(217 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of examination gloves, with no mention of AI or ML technology.
No
The device is described as an examination glove intended to prevent contamination between a patient and an examiner. It does not treat or cure any medical condition.
No
The device described is an examination glove, which is a barrier device intended to prevent contamination between a patient and an examiner. It does not perform any diagnostic function.
No
The device is a physical examination glove, which is a hardware medical device, not software. The summary describes physical testing and material properties.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device for personal protection and infection control.
- Device Description: The description reinforces this by stating the gloves are "intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner."
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such analysis or provide diagnostic information.
- Testing: The testing described focuses on the physical properties of the glove (dimensions, freedom from holes, powder content) and its barrier properties against chemotherapy drugs and Fentanyl. This is consistent with testing for a protective barrier device, not an IVD.
The testing for chemotherapy drugs and Fentanyl is related to the glove's ability to protect the user from these substances, which is a safety and barrier function, not an in vitro diagnostic function.
N/A
Intended Use / 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 and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves of Permeation by Chemotherapy Drugs
Product codes
LZA, OPJ, QDO
Device Description
The Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) – Regular Cuff and the Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentany)) - Extended Cuff 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 nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The proposed device is offered in two versions: Regular cuff (VS311) and Extended cuff (VS711).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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)
Biocompatibility Testing
Study Type: Testing for Irritation and Skin Sensitization (ISO 10993-10: 2010), Cytotoxicity (ISO 10993-5:2009), Systemic Toxicity (ISO 10993-11: 2017)
Sample Size: Not specified for each test, but performed on the Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) – Regular Cuff and the Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff.
Key Results:
- Irritation Testing: Pass. Under the conditions of the study, the subject device is not a primary skin irritant.
- Sensitization Testing: Pass. Under the conditions of the study, the subject device is not a primary skin sensitizer.
- Cytotoxicity Testing: Failed. Under the conditions of the study, the subject device is cytotoxic.
- Systemic Toxicity Testing: Pass. Under the conditions of the study, the subject device is not toxic.
Physical Dimensions Testing
Study Type: Conformance to ASTM D6319-10
Sample Size: Thirteen (13) glove samples of each size (extra-small, small, medium, large and extra-large).
Key Results: All samples from each of the five size gloves met the specifications for physical dimensions.
Freedom from Holes Testing
Study Type: Conformance to ASTM D5151-06 and FDA 1000ml Water Leak Test
Key Results: The gloves passed the freedom from holes test for all sizes.
Powder Content Testing
Study Type: Conformance to ASTM D6124-06
Key Results: The average residual powder content for all sizes (XS/S/M/L/XL) was less than 2mg/glove, meeting the specification.
Permeation Testing
Study Type: Conformance to ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Key Results: Minimum breakthrough times were determined for a wide range of chemotherapy drugs and Fentanyl. Carmustine and Thiotepa showed low permeation times, which will be included in labeling with a caution statement. Most drugs showed a breakthrough time of >240 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 4, 2020
Leontyne Banks Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K193666
Trade/Device Name: Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) - Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentany)) -Extended Cuff Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, OPJ Dated: June 10, 2020 Received: June 10, 2020
Dear Leontyne Banks:
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 (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
CAPT 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
2
Indications for Use
510(k) Number (if known)
K193666
Device Name
Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) – Regular Cuff
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.
| Chemo Drugs Tested: | Breakthrough Time (Minutes) |
|---|---|
| Aresenic Trioxide 1 mg/ml (1,000 ppm) | >240 |
| Azacitidine 25 mg/ml (25,000 ppm) | >240 |
| Bendamustine 5 mg/ml (5,000 ppm) | >240 |
| Bleomycin 15 mg/ml (15,000 ppm) | >240 |
| Bortezomib 1 mg/ml (1,000 ppm) | >240 |
| Busulfan 6 mg/ml (6,000 ppm) | >240 |
| Carboplatin 10.0 mg/ml (10,000 ppm) | >240 |
| Carfilzomib 2.0 mg/ml (2,000) | >240 |
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 33.1 min |
| Cetuximab 2.0 mg/ml (2,000) | >240 |
| Cisplatin 1.0 mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml (20,000 ppm) | >240 |
| Cytarabine 100 mg/ml (100,000 ppm) | >240 |
| Cytovene 10 mg/ml (10,000 ppm) | >240 |
| Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) | >240 |
| Daunorubicin 5 mg/ml (5,000 ppm) | >240 |
| Decitabine 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel 10.0 mg/ml (10,000 ppm) | >240 |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | >240 |
| Epirubicin (Ellence) 2.0 mg/ml (2,000 ppm) | >240 |
| Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) | >240 |
| Fludarabine 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil 50.0 mg/ml (50,000 ppm) | >240 |
| Fulvestrant 50.0 mg/ml (50,000 ppm) | >240 |
| Gemcitabine (Gemzar) 38 mg/ml (38,000 ppm) | >240 |
| Idarubicin 1 mg/ml (1,000 ppm) | >240 |
| Ifosfamide 50.0 mg/ml (50,000 ppm) | >240 |
| Irinotecan 20.0 mg/ml (20,000 ppm) | >240 |
| Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) | >240 |
| Melphalan 5 mg/ml (5,000 ppm) | >240 |
| Methotrexate 25 mg/ml (25,000 ppm) | >240 |
| Mitomycin C 0.5 mg/ml (500 ppm) | >240 |
| Mitoxantrone 2.0 mg/ml (2,000 ppm) | >240 |
| Oxaliplatin 2.0 mg/ml (2,000 ppm) | >240 |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | >240 |
| Paraplatin 10 mg/ml (10,000 ppm) | >240 |
| Pemetrexed Disodium 25.0 mg/ml (25,000 ppm) | >240 |
| Pertuzumab 30 mg/ml (30,000 ppm) | >240 |
| Raltitrexed 0.5 mg/ml (500 ppm) | >240 |
| Retrovir 10.0 mg/ml (10,000 ppm) | >240 |
| Rituximab 10 mg/ml (10,000 ppm) | >240 |
| Temsirolimus 25.0 mg/ml (25,000 ppm) | >240 |
| Thiotepa 10.0 mg/ml (10,000 ppm) | 69.2 min |
| Topotecan HCI 1.0 mg/ml (1,000 ppm) | >240 |
| Trastuzumab 21.0 mg/ml (21,000 ppm) | >240 |
| Trisonex 1 mg/ml (1,000 ppm) | >240 |
| Vinblastine 1 mg/ml (1,000 ppm) | >240 |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | >240 |
| Vinorelbine 10 mg/ml (10,000 ppm) | >240 |
| Zoledronic Acid 0.8 mg/ml (800 ppm) | >240 |
| Fentanyl Citrate, 100mcg/2mL | >240 |
| Chemotherapy Drug Tested | Breakthrough Time (in minutes) |
| Aresenic Trioxide 1 mg/ml | >240 |
| Azacitidine 25 mg/ml | >240 |
| Bendamustine 5 mg/ml | >240 |
| Bleomycin 15 mg/m | >240 |
| Bortezomib 1 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carfilzomib 2 mg/ml | >240 |
| Carmustine (BCNU) 3.3 mg/ml | 59.4 min |
| Cetuximab | >240 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml | >240 |
| Cytarabine Hydrochloride 100 mg/ml | >240 |
| Cytovene 10 mg/ml | >240 |
| Dacarbazine (DTIC) 10.0 mg/ml | >240 |
| Daunorubicin 5 mg/ml | >240 |
| Decitabine 5 mg/ml | >240 |
| Docetaxel 10.0 mg/ml | >240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | >240 |
| Epirubicin (Ellence) 2.0 mg/ml | >240 |
| Etoposide (Toposar) 20.0 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50.0 mg/ml | >240 |
| Fulvestrant 50.0 mg/ml | >240 |
| Gemcitabine (Gemzar) 38 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Ifosfamide 50.0 mg/ml | >240 |
| Irinotecan 20.0 mg/ml | >240 |
| Mechlorethamine HCI 1.0 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25.0 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 |
| Mitoxantrone 2mg/ml | >240 |
| Oxaliplatin 5.0 mg/ml | >240 |
| Paclitaxel (Taxol) 6.0 mg/ml | >240 |
| Paraplatin (Carboplatin) 10 mg/ml | >240 |
| Pemetrexed Disodium 25.0 mg/ml | >240 |
| Pertuzumab 30 mg/ml | >240 |
| Raltitrexed 0.5 mg/ml | >240 |
| Retrovir 10.0 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Temsirolimus 25.0 mg/ml | >240 |
| Thiotepa 10.0 mg/ml | 68.2 min |
| Topotecan HCI 1.0 mg/ml | >240 |
| Trastuzumab 21.0 mg/ml | >240 |
| Trisonex 1 mg/ml | >240 |
| Vinblastine 1 mg/ml | >240 |
| Vincristine Sulfate 1.0 mg/ml | >240 |
| Vinorelbine 10 mg/ml | >240 |
| Zoledronic Acid 0.8 mg/ml | >240 |
| Fentanyl Citrate, 100mcg/2mL | >240 |
3
Please note that the following drug has low permeation time:
Carmustine (BCNU) (3.3 mg/ml) 33.1 minutes
Thiotepa (THT) (10.0mg/ml) 69.2 minutes
CAUTION: Testing showed an average breakthrough time of 33.1 minutes with Carmustine and 69.2 minutes with 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K193666
Device Name
Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff
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.
