(94 days)
Not Found
No
The device is a medical glove and the description focuses on its physical properties and resistance to chemotherapy drugs. There is no mention of AI or ML.
No
The device is described as an examination glove intended to prevent contamination between patient and examiner, not to treat a condition or disease.
No
Explanation: The device described is a patient examination glove, which is intended to prevent contamination between the patient and the examiner. Its purpose is protective, not diagnostic.
No
The device is a physical examination glove, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "patient examination glove... worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier device for personal protection and infection control.
- Device Description: The description reinforces its function as a physical barrier (glove) worn on the hand.
- Performance Studies: The performance studies focus on the physical properties of the glove (per ASTM D6319) and its resistance to permeation by chemotherapy drugs (per ASTM D6978). These are tests related to the glove's barrier function and material properties, not diagnostic testing of a sample.
- Key Metrics: The key metric is "Breakthrough time for chemotherapy drugs," which measures the glove's ability to prevent substances from passing through it. This is a performance characteristic of a barrier device, not a diagnostic metric.
- No mention of analyzing biological samples: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This document does not mention any such analysis.
In summary, the device is a medical glove intended for protection, not for performing diagnostic tests on biological samples.
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.
Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Do Not Use with Carmustine or Thiotepa
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
The Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with Chemotherapy drugs) are nonsterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are dark blue, powder free, nitrile ambidextrous gloves with a beaded cuff. The gloves are offered in sizes small, medium, large, and extra extra extra large packaged in a chipboard box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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)
The biocompatibility evaluation for the Medline Nitrile Powder Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs) was conducted in accordance with ANSVAAMI/ISO 10993- 1:2018 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA.
The following tests were performed to evaluate the biocompatibility of the Medline Nitrile Powder Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs)
- · ISO 10993-10: Primary Skin Irritation
- · ISO 10993-10: Dermal Sensitization
- · ISO 10993-05: Cytotoxicity
- · ISO 10993-11: Systemic Toxicity
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 2013), 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medline Industries, Inc. Adam Ostrower Regulatory Affairs Sr. Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K200960
Trade/Device Name: Medline Nitrile Powder Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 7, 2020 Received: April 10, 2020
Dear Mr. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 mediation-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,
Elizabeth F. Claverie, MS Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200960
Device Name
Medline Nitrile Powder Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs)
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.
Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough time |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 12.4 minutes |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | >240 minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | >240 minutes |
| Dacarbazine (DTIC) | 10.0 mg/ml (10,000 ppm) | >240 minutes |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | >240 minutes |
| Etoposide (Toposar) | 20.0 mg/ml (20,000 ppm) | >240 minutes |
| Fluorouracil | 50.0 mg/ ml (50,000 ppm) | >240 minutes |
| Methotrexate | 25 mg/ml (25,000 ppm) | >240 minutes |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 minutes |
| Paclitaxel (Taxol) | 6.0 mg/ml (6,000 ppm) | >240 minutes |
| ThioTepa | 10.0 mg/ml (10,000 ppm) | 27.4 minutes |
| Vincristine Sulfate (Oncovin) | 1.0 mg/ml (1,000 ppm) | >240 minutes |
| Do Not Use with Carmustine or 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)
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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
Contact Person
Adam Ostrower Regulatory Affairs Sr. Specialist Phone: 224-931-1513 Email: aostrower@medline.com
Summary Preparation Date July 10th , 2020
Type of 510(k) Submission Traditional
Device Name / Classification
Trade Name: Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs) Common Name: Non-powdered patient examination glove Classification Name: Medical Gloves with Chemotherapy Labeling Claims – Test For Use with Chemotherapy Drugs Product Code: LZA. LZC Classification Panel: General Hospital Regulatory Class: Class I Regulation Number: 21 CFR 880.6250
Predicate Device
Medline Powder Free Blue Nitrile Examination Glove (Tested for use with Chemotherapy Drugs) K051378
Device Description
The Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with Chemotherapy drugs) are nonsterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are dark blue, powder free, nitrile ambidextrous gloves with a beaded cuff. The gloves are offered in sizes small, medium, large, and extra extra extra large packaged in a chipboard box.
4
The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013).
