(114 days)
Not Found
No
The device is a medical glove, and the description focuses on its physical properties and testing for chemotherapy drug permeation, with no mention of AI or ML.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
The device is described as a "patient examination glove" intended to "prevent contamination between patient and examiner." Its function is protective, not diagnostic.
No
The device is a physical examination glove, which is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a patient examination glove. Its purpose is to create a physical barrier between the examiner and the patient to prevent contamination. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's for preventing contamination between patient and examiner, not for diagnostic testing.
- Performance Studies: The performance studies focus on the physical properties of the glove and its resistance to chemotherapy drugs, not on the analysis of biological samples.
The fact that the gloves are tested for use with chemotherapy drugs is a safety feature related to their barrier function, not an indication of diagnostic capability.
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 hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Carmustine (BCNU) 3.3 mg/ml 25.3 Minutes Cisplatin 1.0 mg/ml ≥ 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml ≥ 240 Minutes Dacarbazine (DTIC) 10.0 mg/ml ≥ 240 Minutes Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Minutes Etoposide (Toposar) 20.0 mg/ml ≥ 240 Minutes Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes Methotrexate 25 mg/ml ≥ 240 Minutes Mitomycin C 0.5 mg/ml ≥ 240 Minutes Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes Thio-Tepa 10.0 mg/ml 43.7 Minutes Vincristine Sulfate (Oncovin) 1.0 mg/ml ≥ 240 Minutes
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 25.3 Minutes Thio-Tepa 10.0 mg/ml 43.7 Minutes
Caution: Testing showed an average breakthrough time of 43.7 minutes with Thio-Tepa WARNING: Do not use with Carmustine
Product codes
LZA, LZC
Device Description
The Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) are single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, light blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: 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
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / Not Found
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
The biocompatibility evaluation for Medline Powder-Free Light Blue (Tested for Use with Chemotherapy Drugs) was conducted in accordance with ANSI/AAMI/ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation within a Risk Management Process, as recognized by FDA. The following tests were performed to evaluate the biocompatibility of the Medline Powder-Free Light Blue Nitrile Exam Glove (Tested for Use with Chemotherapy Drugs): ISO 10993-10: Primary Skin Irritation, ISO 10993-10: Dermal Sensitization, ISO 10993-05: Cytotoxicity.
Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs.
In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below: ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application, ASTM D 6124-06 (Reapproved 2011) Standard Test Method for Residual Powder on Medical Gloves, ASTM D 5151-06 (Reapproved 2011) Standard Test Method for Detection of Holes in Medical Gloves, ASTM D 6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
No clinical study is included in this submission.
Key Metrics
- Carmustine (BCNU) 3.3 mg/ml breakthrough time: 25.3 Minutes
- Cisplatin 1.0 mg/ml breakthrough time: ≥ 240 Minutes
- Cyclophosphamide (Cytoxan) 20.0 mg/ml breakthrough time: ≥ 240 Minutes
- Dacarbazine (DTIC) 10.0 mg/ml breakthrough time: ≥ 240 Minutes
- Doxorubicin Hydrochloride 2.0 mg/ml breakthrough time: ≥ 240 Minutes
- Etoposide (Toposar) 20.0 mg/ml breakthrough time: ≥ 240 Minutes
- Fluorouracil 50.0 mg/ml breakthrough time: ≥ 240 Minutes
- Methotrexate 25 mg/ml breakthrough time: ≥ 240 Minutes
- Mitomycin C 0.5 mg/ml breakthrough time: ≥ 240 Minutes
- Paclitaxel (Taxol) 6.0 mg/ml breakthrough time: ≥ 240 Minutes
- Thio-Tepa 10.0 mg/ml breakthrough time: 43.7 Minutes
- Vincristine Sulfate (Oncovin) 1.0 mg/ml breakthrough time: ≥ 240 Minutes
- Residual Powder: Max. 0.52mg per glove
- Tensile Strength: Before Aging ≥17 MPa, min; After Aging ≥14 MPa, min
- Elongation: Before Aging 500% Min; After Aging 400% Min
- Freedom from Holes: AQL 2.5
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 & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 18, 2020
Medline Industires, Inc. Adam Ostrower Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K201390
Trade/Device Name: Medline Powder-Free Light Blue Nitrile Exam 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 Dated: June 24, 2020 Received: June 25, 2020
Dear Adam Ostrower:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
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 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) K201390
Device Name
Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy)
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Carmustine (BCNU) 3.3 mg/ml 25.3 Minutes Cisplatin 1.0 mg/ml ≥ 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml ≥ 240 Minutes Dacarbazine (DTIC) 10.0 mg/ml ≥ 240 Minutes Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Minutes Etoposide (Toposar) 20.0 mg/ml ≥ 240 Minutes Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes Methotrexate 25 mg/ml ≥ 240 Minutes Mitomycin C 0.5 mg/ml ≥ 240 Minutes Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes Thio-Tepa 10.0 mg/ml 43.7 Minutes Vincristine Sulfate (Oncovin) 1.0 mg/ml ≥ 240 Minutes
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 25.3 Minutes Thio-Tepa 10.0 mg/ml 43.7 Minutes
Caution: Testing showed an average breakthrough time of 43.7 minutes with Thio-Tepa WARNING: Do not use with Carmustine
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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Image /page/3/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, sans-serif font, stacked on top of a white, stylized starburst shape. The background is a solid dark blue color. The logo is simple and modern, and the colors are clean and professional.
