(112 days)
Not Found
No
The device is a physical glove and the description focuses on its material properties and testing against chemotherapy drugs, with no mention of AI or ML.
No.
The device, Uweport Powder-Free Nitrile Examination Gloves, is described as preventing contamination between patient and examiner and is for medical purposes. It does not actively treat or alleviate a disease or condition, which is the definition of a therapeutic device.
No
Explanation: The device is an examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device is a physical glove made of nitrile, not a software program.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- Device Description: The description clearly states that these are examination gloves worn on the examiner's hand to prevent contamination between patient and examiner. They are a barrier device used on the body (the examiner's hand) during a medical procedure.
- Intended Use: The intended use is for medical purposes as a barrier, not for analyzing biological specimens.
- Testing: The testing mentioned (ASTM standards for physical properties and resistance to chemotherapy drugs) is relevant to the glove's function as a barrier, not to diagnostic testing of biological samples.
Therefore, based on the provided information, the Uweport Powder-Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs are a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner / Medical purposes
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical testing was performed including:
- Specifications: ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application; Acceptance Criteria: Per Standard- AQL = 2.5 and various; Results: See comparative chart above for individual results
- Holes in glove: ASTM D5151-2006 Standard Test Method for Detection of Holes in Medical Gloves; Acceptance Criteria: AQL = 2.5, 125 samples from batch of 35000, inspection level 1, criterion
§ 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.
0
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.
1
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
2
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
Detection Time in
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 |
| Charlotte, NC 28211 | |
| Contact | Mike Wang, President |
| Telephone: | 314 435-0587 |
| Email: | mwang@uweport.com |
| 510(k) CONTACT: | Elaine Duncan, M.S.M.E., RAC |
| President, Paladin Medical, Inc. | |
| PO Box 560 | |
| Stillwater, MN 55082 | |
| Telephone: | 715-549-6035 |
| DATE PREPARED: | January 14, 2022 |
| PRODUCT NAME: | Uweport Powder-Free Nitrile Examination Gloves |
| Tested for Use with Chemotherapy Drugs | |
| COMMON NAME: | Examination Glove |
| CLASSIFICATION NAME | Medical Gloves with Chemotherapy Labeling Claims |
| 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 |
| Examination Glove, Blue (Tested for Use with | |
| 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
Detection Time
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 |
4
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 | ||
| Free Nitrile Examination | |||
| Glove, Blue(Tested for | |||
| Use with Chemotherapy | |||
| Drugs) | Uweport Nitrile Exam Glove | ||
| (tested for use with | |||
| Chemotherapy Drugs) | |||
| 510(k) Reference | K210944 | K213227 | |
| Product Code | LZA, LZC, OPJ | LZA, LZC, OPJ | Same |
| Indication for Use | |||
| (partial) | The Harbour Health | ||
| Powder Free Nitrile | |||
| Examination Glove, Blue | |||
| (Tested for Use with | |||
| Chemotherapy Drugs) is a | |||
| disposable device intended | |||
| for medical purposes that is | |||
| worn on the examiner's | |||
| hand to prevent | |||
| contamination between | |||
| patient and examiner. The | |||
| proposed device was tested | |||
| for use with chemotherapy | |||
| drugs per ASTM D6978- | |||
| 05(2019), Standard Practice | |||
| for Assessment of Medical | |||
| Gloves to Permeation by | |||
| Chemotherapy Drugs | Uweport Powder-Free Nitrile | ||
| Exam Gloves Tested for Use | |||
| with Chemotherapy Drugs is a | |||
| non-sterile, 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. | Same | ||
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Design Features | Ambidextrous Textured | ||
| fingertipsBeaded cuff | |||
| Straight fingers | Ambidextrous | ||
| Textured fingertips | |||
| Beaded cuff Straight fingers | Similar | ||
| Sizes | Small, Medium, | ||
| Large, ExtraLarge | Small, Medium,Large, | ||
| Extra Large | Same | ||
| Dimension | |||
| Thickness | Complies with ASTM | ||
| D6319-19 | |||
| Palm: 0.05mm min. | |||
| Finger: 0.05mm min. | Complies with ASTM | ||
| D6319-19 | |||
| Palm: 0.07S; 0.08M; | |||
| 0.08L, 0.08mmXL all | |||
| ±0.03mm | |||
| Finger: 0.09 ± 0.03mm | Similar | ||
| Dimensions-Width | Complies with ASTM | ||
| D6319-19 | Complies with ASTM | ||
| D6319-19 | Similar | ||
| Characteristic | Predicate Device | UWEPORT | ComparisonAnalysis |
| Medium:95± 10mm | |||
| Large:110± 10mm | |||
| Extra Large:120 ±10mm | Medium:96± 5mm | ||
| Large:108± 5mm | |||
| Extra large:115±5mm | |||
| Dimensions Length | Complies with ASTM D6319-19 | ||
| Small: 220mm min. | |||
| Medium/Large/Extra Large: | |||
| 230mm- min | Complies with ASTM D6319-19 | ||
| Small: ≥220mm. | |||
| Medium/Large/Extra | |||
| Large: ≥240mm | |||
| Rx vs OTC | OTC | OTC | Same |
| Sterile vs | |||
| Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Disposable vs | |||
| Non-Disposable | Disposable | Disposable | Same |
| Biocompatibility | Complies with | ||
| ANSI/AAMI/ISO | |||
| 10993-5 (2009) |
- Under the conditions of the
study, the device is potentially
cytotoxic.
Complies with
ANSI/AAMI/ISO
10993-10 (2010) - Under the conditions of the
study, the device is a nonirritant
and a non-sensitizer.
Complies with
ANSI/AAMI/ISO
10993-11 (2017) - Under the conditions of the
study, the device does not elicit
a systemic toxicity response in
the model animal. | Cytotoxicity ISO 10993-5: At
100% extraction the cell viability
was 17.1%.
Sensitization ISO 10993-10 The
test article passed both extract
assays with a 0 score.
Irritation
ISO 10093-10
The test article from both extracts
was categorized as negligible under
the test conditions.
Acute Systemic Toxicity; ISO
10993-11:2017;
Under the conditions of the study
the test article extract met the
requirements of the study; Body
weight data and animal
appearance was normal
throughout the study. | Similar |
| Single Use vs
Reusable | Single Use | Single Use | Same |
| Physical
Properties
Tensile Strength | Complies with ASTM D6319-
19 Before Aging: >14 MPa
min. After Aging: >14 MPa,
min. | Complies with ASTM
D6319-19 at nominal
conditions ≥14 Mpa | Similar |
| Physical Properties
Elongation- | Complies with ASTM
D6319-19
Before Aging: 500% min.
After Aging:400% min. | Complies with ASTM
D6319-19 at nominal
conditions; ≥500 | similar |
| Freedom from
Holes | Complies with ASTM
D5151-19 and ASTM
D5151-19 G-1, AQL 2.5 | Complies with ASTM D5151-
19; AQL = 2.5, 125 samples
from batch of 35000,
inspection level 1, criterion ≤7
Zero nonconforming | Similar |
| Residual Powder | Complies with ASTM D6319-19