5
Please note that the following drug has low permeation time:
Carmustine (BCNU) (3.3 mg/ml) 59.4 minutes
Thiotepa (THT) (10.0 mg/ml) 68.2 minutes
CAUTION: Testing showed an average breakthrough time of 59.4 minutes with Carmustine and 68.2 minutes with 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
6
Image /page/6/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. A white, stylized cross is prominently displayed, with the word "MEDLINE" in white, bold letters superimposed over the center of the cross. A small gray rectangle is visible in the upper right corner of the image.
hree Lakes Drive Northfield. IL 60093
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 Applicant Contact: Leontyne Banks Regulatory Affairs Specialist
Summary Preparation Date
July 31, 2020
Type of 510(k) Submission
Traditional
Device Name / Classification
Name of Device: Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff
Proprietary Name: Medline Powder-Free Blue Nitrile Patient Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Regular Cuff; Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff Common Name: Patient Examination Glove, Specialty
Classification Name: Polymer Patient Exam Glove, Medical Gloves with Chemotherapy/Fentanyl Labeling Claims
Product Code: LZA, OPJ, QDO Classification Panel: General Hospital Regulation #: 21 CFR 880.6250
Predicate Device
YTY Industry (Manjung): Non-Sterile, Powder-Free Nitrile Examination Gloves (Cobalt Blue) Tested for use with Chemotherapy Drugs - K111248
7
Image /page/7/Picture/0 description: The image is a logo for Medline. The logo is set against a blue background. The word "MEDLINE" is in white, bold, sans-serif font. A white star-like symbol is behind the word "MEDLINE".
Medline Industries, Inc.
Three Lakes Drive
Northfield, IL 60093
Device Description
The Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) – Regular Cuff and the Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentany)) - Extended Cuff 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 nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The proposed device is offered in two versions: Regular cuff (VS311) and Extended cuff (VS711).
| Model Number | Size |
|---|---|
| VS311XS | Extra-Small |
| VS311S | Small |
| VS311M | Medium |
| VS311L | Large |
| VS311XL | Extra-Large |
TABLE 1: The Medline Powder-Free Blue Nitrile Examination Gloves – Regular Cuff Sizes
TABLE 2: The Medline Powder-Free Blue Nitrile Examination Gloves – Extended Cuff Sizes
| Model Number | Size |
|---|---|
| VS711XS | Extra-Small |
| VS711S | Small |
| VS711M | Medium |
| VS711L | Large |
| VS711XL | Extra-Large |
The gloves are designed and manufactured in accordance with the ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application and are tested for use with chemotherapy drugs as well as for use with Fentanyl per ASTM D6978-05 (Reapproved 2019).
Indications for Use - Regular Cuff (VS311XS, VS311S, VS311M, VS311L and VS311XL)
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
8
Image /page/8/Picture/0 description: The image is a square logo for Medline. The logo is set against a blue background. The word "MEDLINE" is written in white, block letters, and a white star-like symbol is above and below the word. The star symbol has four points, with the top and bottom points being longer than the side points.
for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs
| Chemo Drugs Tested: | Breakthrough Time (Minutes) |
|---|---|
| Aresenic Trioxide 1 mg/ml (1,000 ppm) | >240 |
| Azacitidine 25 mg/ml (25,000 ppm) | >240 |
| Bendamustine 5 mg/ml (5,000 ppm) | >240 |
| Bleomycin 15 mg/ml (15,000 ppm) | >240 |
| Bortezomib 1 mg/ml (1,000 ppm) | >240 |
| Busulfan 6 mg/ml (6,000 ppm) | >240 |
| Carboplatin 10.0 mg/ml (10,000 ppm) | >240 |
| Carfilzomib 2.0 mg/ml (2,000) | >240 |
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 33.1 min |
| Cetuximab 2.0 mg/ml (2,000) | >240 |
| Cisplatin 1.0 mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml (20,000 ppm) | >240 |
| Cytarabine 100 mg/ml (100,000 ppm) | >240 |
| Cytovene 10 mg/ml (10,000 ppm) | >240 |
| Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) | >240 |
| Daunorubicin 5 mg/ml (5,000 ppm) | >240 |
| Decitabine 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel 10.0 mg/ml (10,000 ppm) | >240 |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | >240 |
| Epirubicin (Ellence) 2.0 mg/ml (2,000 ppm) | >240 |
| Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) | >240 |
| Fludarabine 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil 50.0 mg/ml (50,000 ppm) | >240 |
| Fulvestrant 50.0 mg/ml (50,000 ppm) | >240 |
| Gemcitabine (Gemzar) 38 mg/ml (38,000 ppm) | >240 |
| Idarubicin 1 mg/ml (1,000 ppm) | >240 |
| Ifosfamide 50.0 mg/ml (50,000 ppm) | >240 |
| Irinotecan 20.0 mg/ml (20,000 ppm) | >240 |
| Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) | >240 |
| Melphalan 5 mg/ml (5,000 ppm) | >240 |
| Methotrexate 25 mg/ml (25,000 ppm) | >240 |
| Mitomycin C 0.5 mg/ml (500 ppm) | >240 |
| Mitoxantrone 2.0 mg/ml (2,000 ppm) | >240 |
| Oxaliplatin 2.0 mg/ml (2,000 ppm) | >240 |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | >240 |
| Paraplatin 10 mg/ml (10,000 ppm) | >240 |
| Pemetrexed Disodium 25.0 mg/ml (25,000 ppm) | >240 |
| Pertuzumab 30 mg/ml (30,000 ppm) | >240 |
| Raltitrexed 0.5 mg/ml (500 ppm) | >240 |
| Retrovir 10.0 mg/ml (10,000 ppm) | >240 |
| Rituximab 10 mg/ml (10,000 ppm) | >240 |
| Temsirolimus 25.0 mg/ml (25,000 ppm) | >240 |
| Thiotepa 10.0 mg/ml (10,000 ppm) | 69.2 min |
| Topotecan HCI 1.0 mg/ml (1,000 ppm) | >240 |
| Trastuzumab 21.0 mg/ml (21,000 ppm) | >240 |
| Trisonex 1 mg/ml (1,000 ppm) | >240 |
| Vinblastine 1 mg/ml (1,000 ppm) | >240 |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | >240 |
| Vinorelbine 10 mg/ml (10,000 ppm) | >240 |
| Zoledronic Acid 0.8 mg/ml (800 ppm) | >240 |
| Fentanyl Citrate, 100mcg/2mL | >240 |
9
Image /page/9/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, with a stylized white cross behind it. The background is a solid dark blue. There is a gray bar on the right side of the image.
