(112 days)
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.
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.
The provided document pertains to the 510(k) premarket notification for Uweport Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs. This is a submission for a Class I medical device (examination gloves) and as such, the performance criteria and data provided are related to the physical and chemical properties of the gloves, particularly their resistance to permeation by chemotherapy drugs, and not to an AI/ML-based diagnostic or prognostic device.
Therefore, many of the requested categories (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, AI/ML training set information) are not applicable to this type of medical device submission.
However, I can extract the relevant information regarding acceptance criteria and study results for this specific device type:
Acceptance Criteria and Device Performance for Uweport Powder-Free Nitrile Examination Gloves
This summary addresses the performance of Uweport Powder-Free Nitrile Examination Gloves, focusing on their resistance to chemotherapy drug permeation as per the FDA 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The primary performance criterion for these gloves, beyond general examination glove standards, is their resistance to permeation by chemotherapy drugs. This was assessed according to ASTM D6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The acceptance criteria are "Per standard," implying that the breakthrough detection times must meet or exceed a specific threshold or be reported as determined by the standard.
| Drug Tested | Concentration | Acceptance Criteria (Breakthrough Detection Time in Minutes) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | Per ASTM D6978-05(2019) Standard* | 22.8 |
| Cisplatin | 1 mg/ml (1,000 ppm) | Per ASTM D6978-05(2019) Standard* | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | Per ASTM D6978-05(2019) Standard* | >240 |
| Dacarbazine | 10 mg/ml (10,000 ppm) | Per ASTM D6978-05(2019) Standard* | >240 |
| Doxorubicin | 2 mg/ml (2,000 ppm) | Per ASTM D6978-05(2019) Standard* | >240 |
| Etoposide | 20 mg/ml (20,000 ppm) | Per ASTM D6978-05(2019) Standard* | >240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | Per ASTM D6978-05(2019) Standard* | >240 |
| Paclitaxel | 6 mg/ml (6,000 ppm) | Per ASTM D6978-05(2019) Standard* | >240 |
| ThioTepa | 10.0 mg/ml (10,000 ppm) | Per ASTM D6978-05(2019) Standard* | 46.8 |
* The "Per standard" acceptance criteria imply that the results obtained are consistent with the methodology and reporting requirements of the ASTM D6978-05(2019) standard, validating the glove's performance for labeled use, even if the permeation time is relatively short for certain drugs. The warning explicitly states that the gloves are "Not recommended for use with Carmustine and Thiotepa" due to their low permeation times.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size (number of gloves) used for the chemotherapy drug permeation testing. However, the testing was conducted according to ASTM D6978-05(2019), which specifies sample preparation and testing methods. For general glove properties like "Freedom from Holes," the sample size is specified as 125 samples from a batch of 35,000, with an inspection level 1 and a criterion of ≤7 non-conforming items for AQL = 2.5.
Data Provenance: The tests appear to be laboratory-based performance tests, likely conducted in a controlled environment to meet the ASTM standard. The country of origin of the data is not specified, but it's generated for an FDA 510(k) submission in the United States. The data is prospective in the sense that the tests were performed specifically to evaluate the device's performance for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a performance specification test for a physical medical device (gloves), not an AI/ML diagnostic device requiring expert interpretation or ground truth establishment in the clinical sense. The "ground truth" for permeation is determined by laboratory measurement according to the specified ASTM standard.
4. Adjudication Method for the Test Set
Not applicable. This is a laboratory performance test, not a clinical study involving human interpretation or adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an examination glove, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the chemotherapy drug permeation test is established by objective, quantitative laboratory measurements of breakthrough detection time according to the ASTM D6978-05(2019) standard.
For other properties, the ground truth is also established by specific ASTM standards:
- Physical Properties (Tensile Strength, Elongation): ASTM D6319-19
- Freedom from Holes: ASTM D5151-19
- Residual Powder: ASTM D6124
- Biocompatibility: ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization, Irritation), ISO 10993-11 (Acute Systemic Toxicity).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/ML device. The manufacturing processes and material formulations are based on established engineering and materials science principles for glove production, rather than data-driven learning.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no "training set" as this is not an AI/ML device.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 | BreakthroughDetection Time inMinutes |
|---|---|---|
| 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 201Charlotte, NC 28211 |
| Contact | Mike Wang, President |
| Telephone: | 314 435-0587 |
| Email: | mwang@uweport.com |
| 510(k) CONTACT: | Elaine Duncan, M.S.M.E., RACPresident, Paladin Medical, Inc.PO Box 560Stillwater, MN 55082 |
| Telephone: | 715-549-6035 |
| DATE PREPARED: | January 14, 2022 |
| PRODUCT NAME: | Uweport Powder-Free Nitrile Examination GlovesTested for Use with Chemotherapy Drugs |
| COMMON NAME: | Examination Glove |