Indications for Use
The Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with Chemotherapy drugs) are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration | Breakthrough time |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 12.4 minutes |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | >240 minutes |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | >240 minutes |
| Dacarbazine (DTIC) | 10.0 mg/ml (10,000 ppm) | >240 minutes |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | >240 minutes |
| Etoposide (Toposar) | 20.0 mg/ml (20,000 ppm) | >240 minutes |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | >240 minutes |
| Methotrexate | 25 mg/ml (25,000 ppm) | >240 minutes |
| Mitomycin C | 0.5 mg/ml (500 ppm) | >240 minutes |
| Paclitaxel (Taxol) | 6.0 mg/ml (6,000 ppm) | >240 minutes |
| ThioTepa | 10.0 mg/ml (10,000 ppm) | 27.4 minutes |
| Vincristine Sulfate (Oncovin) | 1.0 mg/ml (1,000 ppm) | >240 minutes |
Do Not Use with Carmustine or Thiotepa
Summary of Technological Characteristics Table 2: Comparison of Proposed and Predicate Devices
| Device
Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Medline Nitrile Powder Free Dark Blue
Examination Gloves (Tested for use with
Chemotherapy Drugs) | Medline Powder Free Blue Nitrile Examination Glove
(Tested for use with Chemotherapy Drugs) | N/A |
| 510(k) Reference | K200960 | K051378 | N/A |
| Product Owner | Medline | Medline | Same |
| Product Code | LZA, LZC | LZA | 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. | 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. | Similar |
| Regulation
Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Design
Configurations | Dark Blue | Blue | Similar |
| Materials | Nitrile | Nitrile | Same |
| Prescription vs.
OTC | OTC | OTC | Same |
| Contact
Durations | Limited 240 minutes | | Cyclophosphamide | 20.0 mg/ml
(20,000 ppm) | No breakthrough up to
240 minutes | |
| | Cyclophosphamide
(Cytoxan) | 20.0 mg/ml
(20,000 ppm) | >240 minutes | | Doxorubicin
Hydrochloride | 2.0 mg/ml
(2,000 ppm) | No breakthrough up to
240 minutes | |
| | Dacarbazine
(DTIC) | 10.0 mg/ml
(10,000 ppm) | >240 minutes | | Etoposide | 20.0 mg/ml
(20,000 ppm) | No breakthrough up to
240 minutes | |
| | Doxorubicin
Hydrochloride | 2.0 mg/ml
(2,000 ppm) | >240 minutes | | Fluorouracil | 50.0 mg/ml
(50,000 ppm) | No breakthrough up to
240 minutes | |
| | Etoposide
(Toposar) | 20.0 mg/ml
(20,000 ppm) | >240 minutes | | Paclitaxel (Taxol) | 6.0 mg/ml
(6,000 ppm) | No breakthrough up to
240 minutes | |
| | Fluorouracil | 50.0 mg/ml
(50,000 ppm) | >240 minutes | | Cisplatin | 1.0 mg/ml
(1,000 ppm) | No breakthrough up to
240 minutes | |
| | Methotrexate | 25 mg/ml
(25,000 ppm) | >240 minutes | | Dacarbazine | 10.0 mg/ml
(10,000 ppm) | No breakthrough up to
240 minutes | |
| | Mitomycin C | 0.5 mg/ml (500 ppm) | >240 minutes | | Methotrexate | 25 mg/ml
(25,000 ppm) | No breakthrough up to
240 minutes | |
| | Paclitaxel (Taxol) | 6.0 mg/ml
(6,000 ppm) | >240 minutes | | Carmustine | 3.3 mg/ml
(3,300 ppm) | Not for use with
Camustine | |
| | Thio Tepa | 10.0 mg/ml
(10,000 ppm) | 27.4 minutes | | ThioTepa | 10.0 mg/ml
(10,000 ppm) | Not for use with
Thiotepa | |
| | Vincristine Sulfate
(Oncovin) | 1.0 mg/ml
(1,000 ppm) | >240 minutes | | | | | |
| | Do Not Use with Carmustine or Thiotepa | | | | | | | |
Summary of Non-Clinical Testing
The biocompatibility evaluation for the Medline Nitrile Powder Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs) was conducted in accordance with ANSVAAMI/ISO 10993- 1:2018 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA.
The following tests were performed to evaluate the biocompatibility of the Medline Nitrile Powder Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs)
- · ISO 10993-10: Primary Skin Irritation
- · ISO 10993-10: Dermal Sensitization
- · ISO 10993-05: Cytotoxicity
- · ISO 10993-11: Systemic Toxicity
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 2013), 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.
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To summarize, the performance testing of the subject device were conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
ASTM D 6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D 6124-06 (Reaffirmation 2017) Standard Test Method for Residual Powder on Medical Gloves ASTM D 5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves ASTM D 6978-05 (Reapproved 2013) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
Conclusion
In accordance with 21 CFR part 807, and based on the non-clinical testing and information provided in this premarket notification Medline Industries, Inc. concludes that the Medline Nitrile Powder Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicated device, Medline Powder Free Blue Nitrile Examination Glove (Tested for use with Chemotherapy Drugs) K051378.