(83 days)
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No
The device is a disposable examination glove, and the summary focuses on its barrier properties and testing against chemotherapy drugs. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device, Medline Glide-On 3G Vinyl Examination Gloves, is intended to prevent contamination between patients and examiners and has been tested for use with chemotherapy drugs, but it does not directly treat or diagnose a disease or condition.
No
Explanation: The device is described as disposable examination gloves intended to prevent contamination, not to diagnose medical conditions.
No
The device is described as disposable gloves, which are a physical product, 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 to prevent contamination between the patient and examiner by being worn on the hands or fingers. This is a barrier function for personal protection and infection control.
- No mention of in vitro testing: The description and performance studies focus on the glove's ability to resist permeation by chemotherapy drugs, which is a physical barrier property. There is no indication that the device is used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Anatomical Site: The anatomical site is the hands or fingers, which are external to the body and not related to collecting or analyzing biological samples.
IVD devices are used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs) are a disposable device intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between the patient and examiner.
The gloves were 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 | Minimum Breakthrough Detection |
|---|---|---|
| Carmustine | 3.3 mg/ml | 11.4 minutes |
| Cisplatin | 1.0 mg/ml | >240 minutes |
| Cyclophosphamide | 20.0 mg/ml | >240 minutes |
| Dacarbazine | 10.0 mg/ml | >240 minutes |
| Doxorubicin Hydrocholoride | 2.0 mg/ml | >240 minutes |
| Etoposide (Toposar) | 20.0 mg/ml | >240 minutes |
| Fluorouracil | 50.0 mg/ml | >240 minutes |
| Methotrexate | 25.0 mg/ml | >240 minutes |
| Paclitaxel (Taxol) | 6.0 mg/ml | >240 minutes |
| Thiotepa | 10.0 mg/ml | 17.4 minutes |
WARNING: DO NOT USE WITH CARMUSTINE DO NOT USE WITH THIOTEPA
Product codes
LZA, OPJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical purposes
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Key results are listed in the table under Indications for Use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and 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.
October 26, 2020
Medline Industries, Inc. Adam Ostrower Regulatory Affairs Sr. Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K202179
Trade/Device Name: Medline Glide-On 3G Vinyl 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, OPJ Dated: August 3. 2020 Received: August 4, 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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs)
Indications for Use (Describe)
The Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs) are a disposable device intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between the patient and examiner.
The gloves were 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 | Minimum Breakthrough Detection |
|---|---|---|
| Carmustine | 3.3 mg/ml | 11.4 minutes |
| Cisplatin | 1.0 mg/ml | >240 minutes |
| Cyclophosphamide | 20.0 mg/ml | >240 minutes |
| Dacarbazine | 10.0 mg/ml | >240 minutes |
| Doxorubicin Hydrocholoride | 2.0 mg/ml | >240 minutes |
| Etoposide (Toposar) | 20.0 mg/ml | >240 minutes |
| Fluorouracil | 50.0 mg/ml | >240 minutes |
| Methotrexate | 25.0 mg/ml | >240 minutes |
| Paclitaxel (Taxol) | 6.0 mg/ml | >240 minutes |
| Thiotepa | 10.0 mg/ml | 17.4 minutes |
WARNING: DO NOT USE WITH CARMUSTINE DO NOT USE WITH THIOTEPA
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------ |
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