Northfield II 60093
Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 33.1 minutes Thiotepa (10.0 mg/ml) 69.2 minutes
CAUTION: Testing showed an average breakthrough time of 33.1 minutes with Carmustine and 69.2 minutes with Thiotepa.
Indications for Use – Extended Cuff (VS711XS, VS711M, VS711M, VS711L and VS711XL)
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 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemo Drugs Tested: | Breakthrough Time (Minutes |
|---|---|
| Aresenic Trioxide 1 mg/ml | >240 |
| Azacitidine 25 mg/ml | >240 |
| Bendamustine 5 mg/ml | >240 |
| Bleomycin 15 mg/m | >240 |
| Bortezomib 1 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carfilzomib 2 mg/ml | >240 |
| Carmustine (BCNU) 3.3 mg/ml | 59.4 min |
| Cetuximab | >240 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml | >240 |
| Cytarabine Hydrochloride 100 mg/ml | >240 |
| Cytovene 10 mg/ml | >240 |
| Dacarbazine (DTIC) 10.0 mg/ml | >240 |
| Daunorubicin 5 mg/ml | >240 |
| Decitabine 5 mg/ml | >240 |
| Docetaxel 10.0 mg/ml | >240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | >240 |
| Epirubicin (Ellence) 2.0 mg/ml | >240 |
| Etoposide (Toposar) 20.0 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50.0 mg/ml | >240 |
| Fulvestrant 50.0 mg/ml | >240 |
| Gemcitabine (Gemzar) 38 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Irinotecan 20.0 mg/ml | >240 |
| Mechlorethamine HCI 1.0 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25.0 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 |
| Oxaliplatin 5.0 mg/ml | >240 |
| Paclitaxel (Taxol) 6.0 mg/ml | >240 |
| Paraplatin (Carboplatin) 10 mg/ml | >240 |
| Pemetrexed Disodium 25.0 mg/ml | >240 |
| Pertuzumab 30 mg/ml | >240 |
| Raltitrexed 0.5 mg/ml | >240 |
| Retrovir 10.0 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Temsirolimus 25.0 mg/ml | >240 |
| Thiotepa 10.0 mg/ml | 68.2 min |
| Topotecan HCI 1.0 mg/ml | >240 |
| Trastuzumab 21.0 mg/ml | >240 |
| Trisonex 1 mg/ml | >240 |
| Vinblastine 1 mg/ml | >240 |
| Vincristine Sulfate 1.0 mg/ml | >240 |
| Vinorelbine 10 mg/ml | >240 |
| Zoledronic Acid 0.8 mg/ml | >240 |
| Fentanyl Citrate, 100mcg/2mL | >240 |
10
Image /page/10/Picture/0 description: The image shows the Medline logo. The logo features the word "MEDLINE" in white, bold, sans-serif font, positioned to the left of a white, four-pointed star-like symbol. The background is a solid dark blue color. A small gray rectangle is visible in the upper right corner of the image.
11
Image /page/11/Picture/0 description: The image is a logo for Medline. The logo consists of the word "MEDLINE" in a sans-serif font, with a white cross-like symbol to the right of the text. The background is a solid blue color. There is a gray bar at the top right corner of the image.
Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 59.4 minutes Thiotepa (10.0 mg/ml) 68.2 minutes
CAUTION: Testing showed an average breakthrough time of 59.4 minutes with Carmustine and 68.2 minutes with Thiotepa.
Comparison of Technological Characteristics
| Device
Characteristic | Proposed
Device
VS311 | Predicate
Device | Comparison Analysis |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Product Name | Medline Powder-Free Blue
Nitrile Examination Gloves
(Tested for use with
Chemotherapy Drugs and
Fentanyl)
Regular Cuff | Non-Sterile, Powder-Free
Nitrile Examination Gloves
(Cobalt) Tested for use with
chemotherapy drugs | N/A |
| 510(k) Reference | K193666 | K111248 | N/A |
| Product Owner | Medline Industries, Inc. | YTY Industry (Manjung) SDN,
BHD | N/A |
| Product Code | LZA, OPJ, QDO | LZA, LZC | Similar |
| | | | |
| 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
and Fentanyl Citrate as per
ASTM D6978-05 (Reapproved
2019) Standard Practice for
Assessment of Medical Gloves
of Permeation by
Chemotherapy Drugs | A patient examination glove is
a disposable device intended
for medical purposes that is
worn on the examiner's hand
or fingers to prevent
contamination between
patient and examiner.
These glove were tested for
use with chemotherapy drugs. | Same |
| Regulation
Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Materials | Powder-Free Nitrile | Powder-Free Nitrile | Same |
| Color | Blue | Blue | Same |
| Sizes | x- small, small, medium, large,
x-large | Medium, Large, Extra-large | Similar |
| Dimensions -
Length | Complies with:
ASTM D6319-10
220mm min. | Complies with:
ASTM D6319-10
220mm min. | Same |
| Dimensions -
Width | Complies with:
ASTM D6319-10
70mm min | Complies with:
ASTM D6319-10
70mm min | Same |
| Dimensions -
Thickness | Complies with:
ASTM D6319-10
Palm – 0.05mm min.
Finger – 0.05mm min. | Complies with:
ASTM D6319-10
Palm – 0.05mm min.
Finger – 0.05mm min. | Same |
| Physical
Properties | Complies with:
ASTM D6319-10 minimum:
Tensile Strength:
Before Aging ≥14 MPa, min.
After Aging ≥14 MPa, min.
Elongation:
Before Aging 500%, min.
After Aging 400%, min. | Complies with:
ASTM D6319-10 minimum:
Tensile Strength:
Before Aging ≥14 MPa, min.
After Aging ≥14 MPa, min.
Elongation:
Before Aging 500% min.
