |
| Biocompatibility | FDA Guidance document "Use of ISO<br>10993-1 issued June 16, 2016" and Part 5,<br>Part 10: | According to<br>biological reactivity to<br>L929 cells; According<br>to patch test reaction;<br>According to irritation<br>index | Passed all testing;<br>see comparative<br>chart for details |

### CLINICAL TESTING not required

CONCLUSION: The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, and as effective, and performs as well as or better than the legally marketed device identified.