Medline Industries, Inc.
Three Lakes Drive
Northfield, IL 60093
510(k) SUMMARY (K201390) [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
Registration Number: 1417592
Contact Person
Adam Ostrower Regulatory Affairs Sr. Specialist Phone: 224-931-1176 Email: aostrower@medline.com
Summary Preparation Date September 18, 2020
Type of 510(k) Submission Traditional
Device Name / Classification
Trade Name: Medline Powder-Free Light Blue Nitrile Exam Glove (Tested for Use with Chemotherapy Drugs) Common Name: Patient Examination Glove, Specialty Classification Name: Patient Examination Glove, Specialty Product Code: LZA, LZC Classification Panel: General Hospital Regulatory Class: I Regulation Number: 21 CFR 880.6250
Predicate Device
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs – K172525
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Image /page/4/Picture/0 description: The image features the logo for Medline, a healthcare company. The logo is set against a blue square background. A white, stylized starburst or cross shape is prominently displayed, with the word "MEDLINE" in bold, white letters positioned horizontally across the center of the shape. A gray bar is visible on the right side of the image.
Medline Industries, Inc.
Three Lakes Drive
Northfield, IL 60093
Device Description
The Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) are single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, light blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.
Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, per ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| CHEMOTHERAPY DRUG TESTED | BREAKTHROUGH TIME (IN MINUTES) | |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 25.3 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | ≥ 240 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | ≥ 240 |
| Dacarbazine (DTIC) | 10.0 mg/ml (10,000 ppm) | ≥ 240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | ≥ 240 |
| Etoposide (Toposar) | 20.0 mg/ml (20,000 ppm) | ≥ 240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | ≥ 240 |
| Methotrexate | 25 mg/ml (25,000 ppm) | ≥ 240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | ≥ 240 |
| Paclitaxel (Taxol) | 6.0 mg/ml (6,000 ppm) | ≥ 240 |
| Thio-Tepa | 10.0 mg/ml (10,000 ppm) | 43.7 |
| Vincristine Sulfate (Oncovin) | 1.0 mg/ml (1,000 ppm) | ≥ 240 |
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 25.3 Minutes Thio-Tepa 10.0 mg/ml 43.7 Minutes
CAUTION: Testing showed an average breakthrough time of 43.7 minutes with Thio-Tepa WARNING: Do not use with Carmustine
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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, with a stylized star shape behind it. The star shape has four points, with the top and bottom points being longer than the side points.
Summary of Technological Characteristics
TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
| DEVICE
CHARACTERISTICS | PROPOSED DEVICE | PREDICATE DEVICE | COMPARISON
ANALYSIS |
|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Powder-Free Light Blue Nitrile
Exam Gloves (Tested for Use
with Chemotherapy Drugs) | Blue Non-Sterile Powder Free
Nitrile Examination Gloves
Tested for Use with
Chemotherapy Drugs | Similar |
| 510(k) Reference | K201390 | K172525 | |
| Product Owner | Medline Industries, Inc. | Central Medicare | Different |
| Product Code | LZA, LZC | LZA, LZC | Same |
| 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
as per ASTM D6978-05(2019)
Standard Practice for
Assessment of Resistance of
Medical Gloves to Permeation
by Chemotherapy Drugs. | Blue Non-Sterile Powder Free
Nitrile Examination Gloves
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. | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Materials | Nitrile | Nitrile | Same |
| Color | Light Blue | Blue | Similar |
| Sizes | Small, Medium, Large, Extra
Large | Extra-Small, Small, Medium,
Large, Extra Large | Similar |
| Dimensions - Length | Complies with ASTM D6319-10
240mm min. | Complies with ASTM D6319-
10
230mm min. | Different |
| Dimensions - Width | Complies with ASTM D6319-10
XS: N/A
S: 85±10
M: 95±10
L: 105±10
XL: 115±10 | Complies with ASTM D6319-
10
XS: 70±10
S: 80±10
M: 95±10
L: 110±10
XL: 120±10 | Similar |
| Dimensions -
Thickness | Complies with ASTM D6319-10
Palm - 0.14
Finger - 0.16
Cuff - 0.12 | Complies with ASTM D6319-
10
Palm - 0.06±10
Finger - 0.08±10
Cuff - 0.10±10 | Different |
| Physical Properties | Complies with ASTM D6319-10
minimum:
Tensile Strength:
Before Aging ≥17 MPa, min
After Aging ≥14 MPa, min
Elongation:
Before Aging 500% Min
After Aging 400% Min | Tensile Strength:
Before Aging ≥15 MPa, min
After Aging ≥14 MPa, min
Elongation:
Before Aging 500% Min