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 2.5 | Same |
| Powder or
Powder-Free | Powder-Free | Powder-Free | Same |
| Residual Powder | Complies with:
ASTM D6319-10
240 min. | | Different |
| | Azacitidine (Vidaza) 25.0 mg/ml
(25,000 ppm)
240 min. | | Different |
| | Bendamustine 5.0 mg/ml (5,000
ppm)
240 min. | | Different |
| | Bleomycin 15.0 mg/ml (15,000
ppm)
240 min. | | Different |
| | Bortezomib 1.0 mg/ml
(1,000 ppm) | | Different |
| | | | |
| Busulfan 6.0 mg/ml
(6,000 ppm)
240 min. | | Different | |
| Carboplatin 10mg/ml
10,000 ppm
240 min | Carboplatin 10mg/ml
10,000 ppm
240 min | Same | |
| Carfilzomib 2.0 mg/ml
(2,000 ppm)
240 min. | | Different | |
| Carmustine (BCNU) 3.3 mg/ml
(3,300 ppm)
33.1 min. | Carmustine (BCNU) 3.3 mg/ml
(3,300 ppm)
1.82 min | Similar | |
| Cetuximab 2.0 mg/ml
(2,000 ppm)
240 min | | Different | |
| Cisplatin 1.0 mg/ml
(1,000 ppm)
240 min. | Cisplatin 1.0 mg/ml
(1,000 ppm)
240 min. | Same | |
| Cyclophosphamide (Cytoxan)
20.0 mg/ml
(20,000 ppm)
240 min. | Cyclophosphamide (Cytoxan)
20.0 mg/ml
(20,000 ppm)
240 min. | Same | |
| Cytarabine 100.0 mg/ml
(100,000 ppm)
240 min. | | Different | |
| Cytovene 10.0 mg/ml
(10,000 ppm)
240 min. | | Different | |
| Dacarbazine (DTIC) 10.0 mg/ml
(10,000 ppm)
240 min. | Dacarbazine (DTIC) 10 mg/ml
(10,000 ppm)
240 min. | Same | |
| Daunorubicin 5.0 mg/ml
(5,000 ppm)
240 min. | | Different | |
| Decitabine 5.0 mg/ml
(5,000 ppm)
240 min. | | Different | |
| Docetaxel 10.0 mg/ml
(10,000 ppm)
240 min. | | Different | |
| Doxorubicin Hydrochloride 2.0
mg/ml
(2,000 ppm)
240 min. * | Doxorubicin Hydrochloride
2.0 mg/ml
(2,000 ppm)
240 min | Same | |
| Epirubicin (Ellence)
2.0 mg/ml
(2,000 ppm)
240 min. | | Different | |
| Etoposide (Toposar)
20.0 mg/ml
(20,000 ppm)
240 min. * | Etoposide (Toposar)
20.0 mg/ml
(20,000 ppm)
240 min. | Same | |
| Fludarabine 25.0 mg/ml
(25,000 ppm)
240 min. | | Different | |
| Fluorouracil 50.0 mg/ml
(50,000 ppm)
240 min. | Fluorouracil 50.0 mg/ml
(50,000 ppm)
240 min. | Same | |
| Fulvestrant 50.0 mg/ml (50,000 ppm)
240 min. | | Different | |
| Gemcitabine (Gemzar) 38.0
mg/ml
(38,000 ppm)
240 min. | | Different | |
| Idarubicin 1.0 mg/ml
(1,000 ppm)
240 min. | | Different | |
| Ifosfamide 50.0 mg/ml
(50,000 ppm)
240 min. | Ifosfamide 50.0 mg/ml
(50,000 ppm)
240 min. | Same | |
| Irinotecan 20.0 mg/ml
(20,000 ppm)
240 min. | | Different | |
| Mechlorethamine HCl 1.0
mg/ml
(1,000 ppm)
240 min. | | Different | |
| Melphalan 5.0 mg/ml
(5,000 ppm)
240 min. | | Different | |
| | | | |
| Methotrexate 25.0 mg/ml
(25,000 ppm)
240 min. * | Methotrexate 25.0 mg/ml
(25,000 ppm)
240 min. | Same | |
| Mitomycin C 0.5 mg/ml
(500 ppm)
240 min. | Mitomycin C 0.5 mg/ml
(2,000 ppm)
240 min. | Same | |
| Mitoxantrone 2.0 mg/ml
(2,000 ppm)
240 min. | Mitoxantrone 2.0 mg/ml
(2,000 ppm)
240 min. | Same | |
| Oxaliplatin 2.0 mg/ml
(2,000 ppm)
240 min. | | Different | |
| Paclitaxel (Taxol) 6.0 mg/ml
(6,000 ppm)
240 min. | Paclitaxel (Taxol) 6.0 mg/ml
(6,000 ppm)
240 min. | Same | |
| Paraplatin 10.0 mg/ml
(10,000 ppm)
240 min. | | Different | |
| Pemetrexed Disodium 25.0 mg/ml
(25,000 ppm)
240 min. | | Different | |
| Pertuzumab 30.0 mg/ml
(30,000 ppm)
240 min. | | Different | |
| Raltitrexed 0.5 mg/ml
(500 ppm)
240> min. | | Different | |
| Retrovir 10.0 mg/ml
(10,000 ppm)
240> min. | | Different | |
| Rituximab 10.0 mg/ml (10,000 ppm)
240> min. | | Different | |
| Temsirolimus 25.0 mg/ml
(25,000 ppm)
240> min. | | Different | |
| Thiotepa 10.0 mg/ml
(10,000 ppm)
69.2 min. | Thiotepa 10.0 mg/ml
(10,000 ppm)
0.93 min. | Similar | |
| | Topotecan HCI 1.0 mg/ml
(1,000 ppm)
240> min. | | Different |
| | Trastuzumab 21.0 mg/ml
(21,000 ppm)
240> min. | | Different |
| | Trisonex 1.0 mg/ml
(1,000 ppm)
240> min. | | Different |
| | Vinblastine 1 mg/ml
(1,000 ppm)
240> min. | | Different |
| | Vincristine Sulfate 1.0 mg/ml
(1,000 ppm)
240 min. | Vincristine Sulfate 1.0 mg/ml
(1,000 ppm)
240 min. | Same |
| | Vinorelbine 10.0 mg/ml (10,000 ppm)
240> min. | | Different |
| | Zoledronic Acid 0.8 mg/ml (800 ppm)
240> min. | | Different |
| Fentanyl Testing | Fentanyl Citrate,
100.0 mcg/2mL
240 min. | | Different |
TABLE 3: Comparison of Proposed – VS311 and Predicate Device
12
Image /page/12/Picture/0 description: The image shows the Medline logo. The logo features the word "MEDLINE" in a sans-serif font, with the letters in white against a blue background. To the right of the word is a white, four-pointed star-like symbol. The background is a solid blue color.
13
Image /page/13/Picture/0 description: The image features the Medline logo, set against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized white symbol that resembles a starburst or a stylized medical cross. The overall design is clean and professional, conveying a sense of reliability and expertise often associated with healthcare and medical information.
14
Image /page/14/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with a stylized white starburst symbol behind it. The background is a solid dark blue color. The logo is simple and modern, and the colors are clean and professional.
15
Image /page/15/Picture/0 description: The image features the Medline logo, set against a blue background. The logo consists of the word "MEDLINE" in bold, white letters, positioned to the left of a stylized white starburst symbol. The starburst is composed of four elongated, pointed shapes converging at a central point, creating a dynamic and modern design.
16
Image /page/16/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in bold, white sans-serif font, positioned to the left of a white, stylized starburst or cross shape. The starburst/cross has four points, each formed by two converging lines, creating a symmetrical design. The overall impression is clean and professional, typical of a healthcare or medical supply company.
17
Image /page/17/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with a stylized white starburst or cross shape positioned below the text. The background is a solid dark blue color. The logo is simple and modern, with a clean design.
