(278 days)
Not Found
No
The device description and performance studies focus on the physical properties and chemical resistance of the gloves, with no mention of AI or ML technology.
No.
The device (patient examination glove) is intended to prevent contamination between a patient and an examiner and provides protection against certain drugs, but it does not treat or cure a disease or medical condition.
No.
The device is a patient examination glove, intended to prevent contamination between a patient and examiner, and is not used to diagnose any medical condition.
No
The device described is a physical medical device (patient examination gloves) and does not involve any software component.
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 "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 used for protection during physical examination, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces the intended use as a protective glove for examiners.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect analytes, or provide diagnostic information. The testing mentioned (ASTM standards for gloves, fentanyl permeation, biocompatibility) relates to the physical properties, safety, and barrier function of the glove, not its ability to perform an in vitro diagnostic test.
In summary, the device is a medical glove used for barrier protection, which falls under a different regulatory classification than In Vitro Diagnostic devices.
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.
It has also been tested for use against Fentanyl Citrate, ASTM D6978-05 (Reapproved 2019, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs).
Drugs Tested: Fentanyl Citrate, 100mcg/2mL Breakthrough Time (Minutes) >240 min
Product codes
LZA, QDO
Device Description
The Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl) 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, powderfree, ambidextrous, and orange-colored with a beaded cuff. The proposed device is offered in in the following sizes:
TABLE 1: The Medline Powder-Free Orange Nitrile Patient Examination Gloves
| Model Number | Size |
|---|---|
| CR911S | Small |
| CR911M | Medium |
| CR911L | Large |
| CR911XL | Extra-Large |
| CR911XXL | Extra Extra-Large |
The subject 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 Fentanyl per ASTM D6978-05 (Reapproved 2019).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands (on the examiner)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner / Not Specified
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
The following performance testing was conducted to demonstrate the safety and effectiveness of the subject device in accordance with the relevant standards cited below:
- ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D6124-06 (Reaffirmation 2011) Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-06 (Reapproved 2011) Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
Biocompatibility evaluation:
The biocompatibility evaluation for the Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl) was conducted in accordance with ANSUAAMI/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:
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- ISO 10993-05:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-11: 2017 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity.
- ISO 10993-12: 2012 Biological Evaluation of Medical Devices, Part 12: Sample Preparation and Reference Materials.
Conclusion:
The conclusion drawn from the nonclinical tests demonstrates that the subject device, the Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl) are as safe, effective, and performs as well or better as the legally marketed predicate device cleared under K120890.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fentanyl Testing with Minimum Breakthrough Detection Time as tested per ASTM D6978: Fentanyl Citrate, 100.0 mcg/2mL Breakthrough Time >240 min
Physical Properties:
Tensile Strength: Before Aging >=14 MPa., After Aging >=14 MPa.
Elongation: Before Aging 500%, min., After Aging 400%, min.
Freedom from Holes: AQL 2.5
Residual Powder:
§ 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 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
October 26, 2020
Medline Industries Inc Leontyne Banks Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60061
Re: K200150
Trade/Device Name: Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, QDO Dated: September 23, 2020 Received: September 23, 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 (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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl)
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.
It has also been tested for use against Fentanyl Citrate, ASTM D6978-05 (Reapproved 2019, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs).
Drugs Tested: Fentanyl Citrate, 100mcg/2mL Breakthrough Time (Minutes) >240 min
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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3
510(K) SUMMARY
K200150
[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 October 18, 2020
Type of 510(k) Submission
Traditional
Device Name / Classification
Device Name: Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl)
Proprietary Name: Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl)
Common Name: Patient Examination Glove, Specialty
Classification Name: Polymer Patient Exam Glove. Fentanyl and other Opioid Protection Glove Product Code: LZA, QDO Classification Panel: General Hospital Regulation #: 21 CFR 880.6250
Predicate Device
Shen Wei (USA), Inc.: Powder-Free Nitrile Examination Gloves (Orange), K120890
Device Description
The Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl) 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, powderfree, ambidextrous, and orange-colored with a beaded cuff. The proposed device is offered in in the following sizes:
TABLE 1: The Medline Powder-Free Orange Nitrile Patient Examination Gloves
| Model Number | Size |
|---|---|
| CR911S | Small |
| CR911M | Medium |
| CR911L | Large |
| CR911XL | Extra-Large |
| CR911XXL | Extra Extra-Large |
4
The subject 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 Fentanyl per ASTM D6978-05 (Reapproved 2019).
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. It has also been tested for use against Fentanyl Citrate, ASTM D6978-05 (Reapproved 2019, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs).