After Aging 400% Min | Similar |
| Disposable vs. Non-
Disposable | Disposable | Disposable | Same |
| Freedom from Holes | Complies with ASTM D6319-10
and ASTM D5151-06 G-1, AQL
2.5 | In accordance with ASTM
D5151-06, following ASTM
D6319 AQL 2.5/Inspection
Level G-1 | Same |
| Powder or Powder-
Free | Powder-Free | Powder-Free | Same |
| Residual Powder | Max. 0.52mg per glove | Max. 0.52mg per glove | Same |
| Contact Duration | Limited 24 hours | Limited 24 hours | Same |
| Biocompatibility | AAMI/ANSI/ISO 10993-10:
Not a skin irritant
Not a skin sensitizer
Cytotoxic
Non-Toxic | Not a skin irritant
Not a skin sensitizer | |
| Sterility | Non-Sterile | Non-Sterile | Same |
| | Carmustine (BCNU) 3.3 mg/ml:
25.3 Minutes | Carmustine (3.3 mg/ml): 12.4
Minutes | Different |
| | Cisplatin 1.0 mg/ml: ≥240
Minutes | Cisplatin (1.0 mg/ml): ≥240
Minutes | Same |
| | Cyclophosphamide (Cytoxan)
20.0 mg/ml: ≥240 Minutes | Cyclophosphamide (20
mg/ml) : ≥240 Minutes | Same |
| | Dacarbazine (DTIC) 10.0 mg/ml:
≥240 Minutes | Dacarbazine (10.0 mg/ml):
≥240 Minutes | Same |
| Chemotherapy Drugs
Tested with Minimum
Breakthrough
Detection Time as
Tested per ASTM D
6978 | Doxorubicin Hydrochloride 2.0
mg/ml: ≥240 Minutes | Doxorubicin HCI (2.0 mg/ml):
≥240 Minutes | Same |
| | Etoposide (Toposar) 20.0
mg/ml: ≥240 Minutes | Etoposide (20.0 mg/ml): ≥240
Minutes | Same |
| | Fluorouracil 50.0 mg/ml: ≥240
Minutes | Fluorouracil (50.0 mh/ml):
≥240 Minutes | Same |
| | Methotrexate 25 mg/ml: ≥240
Minutes | Not Tested | Different |
| | Mitomycin C 0.5 mg/ml: ≥ 240
Minutes | Not Tested | Different |
| | Not Tested | Mixotantrone (2.0 mg/ml):
≥240 Minutes | Different |
| | Paclitaxel (Taxol) 6.0 mg/ml:
≥240 Minutes | Paclitaxel (6.0 mg/ml): ≥240
Minutes | Same |
| Thio-Tepa 10.0 mg/ml: 43.7
Minutes | Thiotepa (10.0 mg/ml): 24.4
Minutes | Different | |
| Vincristine Sulfate (Oncovin) 1.0
mg/ml: ≥240 Minutes | Vincristine Sulfate (1.0
mg/ml): ≥240 Minutes | Same | |
6
Image /page/6/Picture/0 description: The image features the Medline logo, which is set against a blue background. The logo consists of the word "MEDLINE" in a bold, 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. A small portion of a gray rectangle is visible on the right edge of the image.
7
Image /page/7/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, sans-serif font, stacked on top of a white, stylized starburst shape. The background is a solid dark blue color. The logo is simple and modern, and the colors are clean and professional.
8
Image /page/8/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a bold, sans-serif font, placed on the left side of the image. To the right of the word is a white, stylized starburst shape. The background is a solid dark blue color.
Summary of Non-Clinical Testing
The biocompatibility evaluation for Medline Powder-Free Light Blue (Tested for Use with Chemotherapy Drugs) was conducted in accordance with ANSI/AAMI/ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation within a Risk Management Process, as recognized by FDA.
The following tests were performed to evaluate the biocompatibility of the Medline Powder-Free Light Blue Nitrile Exam Glove (Tested for Use with Chemotherapy Drugs):
- ISO 10993-10: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- ISO 10993-05: Cytotoxicity
Performance Testing (Bench)
Physical performance qualities of the proposed device were evaluated per ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.
Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs.
In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D 6124-06 (Reapproved 2011) Standard Test Method for Residual Powder on Medical Gloves
- ASTM D 5151-06 (Reapproved 2011) Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D 6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Summary of Clinical Testing
No clinical study is included in this submission.
9
Image /page/9/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo is set against a blue background and consists of the word "MEDLINE" in bold, sans-serif font, positioned to the left of a stylized white symbol that resembles a compass or a star. The symbol has four points, with the top and bottom points being longer than the side points. A small gray rectangle is visible in the upper right corner of the image.
Conclusion
In accordance with 21 CFR Part 807, and based on the nonclinical information provided in this premarket notification Medline Industries, Inc. concludes that Medline Powder-Free Light Blue Nitrile Exam Glove (Tested for Use with Chemotherapy Drugs) is as safe, as effective, and performs as well as or better for its intended use as the legally marketed predicate device, Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, K172525.