TABLE 4: Comparison of Proposed – VS711 and Predicate Device
| Device
Characteristic | Proposed
Device
VS711 | Predicate
Device | Comparison Analysis |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Product Name | Medline Powder-Free Blue
Nitrile Examination Gloves
(Tested for use with
Chemotherapy Drugs and
Fentanyl)
Extended Cuff | Non-Sterile, Powder-Free
Nitrile Examination Gloves
(Cobalt)Tested for use with
chemotherapy drugs | N/A |
| 510(k) Reference | K193666 | K111248 | N/A |
| Product Owner | Medline Industries, Inc. | YTY Industry (Manjung) SDN,
BHD | N/A |
| Product Code | LZA, OPJ, QDO | LZA, LZC | Similar |
| 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
and Fentanyl Citrate as per
ASTM D6978-05 (Reapproved
2019) Standard Practice for
Assessment of Medical Gloves
of Permeation by
Chemotherapy Drugs | A patient examination glove is
a disposable device intended
for medical purposes that is
worn on the examiner's hand
or fingers to prevent
contamination between
patient and examiner.
These glove were tested for
use with chemotherapy drugs. | Same |
| Regulation
Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Materials | Powder-Free Nitrile | Powder-Free Nitrile | Same |
| Color | Blue | Blue | Same |
| Sizes | x- small, small, medium, large,
x-large | Medium, Large, Extra-large | Similar |
| Dimensions -
Length | Complies with:
ASTM D6319-10
230mm min | Complies with:
ASTM D6319-10
230mm min. | Same. |
| | | | |
| Dimensions – Width | Complies with:
ASTM D6319-10
70mm min | Complies with:
ASTM D6319-10
70mm min | Same |
| Dimensions – Thickness | Complies with:
ASTM D6319-10
Palm – 0.05mm min.
Finger – 0.05mm min. | Complies with:
ASTM D6319-10
Palm – 0.05mm min.
Finger – 0.05mm min. | Same |
| | Complies with:
ASTM D6319-10 minimum: | Complies with:
ASTM D6319-10 minimum: | |
| Physical
Properties | Tensile Strength:
Before Aging ≥14 MPa, min.
After Aging ≥14 MPa, min.
Elongation:
Before Aging 500%, min.
After Aging 400%, min. | Tensile Strength:
Before Aging ≥14 MPa, min.
After Aging ≥14 MPa, min.
Elongation:
Before Aging 500% min.
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 2.5 | Same |
| Powder or
Powder-Free | Powder-Free | Powder-Free | Same |
| Residual Powder | Complies with:
ASTM D6319-10
240 min. | | Different |
| | Azacitidine (Vidaza) 25.0 mg/ml
(25,000 ppm) | | Different |
| | | | |
| Bendamustine 5.0 mg/ml (5,000 ppm)
240 min. | | Different | |
| Bleomycin 15.0 mg/ml (15,000 ppm)
240 min. | | Different | |
| Bortezomib 1.0 mg/ml
(1,000 ppm)
240 min. | | Different | |
| Busulfan 6.0 mg/ml
(6,000 ppm)
240 min. | | Different | |
| Carboplatin 10mg/ml
10,000 ppm
240 min | Carboplatin 10mg/ml
10,000 ppm
240 min | Same | |
| Carfilzomib 2.0 mg/ml
(2,000 ppm)
240 min. | | Different | |
| Carmustine (BCNU) 3.3 mg/ml
(3,300 ppm)
59.4 min. | Carmustine (BCNU) 3.3 mg/ml
(3,300 ppm)
1.82 min | Similar | |
| Cetuximab 2.0 mg/ml
(2,000 ppm)
240 min | | Different | |
| Cisplatin 1.0 mg/ml
(1,000 ppm)
240 min. | Cisplatin 1.0 mg/ml
(1,000 ppm)
240 min. | Same | |
| Cyclophosphamide (Cytoxan)
20.0 mg/ml
(20,000 ppm)
240 min. | Cyclophosphamide (Cytoxan)
20.0 mg/ml
(20,000 ppm)
240 min. | Same | |
| Cytarabine 100.0 mg/ml
(100,000 ppm)
240 min. | | Different | |
| Cytovene 10.0 mg/ml
(10,000 ppm)
240 min. | | Different | |
| Dacarbazine (DTIC) 10.0 mg/ml
(10,000 ppm)
240 min. | Dacarbazine (DTIC) 10 mg/ml
(10,000 ppm)
240 min. | Same | |
| | | | |
| Daunorubicin 5.0 mg/ml
(5,000 ppm)
240 min. | | Different | |
| Decitabine 5.0 mg/ml
(5,000 ppm)
240 min. | | Different | |
| Docetaxel 10.0 mg/ml
(10,000 ppm)
240 min. | | Different | |
| Doxorubicin Hydrochloride 2.0 mg/ml
(2,000 ppm)
240 min. * | Doxorubicin Hydrochloride 2.0 mg/ml
(2,000 ppm)
240 min | Same | |
| Epirubicin (Ellence)
2.0 mg/ml
(2,000 ppm)
240 min. | | Different | |
| Etoposide (Toposar)
20.0 mg/ml
(20,000 ppm)
240 min. * | Etoposide (Toposar)
20.0 mg/ml
(20,000 ppm)
240 min. | Same | |
| Fludarabine 25.0 mg/ml
(25,000 ppm)
240 min. | | Different | |
| Fluorouracil 50.0 mg/ml
(50,000 ppm)
240 min. | Fluorouracil 50.0 mg/ml
(50,000 ppm)
240 min. | Same | |
| Fulvestrant 50.0 mg/ml (50,000 ppm)
240 min. | | Different | |
| Gemcitabine (Gemzar) 38.0 mg/ml
(38,000 ppm)
240 min. | | Different | |
| Idarubicin 1.0 mg/ml
(1,000 ppm)
240 min. | | Different | |
| Irinotecan 20.0 mg/ml
(20,000 ppm)
240 min | | Different | |
| Mechlorethamine HCl 1.0
mg/ml
(1,000 ppm)
240 min. | | Different | |
| Melphalan 5.0 mg/ml
(5,000 ppm)
240 min. | | Different | |
| Methotrexate 25.0 mg/ml
(25,000 ppm)
240 min. * | Methotrexate 25.0 mg/ml
(25,000 ppm)
240 min. | Same | |
| Mitomycin C 0.5 mg/ml
(500 ppm)
240 min. | Mitomycin C 0.5 mg/ml
(2,000 ppm)
240 min. | Same | |
| Oxaliplatin 2.0 mg/ml
(2,000 ppm)
240 min. | | Different | |
| Paclitaxel (Taxol) 6.0 mg/ml
(6,000 ppm)
240 min. | Paclitaxel (Taxol) 6.0 mg/ml
(6,000 ppm)
240 min. | Same | |
| Paraplatin 10.0 mg/ml
(10,000 ppm)
240 min. | | Different | |
| Pemetrexed Disodium 25.0
mg/ml
(25,000 ppm)
240 min. | | Different | |
| Pertuzumab 30.0 mg/ml
(30,000 ppm)
240 min. | | Different | |
| Raltitrexed 0.5 mg/ml
(500 ppm)
240> min. | | Different | |
| Retrovir 10.0 mg/ml
(10,000 ppm)
240> min. | | Different | |
| Rituximab 10.0 mg/ml (10,000
ppm)
240> min. | | Different | |
| Temsirolimus 25.0 mg/ml
(25,000 ppm)
240> min. | | Different | |
| | Thiotepa (THT) 10.0 mg/ml
(10,000 ppm)
68.2 min. | Thiotepa 10.0 mg/ml
(10,000 ppm)
0.93 min | Similar |
| | Topotecan HCI 1.0 mg/ml
(1,000 ppm)
240> min. | | Different |
| | Trastuzumab 21.0 mg/ml
(21,000 ppm)
240> min. | | Different |
| | Trisonex 1.0 mg/ml
(1,000 ppm)
240> min. | | Different |
| | Vinblastine 1 mg/ml
(1,000 ppm)
240> min. | | Different |
| | Vincristine Sulfate 1.0 mg/ml
(1,000 ppm)
240 min. | Vincristine Sulfate 1.0 mg/ml
(1,000 ppm)
240 min. | Same |
| | Vinorelbine 10.0 mg/ml (10,000 ppm)
240> min. | | Different |
| | Zoledronic Acid 0.8 mg/ml (800 ppm)
240> min. | | Different |
| Fentanyl Testing | Fentanyl Citrate,
100.0 mcg/2mL
240 min. | | Different |
18
Image /page/18/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo is set against a blue square background. The word "MEDLINE" is prominently displayed in a sans-serif font, positioned to the left of a stylized white starburst symbol. The starburst is composed of four triangular shapes converging at a central point, creating a dynamic and modern visual element.