| CLASSIFICATION NAME | Medical Gloves with Chemotherapy Labeling ClaimsTest 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 NitrileExamination Glove, Blue (Tested for Use withChemotherapy 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 | BreakthroughDetection TimeMinutes |
|---|---|---|
| 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 PowderFree Nitrile ExaminationGlove, Blue(Tested forUse with ChemotherapyDrugs) | Uweport Nitrile Exam Glove(tested for use withChemotherapy Drugs) | |
| 510(k) Reference | K210944 | K213227 | |
| Product Code | LZA, LZC, OPJ | LZA, LZC, OPJ | Same |
| Indication for Use(partial) | The Harbour HealthPowder Free NitrileExamination Glove, Blue(Tested for Use withChemotherapy Drugs) is adisposable device intendedfor medical purposes that isworn on the examiner'shand to preventcontamination betweenpatient and examiner. Theproposed device was testedfor use with chemotherapydrugs per ASTM D6978-05(2019), Standard Practicefor Assessment of MedicalGloves to Permeation byChemotherapy Drugs | Uweport Powder-Free NitrileExam Gloves Tested for Usewith Chemotherapy Drugs is anon-sterile, disposable deviceintended for medical purposesthat is worn on the examiner'shand to prevent contaminationbetween patient and examiner.These Gloves have been testedfor use with chemotherapy drugsper ASTM D6978-05(2019)Standard Practice forAssessment of Resistance ofMedical Gloves to Permeationby 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 TexturedfingertipsBeaded cuffStraight fingers | AmbidextrousTextured fingertipsBeaded cuff Straight fingers | Similar |
| Sizes | Small, Medium,Large, ExtraLarge | Small, Medium,Large,Extra Large | Same |
| DimensionThickness | Complies with ASTMD6319-19Palm: 0.05mm min.Finger: 0.05mm min. | Complies with ASTMD6319-19Palm: 0.07S; 0.08M;0.08L, 0.08mmXL all±0.03mmFinger: 0.09 ± 0.03mm | Similar |
| Dimensions-Width | Complies with ASTMD6319-19 | Complies with ASTMD6319-19 | Similar |
| Characteristic | Predicate Device | UWEPORT | ComparisonAnalysis |
| Medium:95± 10mmLarge:110± 10mmExtra Large:120 ±10mm | Medium:96± 5mmLarge:108± 5mmExtra large:115±5mm | ||
| Dimensions Length | Complies with ASTM D6319-19Small: 220mm min.Medium/Large/Extra Large:230mm- min | Complies with ASTM D6319-19Small: ≥220mm.Medium/Large/ExtraLarge: ≥240mm | |
| Rx vs OTC | OTC | OTC | Same |
| Sterile vsNon-Sterile | Non-Sterile | Non-Sterile | Same |
| Disposable vsNon-Disposable | Disposable | Disposable | Same |
| Biocompatibility | Complies withANSI/AAMI/ISO10993-5 (2009)* Under the conditions of thestudy, the device is potentiallycytotoxic.Complies withANSI/AAMI/ISO10993-10 (2010)* Under the conditions of thestudy, the device is a nonirritantand a non-sensitizer.Complies withANSI/AAMI/ISO10993-11 (2017)* Under the conditions of thestudy, the device does not elicita systemic toxicity response inthe model animal. | Cytotoxicity ISO 10993-5: At100% extraction the cell viabilitywas 17.1%.Sensitization ISO 10993-10 Thetest article passed both extractassays with a 0 score.IrritationISO 10093-10The test article from both extractswas categorized as negligible underthe test conditions.Acute Systemic Toxicity; ISO10993-11:2017;Under the conditions of the studythe test article extract met therequirements of the study; Bodyweight data and animalappearance was normalthroughout the study. | Similar |
| Single Use vsReusable | Single Use | Single Use | Same |
| PhysicalPropertiesTensile Strength | Complies with ASTM D6319-19 Before Aging: >14 MPamin. After Aging: >14 MPa,min. | Complies with ASTMD6319-19 at nominalconditions ≥14 Mpa | Similar |
| Physical PropertiesElongation- | Complies with ASTMD6319-19Before Aging: 500% min.After Aging:400% min. | Complies with ASTMD6319-19 at nominalconditions; ≥500 | similar |
| Freedom fromHoles | Complies with ASTMD5151-19 and ASTMD5151-19 G-1, AQL 2.5 | Complies with ASTM D5151-19; AQL = 2.5, 125 samplesfrom batch of 35000,inspection level 1, criterion ≤7Zero nonconforming | Similar |
| Residual Powder | Complies with ASTM D6319-19< 2 mg per glove | ASTM D6124 Standard TestMethod for Residual Powder OnMedical Gloves; residual powder0.15; 0.18 and 0.19 mg/glove; | Similar |
| Characteristic | Predicate Device | UWEPORT | ComparisonAnalysis |
| ChemotherapyPermeation | ASTM D6978-05(2019)Assessment of Resistance ofMedical Gloves toPermeation byChemotherapy Drugs | ASTM D6978-05(2019)Assessment of Resistance ofMedical Gloves to Permeationby Chemotherapy Drugs | Uweport gloves metrequirements for testingdrugs listed in standard;results of predicate notknown |
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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 | ACCEPTANCECRITERIA | RESULTS |
|---|---|---|---|
| Specifications | ASTM D6319-19 Standard Specificationfor Nitrile Examination Gloves forMedical Application | Per Standard- AQL =2.5 and various | See comparativechart above forindividual results |
| Holes in glove | ASTM D5151-2006 Standard Test Methodfor Detection of Holes in Medical Gloves | AQL = 2.5, 125samples from batch of35000, inspection level1, criterion ≤7 Zerononconforming | Zerononconforming |
| Resistance tochemotherapydrugs | ASTM D6978-05(2019) Assessment ofResistance of Medical Gloves toPermeation by Chemotherapy Drugs | Per standard | See indication foruse for details |
| Residual powder | ASTM D6124 Standard Test Method forResidual Powder On Medical Gloves | residual powder 0.15;0.18 and 0.19mg/glove; | test resultsacceptable |
| Biocompatibility | FDA Guidance document "Use of ISO10993-1 issued June 16, 2016" and Part 5,Part 10: | According tobiological reactivity toL929 cells; Accordingto patch test reaction;According to irritationindex | Passed all testing;see comparativechart 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.
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.