Drugs Tested: Fentanyl Citrate, 100mcg/2mL Breakthrough Time (Minutes) >240
| Comparison of Technological Characteristics for the subject and Predicate Devices | ||||||
|---|---|---|---|---|---|---|
| Click ------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | (1---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | D D D D IZ100000 D D |
| Characteristic | Subject Device K200150 | Predicate Device K120890 | Remarks |
|---|---|---|---|
| Product Name | Medline Powder-Free Orange | ||
| Nitrile Patient Examination | |||
| Gloves (Tested for use with | |||
| Fentanyl) | Powder-Free Nitrile Examination | ||
| Gloves (Orange) | N/A | ||
| 510(k) Number | K200150 | K120890 | N/A |
| Manufacture | Medline Industries, Inc. | Shen Wei (USA), Inc | N/A |
| Product Code | LZA, QDO | 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 Fentanyl | |||
| Citrate as per ASTM D6978-05 | |||
| (Reapproved 2019) | A disposable device intended for | ||
| medical purposes that is worn on | |||
| the examiner's hand to prevent | |||
| contamination between patient | |||
| and examiner. This device is | |||
| single use only. | Similar | ||
| Regulation | |||
| Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Materials | Powder-Free Nitrile | Powder-Free Nitrile | Same |
| Color | Orange | Orange | Same |
| Sizes | Small, Medium, Large, X- large, | ||
| XX-large | Small, Medium, Large | Similar | |
| Biocompatibility | AAMI/ANSI/ISO 10993-10: | ||
| Not a skin irritant | |||
| Not a skin sensitizer | |||
| AAMI/ANSI/ISO 10993-5: | |||
| Cytotoxic | |||
| AAMI/ANSI/ISO 10993-11: | |||
| No Acute systemic toxicity | AAMI/ANSI/ISO 10993-1: | ||
| Not a skin irritant | |||
| Not a skin sensitizer | |||
| N/A | |||
| N/A | Similar | ||
| Different | |||
| Different | |||
| Sterility | Non-sterile | Non-sterile | Same |
| Rx Only or OTC | Over the Counter | Over the Counter | Same |
5
Summary of Non-Clinical Testing
The following performance testing was conducted to demonstrate the safety and effectiveness of the subject device in accordance with the relevant standards cited below:
· ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application
• ASTM D6124-06 (Reaffirmation 2011) Standard Test Method for Residual Powder on Medical Gloves
• ASTM D5151-06 (Reapproved 2011) Standard Test Method for Detection of Holes in Medical Gloves
· ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
| Characteristic | Subject Device K200150 | Predicate Device K120890 | Remarks |
|---|---|---|---|
| Dimensions – | |||
| Length | Complies with: ASTM D6319-10 | ||
| minimal: 220mm | Complies with: ASTM D6319- | ||
| 10, minimal: 220mm | Same | ||
| Dimensions – | |||
| Width | Complies with: ASTM D6319-10 | ||
| minimal: 70mm | Complies with: ASTM D6319- | ||
| 10, minimal: 70mm | Same | ||
| Dimensions – | |||
| Thickness | Complies with: ASTM D6319-10 | ||
| minimal Palm – 0.05mm. | |||
| minimal Finger – 0.05mm. | Complies with: ASTM D6319- | ||
| 10, minimal Palm – 0.05mm. | |||
| minimal Finger – 0.05mm. | Same | ||
| Physical | |||
| Properties | Complies with: ASTM D6319-10 | ||
| minimum: | |||
| Tensile Strength: | |||
| Before Aging ≥14 MPa. | |||
| After Aging ≥14 MPa. | |||
| Elongation: | |||
| Before Aging 500%, min. | |||
| After Aging 400%, min. | Complies with: ASTM D6319- | ||
| 10 minimum: | |||
| Tensile Strength: | |||
| Before Aging ≥14 MPa. | |||
| After Aging ≥14 MPa. | |||
| Elongation: | |||
| Before Aging 500% min. | |||
| After Aging 400% min. | Same | ||
| Freedom from | |||
| Holes | Complies with ASTM D6319-10 | ||
| and ASTM D5151-06, AQL 2.5 | Complies with ASTM D6319-10 | ||
| and ASTM D5151-06, AQL 2.5 | Same | ||
| Powder or | |||
| Powder-Free | Powder-Free | Powder-Free | Same |
| Residual Powder | Complies with: ASTM D6319-10, | ||
| 240 min | N/A | Different |
The biocompatibility evaluation for the Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl) was conducted in accordance with ANSUAAMI/ISO 10993-1:2018 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA.
6
The following tests were performed to evaluate the biocompatibility of the Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl):
- · ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- · ISO 10993-05:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-11: 2017 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity.
- ISO 10993-12: 2012 Biological Evaluation of Medical Devices, Part 12: Sample Preparation and Reference Materials.
Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device, the Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl) are as safe, effective, and performs as well or better as the legally marketed predicate device cleared under K120890.