19
Image /page/19/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 white, stylized starburst symbol. The starburst is composed of four elongated triangles converging at a central point, creating a dynamic and modern design.
20
Image /page/20/Picture/0 description: The image features the Medline logo, set against a blue background. The logo consists of the word "MEDLINE" in bold, white letters, positioned to the left of a stylized white starburst symbol. The starburst is composed of four elongated, pointed shapes converging at a central point, creating a dynamic and modern design.
21
Image /page/21/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in bold, white sans-serif font, positioned to the left of a white, stylized starburst or cross-like symbol. The symbol is composed of four pointed shapes converging at a central point, creating a visual effect reminiscent of a compass rose or a medical cross. The overall design is clean and corporate, conveying a sense of professionalism and reliability.
22
Image /page/22/Picture/0 description: The image features the Medline logo, set against a blue background. The logo consists of the word "MEDLINE" in bold, white letters, positioned to the left of a stylized white starburst symbol. The starburst is composed of four elongated, triangular shapes converging at a central point, creating a dynamic and modern design.
23
Image /page/23/Picture/0 description: The image features the Medline logo, which is set against a dark blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized white starburst symbol. The starburst has four points, resembling a compass rose, and is oriented vertically. The overall design is clean and professional, reflecting the company's focus on medical supplies and services.
Summary of Non-Clinical Testing:
Biocompatibility Testing
Table 5 below summarize the biocompatibility results for the Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) – Regular Cuff and the Medline Powder-Free Blue Nitrile Examination Gloves-(Tested for use with Chemotherapy Drugs and Fentanyl) — Extended Cuff
24
Image /page/24/Picture/0 description: The image is a logo for Medline. The logo is a blue square with the word "MEDLINE" in white, sans-serif font on the upper left. A white, stylized cross is behind the text, with the top and bottom points of the cross extending beyond the text. There is a gray rectangle on the right side of the image.
Table 5: Biocompatibility Testing – VS311 & VS711
| Name of Test
/ Citation | Purpose | Acceptance
Criteria | Results |
|-----------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------|-------------------------------------------------------------------------------------------------------|
| ISO 10993-10: 2010 Biological
Evaluation of Medical Devices,
Part 10-Tests for Irritation and
Skin Sensitization | Irritation
Testing | Pass/Fail | Pass
Under the conditions of the
study, the subject device is not
a primary skin irritant. |
| ISO 10993-10:2010. Biological
Evaluation of Medical Devices,
Part 10: Tests for Irritation and
Skin Sensitization. | Sensitization
Testing | Pass/Fail | Pass
Under the conditions of the
study, the subject device is not
a primary skin sensitizer. |
| ISO 10993-5:2009
Biological Evaluation
of Medical Devices,
Part 5: Tests for In
Vitro Cytotoxicity | Cytotoxicity
Testing | Pass/Fail | Failed
Under the conditions of the
study, the subject device is
cytotoxic. |
| ISO 10993-11: 2017 Biological
Evaluation of Medical Devices
Part 11: Tests for Systemic
Toxicity. | Systemic
Toxicity Testing | Pass/Fail | Pass
Under the conditions of the
study, the subject device is not
toxic. |
Table 6: Quality Assurance Testing For Finished Gloves
| Characteristics | Reference Test
Method & Sampling | Inspection Level | Inspection Level | Acceptance
Criteria |
|------------------------------------------------|---------------------------------------------------|------------------|------------------|---------------------------|
| Dimension (length, width, thickness) | ASTM D6319 – 10
(2015) | S-2 | 4.0 | Meet Acceptance
Number |
| Tensile strength and
Ultimate
elongation | ASTM D 6319 – 10
(2015) | S-2 | 4.0 | Meet Acceptance
Number |
| Water Leak | ASTM D 5151-06
(2015)
and
ASTM D 6319-10 | G-1 | 1.5 | Meet Acceptance
Number |
| Powder Residue | ASTM D6124 - 06
(2011) | N/A | N/A | 2 mg/glove |
25
Image /page/25/Picture/0 description: The image shows the Medline logo. The logo is white text on a blue background. The text "MEDLINE" is in a sans-serif font. There is a white cross-like shape behind the text. The cross shape is stylized, with the top and bottom points being longer than the side points.
Medline Industries, Inc.
Three Lakes Drive
Northfield, IL 60093
Physical Dimensions
Thirteen (13) glove samples of each size (extra-small, small, medium, large and extra-large) were tested for physical dimensions according to ASTM D6319-10. All samples from each of the five size gloves met the specifications for physical dimensions.
Tables 7 through 16 below summarize the physical dimension results for the Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) – Regular Cuff and the Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff.
| Characteristic | Device Specification | Average Device
Performance (n=13) | Complies with
Standard (Y/N) |
|------------------|----------------------|--------------------------------------|---------------------------------|
| Glove Length | 220mm min. | 247mm | Yes |
| Palm Width | $70 \pm 10mm$ | 78mm | Yes |
| Thickness Finger | 0.05mm min. | 0.16mm | Yes |
| Thickness Palm | 0.05mm min. | 0.11mm | Yes |
TABLE 7: ASTM D6319-10 Test Results - Extra-Small, VS311XS (Regular Cuff)
TABLE 8: ASTM D6319-10 Test Results - Small, VS311S (Regular Cuff)
| Characteristic | Device Specification | Average Device Performance (n=13) | Complies with Standard (Y/N) |
|---|---|---|---|
| Glove Length | 220mm min. | 248mm | Yes |
| Palm Width | $80 \pm 10mm$ | 86mm | Yes |
| Thickness Finger | 0.05mm min | 0.16mm | Yes |
| Thickness Palm | 0.05mm min | 0.11mm | Yes |
TABLE 9: ASTM D6319-10 Test Results – Medium, VS311M (Regular Cuff)
| Characteristic | Device Specification | Average Device
Performance (n=13) | Complies with
Standard (Y/N) |
|------------------|----------------------|--------------------------------------|---------------------------------|
| Glove Length | 230mm min. | 250mm | Yes |
| Palm Width | 95 ± 10mm | 97mm | Yes |
| Thickness Finger | 0.05mm | 0.15mm | Yes |
| Thickness Palm | 0.05mm | 0.11mm | Yes |
26
Image /page/26/Picture/0 description: The image is a logo for Medline. The logo features the word "MEDLINE" in a sans-serif font, with the letters stacked vertically. A white star-like shape is behind the text. The background of the logo is a dark blue color.
TABLE 10: ASTM D6319-10 Test Results – Large, VS311L (Regular Cuff)
| Characteristic | Device Specification | Average Device
Performance (n=13) | Complies with
Standard (Y/N) |
|------------------|----------------------|--------------------------------------|---------------------------------|
| Glove Length | 230mm min. | 250mm | Yes |
| Palm Width | $110 \pm 10mm$ | 107mm | Yes |
| Thickness Finger | 0.05mm | 0.16mm | Yes |
| Thickness Palm | 0.05mm | 0.11mm | Yes |
TABLE 11: ASTM D6319-10 Test Results – Extra-Large, VS311XL (Regular Cuff)
| Characteristic | Device Specification | Average Device Performance (n=13) | Complies with Standard (Y/N) |
|---|---|---|---|
| Glove Length | 230mm min. | 251mm | Yes |
| Palm Width | $120 \pm 10mm$ | 119mm | Yes |
| Thickness Finger | 0.05mm | 0.15mm | Yes |
| Thickness Palm | 0.05mm | 0.11mm | Yes |
TABLE 12: ASTM D6319-10 Test Results – Extra-Small, VS711XS (Extended Cuff)
| Characteristic | Device Specification | Average Device Performance (n=13) | Complies with Standard (Y/N) |
|---|---|---|---|
| Glove Length | 220mm min. | 302mm | Yes |
| Palm Width | $70 \pm 10mm$ | 78mm | Yes |
| Thickness Finger | 0.05mm min. | 0.17mm | Yes |
| Thickness Palm | 0.05mm min. | 0.12mm | Yes |
TABLE 13: ASTM D6319-10 Test Results - Small, VS711S (Extended Cuff)
| Characteristic | Device Specification | Average Device
Performance (n=13) | Complies with
Standard (Y/N) |
|------------------|----------------------|--------------------------------------|---------------------------------|
| Glove Length | 220mm | 300mm | Yes |
| Palm Width | $80 \pm 10mm$ | 89mm | Yes |
| Thickness Finger | 0.05mm min. | 0.18mm | Yes |
| Thickness Palm | 0.05mm min. | 0.12mm | Yes |
27
Image /page/27/Picture/0 description: The image features the Medline logo, which is set against a blue square. The word "MEDLINE" is prominently displayed in white, with a stylized white symbol resembling a starburst or intersecting lines positioned above the text. The overall design is clean and corporate, suggesting a professional and established brand identity.
TABLE 14: ASTM D6319-10 Test Results – Medium, VS711M (Extended Cuff)
| Characteristic | Device Specification | Average Device
Performance (n=13) | Complies with
Standard (Y/N) |
|------------------|----------------------|--------------------------------------|---------------------------------|
| Glove Length | 230mm min. | 301mm | Yes |
| Palm Width | $95 \pm 10mm$ | 99mm | Yes |
| Thickness Finger | 0.05mm | 0.18mm | Yes |
| Thickness Palm | 0.05mm | 0.13mm | Yes |
TABLE 15: ASTM D6319-10 Test Results – Large, VS711L (Extended Cuff)
| Characteristic | Device Specification | Average Device Performance (n=13) | Complies with Standard (Y/N) |
|---|---|---|---|
| Glove Length | 230mm min. | 299mm | Yes |
| Palm Width | $110 \pm 10$ mm | 108mm | Yes |
| Thickness Finger | 0.05mm | 0.16mm | Yes |
| Thickness Palm | 0.05mm | 0.12mm | Yes |
TABLE 16: ASTM D6319-10 Test Results – Extra-Large, VS711XL (Extended Cuff)
| Characteristic | Device Specification | Average Device
Performance (n=13) | Complies with
Standard (Y/N) |
|------------------|----------------------|--------------------------------------|---------------------------------|
| Glove Length | 230mm min. | 298mm | Yes |
| Palm Width | 120 ± 10mm | 115mm | Yes |
| Thickness Finger | 0.05mm | 0.18mm | Yes |
| Thickness Palm | 0.05mm | 0.23mm | Yes |
28
Image /page/28/Picture/0 description: The image is a logo for Medline. The logo is set on a blue square background. The word "MEDLINE" is in white, block letters on the left side of the square. To the right of the word is a white, stylized cross shape.
Three Lakes Drive Northfield. IL 60093
Freedom from Holes
Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) – Regular Cuff and Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff were tested for freedom from holes as per ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves and the FDA 1000ml Water Leak Test per 21 CFR 800.20. The results for all sizes (XS/S/M/L/XL) are summarized in Tables below.
TABLE 17: ASTM D5151 Freedom from Holes Test Results: PF Blue Nitrile Glove – Regular Cuff (VS311)
| Characteristic | Specification | Device Performance | Complies with Standard
(Y/N) |
|--------------------|-----------------------------------------------------------------|------------------------------------------------------------|---------------------------------|
| Freedom from Holes | ASTM D 5151-06 (2015)
and
ASTM D 6319-10, G-1,
AQL 1.5 | XS/Small/Medium – 1/200
Large – 4/400
X-Large -2/200 | Y |
TABLE 18: ASTM D5151 Freedom from Holes Test Results: PF Blue Nitrile Glove-Extended Cuff (VS711)
| Characteristic | Specification | Device Performance | Complies with Standard
(Y/N) |
|--------------------|-----------------------------------------------------------------|-------------------------------------------|---------------------------------|
| Freedom from Holes | ASTM D 5151-06 (2015)
and
ASTM D 6319-10, G-1,
AQL 1.5 | XS/Small/Medium, Large,
X-Large -0/200 | Y |
Powder Content
Residual powder content for the Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentany) – Regular Cuff and Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff was confirmed in accordance with ASTM D6124-06, Standard Test Method for Residual Powder on Medical Gloves. The average results for all sizes (XS/S/M/L/XL) are summarized below.
TABLE 19: ASTM D6124 Residual Powder Test Results: PF Blue Nitrile Glove – Regular Cuff (VS311)
| Characteristic | Specification | Device Performance | Complies with Standard
(Y/N) |
|--------------------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Powder Content per Glove | Less Than 2mg/glove | X-Small - 0.16 mg/glove
Small – 0.20 mg/glove
Medium – 0.16 mg/glove
Large – 0.16 mg/glove
X-Large — 0.18 mg/glove | Y |
29
Image /page/29/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. A white, stylized starburst symbol is behind the text, with the center of the starburst aligned with the center of the word "MEDLINE". There is a gray rectangle on the right side of the image.
Northfield II 60093
|--|--|--|--|
TABLE 20: ASTM D6124 Residual Powder Test Results: PF Blue Nitrile Glove-Extended Cuff (VS711)
| Characteristic | Specification | Device Performance | Complies with Standard
(Y/N) |
|--------------------------|---------------------|------------------------------------------------------------------------------|---------------------------------|
| Powder Content per Glove | Less Than 2mg/glove | X-Small- 0.16
Small- 0.20
Medium- 0.16
Large- 0.18
X-Large- 0.18 | Y |
Permeation Testing
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs and Fentanyl. The gloves were tested according to ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times were determined for a wide range of chemotherapy drugs and Fentanyl. A summary of the minimum breakthrough times is provided in Table 21 and Table 22 (below).
Please note that the following drug, Carmustine and Thiotepa have a low permeation time. Labeling will include caution statement in the presence of these chemotherapy drugs.
TABLE 21: Chemotherapy Drugs/Fentanyl Tested – Regular Cuff (VS311XS, VS311S, VS311M, VS311L and VS311XL)
Summarized in Table 21 below are the drugs the proposed devices have been tested for use with per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug Tested | Breakthrough Time(minutes) |
|---|---|
| Aresenic Trioxide 1 mg/ml (1,000 ppm) | >240 |
| Azacitidine 25 mg/ml (25,000 ppm) | >240 |
| Bendamustine 5 mg/ml (5,000 ppm) | >240 |
| Bleomycin 15 mg/ml (15,000 ppm) | >240 |
| Bortezomib 1 mg/ml (1,000 ppm) | >240 |
| Busulfan 6 mg/ml (6,000 ppm) | >240 |
| Carboplatin 10.0 mg/ml (10,000 ppm) | >240 |
| Carfilzomib 2.0 mg/ml (2,000) | >240 |
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 33.1 min |
| Cetuximab 2.0 mg/ml (2,000) | >240 |
| Cisplatin 1.0 mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml (20,000 ppm) | >240 |
| Cytarabine 100 mg/ml (100,000 ppm) | >240 |
| Cytovene 10 mg/ml (10,000 ppm) | >240 |
| Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) | >240 |
| Daunorubicin 5 mg/ml (5,000 ppm) | >240 |
| Decitabine 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel 10.0 mg/ml (10,000 ppm) | >240 |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | >240 |
| Epirubicin (Ellence) 2.0 mg/ml (2,000 ppm) | >240 |
| Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) | >240 |
| Fludarabine 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil 50.0 mg/ml (50,000 ppm) | >240 |
| Fulvestrant 50.0 mg/ml (50,000 ppm) | >240 |
| Gemcitabine (Gemzar) 38 mg/ml (38,000 ppm) | >240 |
| Idarubicin 1 mg/ml (1,000 ppm) | >240 |
| Ifosfamide 50.0 mg/ml (50,000 ppm) | >240 |
| Irinotecan 20.0 mg/ml (20,000 ppm) | >240 |
| Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) | >240 |
| Melphalan 5 mg/ml (5,000 ppm) | >240 |
| Methotrexate 25 mg/ml (25,000 ppm) | >240 |
| Mitomycin C 0.5 mg/ml (500 ppm) | >240 |
| Mitoxantrone 2.0 mg/ml (2,000 ppm) | >240 |
| Oxaliplatin 2.0 mg/ml (2,000 ppm) | >240 |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | >240 |
| Paraplatin 10 mg/ml (10,000 ppm) | >240 |
| Pemetrexed Disodium 25.0 mg/ml (25,000 ppm) | >240 |
| Pertuzumab 30 mg/ml (30,000 ppm) | >240 |
| Raltitrexed 0.5 mg/ml (500 ppm) | >240 |
| Retrovir 10.0 mg/ml (10,000 ppm) | >240 |
| Rituximab 10 mg/ml (10,000 ppm) | >240 |
| Temsirolimus 25.0 mg/ml (25,000 ppm) | >240 |
| Thiotepa 10.0 mg/ml (10,000 ppm) | 69.2 min |
| Topotecan HCI 1.0 mg/ml (1,000 ppm) | >240 |
| Trastuzumab 21.0 mg/ml (21,000 ppm) | >240 |
| Trisonex 1 mg/ml (1,000 ppm) | >240 |
| Vinblastine 1 mg/ml (1,000 ppm) | >240 |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | >240 |
| Vinorelbine 10 mg/ml (10,000 ppm) | >240 |
| Zoledronic Acid 0.8 mg/ml (800 ppm) | >240 |
| Fentanyl Tested | Breakthrough Time |
| (in minutes) | |
| Fentanyl Citrate, 100mcg/2mL | >240 |
30
Image /page/30/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in white, set against a dark blue square background. A white star-like symbol is positioned above the text, with its points extending beyond the word. A gray rectangle is visible on the right side of the image.
31
Image /page/31/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized star-like symbol. The star has four points, each formed by two lines converging at a sharp angle, creating a sense of dynamism. A small gray rectangle is visible in the upper right corner of the image.
TABLE 22: Chemotherapy/Fentanyl Drugs Tested – Extended Cuff (VS311XS, VS311S, VS311M, VS311L and VS311XL)
Summarized in 18 below, are the drugs the proposed devices have been tested for use with per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug Tested | Breakthrough Time
(in minutes) |
|---------------------------------------|-----------------------------------|
| Aresenic Trioxide 1 mg/ml | >240 |
| Azacitidine 25 mg/ml | >240 |
| Bendamustine 5 mg/ml | >240 |
| Bleomycin 15 mg/ml | >240 |
| Bortezomib 1 mg/ml | >240 |
| Busulfan 6 mg/ml | >240 |
| Carfilzomib 2 mg/ml | >240 |
| Carmustine (BCNU) 3.3 mg/ml | 59.4 min |
| Cetuximab | >240 |
| Cisplatin 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml | >240 |
| Cytarabine Hydrochloride 100 mg/ml | >240 |
| Cytovene 10 mg/ml | >240 |
| Dacarbazine (DTIC) 10.0 mg/ml | >240 |
| Daunorubicin 5 mg/ml | >240 |
| Decitabine 5 mg/ml | >240 |
| Docetaxel 10.0 mg/ml | >240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | >240 |
| Epirubicin (Ellence) 2.0 mg/ml | >240 |
| Etoposide (Toposar) 20.0 mg/ml | >240 |
| Fludarabine 25 mg/ml | >240 |
| Fluorouracil 50.0 mg/ml | >240 |
| Fulvestrant 50.0 mg/ml | >240 |
| Gemcitabine (Gemzar) 38 mg/ml | >240 |
| Idarubicin 1 mg/ml | >240 |
| Irinotecan 20.0 mg/ml | >240 |
| Mechlorethamine HCI 1.0 mg/ml | >240 |
| Melphalan 5 mg/ml | >240 |
| Methotrexate 25.0 mg/ml | >240 |
| Mitomycin C 0.5 mg/ml | >240 |
| Oxaliplatin 5.0 mg/ml | >240 |
| Paclitaxel (Taxol) 6.0 mg/ml | >240 |
| Paraplatin (Carboplatin) 10 mg/ml | >240 |
| Pemetrexed Disodium 25.0 mg/ml | >240 |
| Pertuzumab 30 mg/ml | >240 |
| Raltitrexed 0.5 mg/ml | >240 |
| Retrovir 10.0 mg/ml | >240 |
| Rituximab 10 mg/ml | >240 |
| Temsirolimus 25.0 mg/ml | >240 |
| Thiotepa 10.0 mg/ml | 68.2 min |
| Topotecan HCI 1.0 mg/ml | >240 |
| Trastuzumab 21.0 mg/ml | >240 |
| Trisonex 1 mg/ml | >240 |
| Vinblastine 1 mg/ml | >240 |
| Vincristine Sulfate 1.0 mg/ml | >240 |
| Vinorelbine 10 mg/ml | >240 |
| Zoledronic Acid 0.8 mg/ml | >240 |
| Fentanyl Tested | Breakthrough Time
(in minutes) |
32
Image /page/32/Picture/0 description: The image features the Medline logo, which is set against a blue background. The word "MEDLINE" is prominently displayed in white, bold letters. Above the text is a white, star-like symbol with four points, adding a distinctive visual element to the logo. A small gray rectangle is visible on the right edge of the image.
33
Image /page/33/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, set against a blue background. To the right of the word is a white star-like shape with four points. There is a gray bar on the right side of the logo.
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that The Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) – Regular Cuff and the Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff are as safe, as effective, and performs as well as or better than the legally marketed predicate device, the YTY Industry (Manjung) Non-Sterile, Powder-Free Nitrile Examination Gloves (Cobalt Blue) Tested for use with Chemotherapy Drugs – K111248.