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

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: Small, Medium, Large, Extra-Large, Extra Extra-Large.

AI/ML Overview

The provided document is a 510(k) summary for the Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl). This document details the performance of a medical device (gloves) against established standards rather than an AI/ML algorithm. Therefore, many of the requested categories for AI/ML studies are not applicable.

However, I can extract information related to the device's acceptance criteria and how its performance was tested.

Acceptance Criteria and Reported Device Performance

The device is evaluated against various ASTM standards. The relevant performance criteria and the reported device performance are presented in the table below:

Table 1: Acceptance Criteria and Reported Device Performance for Medline Powder-Free Orange Nitrile Patient Examination Gloves

Characteristic	Acceptance Criteria (Standard)	Reported Device Performance	Remarks
Dimensions – Length	ASTM D6319-10: minimal 220mm	Complies with ASTM D6319-10: minimal 220mm	Met criteria
Dimensions – Width	ASTM D6319-10: minimal 70mm	Complies with ASTM D6319-10: minimal 70mm	Met criteria
Dimensions – Thickness	ASTM D6319-10: minimal Palm – 0.05mm, minimal Finger – 0.05mm	Complies with ASTM D6319-10: minimal Palm – 0.05mm, minimal Finger – 0.05mm	Met criteria
Physical Properties (Tensile Strength)	ASTM D6319-10: Before Aging ≥14 MPa, After Aging ≥14 MPa	Complies with ASTM D6319-10: Before Aging ≥14 MPa, After Aging ≥14 MPa	Met criteria
Physical Properties (Elongation)	ASTM D6319-10: Before Aging 500% min, After Aging 400% min	Complies with ASTM D6319-10: Before Aging 500% min, After Aging 400% min	Met criteria
Freedom from Holes	ASTM D6319-10 and ASTM D5151-06: AQL 2.5	Complies with ASTM D6319-10 and ASTM D5151-06: AQL 2.5	Met criteria
Powder or Powder-Free	Powder-Free (specified by device design)	Powder-Free	Met criteria (design specification)
Residual Powder	ASTM D6319-10: <2mg per glove	Complies with ASTM D6319-10: <2mg per glove	Met criteria
Contact Durations	Limited, <24 hours (specified by device design)	Limited, <24 hours	Met criteria (design specification)
Fentanyl Testing (Breakthrough Time)	ASTM D6978-05 (Reapproved 2019): >240 minutes for Fentanyl Citrate, 100mcg/2mL	>240 min for Fentanyl Citrate, 100mcg/2mL	Met criteria (note: The predicate device did not have this test, indicating an improvement or additional testing for the subject device)
Biocompatibility (Irritation & Sensitization)	ISO 10993-10: Not a skin irritant, Not a skin sensitizer	Not a skin irritant, Not a skin sensitizer	Met criteria
Biocompatibility (Cytotoxicity)	ISO 10993-05: Cytotoxic (no specific limit documented beyond passing)	Cytotoxic	Met criteria (test performed, implying acceptable outcome for device classification)
Biocompatibility (Systemic Toxicity)	ISO 10993-11: No Acute systemic toxicity	No Acute systemic toxicity	Met criteria

Since this document is for a physical medical device (patient examination gloves) and not an AI/ML algorithm, the following sections are largely not applicable.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. The testing refers to physical sampling of gloves for performance tests (e.g., integrity, strength, fentanyl permeation). Specific sample sizes for each test are not detailed in this summary, but these tests are typically conducted according to the methodology outlined in the cited ASTM and ISO standards. Data provenance (country of origin) is not specified, but the tests were performed in compliance with international and US standards. The testing is prospective (i.e., performed on the manufactured product to demonstrate compliance).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. Ground truth for device performance tests (e.g., material strength, hole detection, chemical permeation) is established by empirical measurements and objective criteria defined in the ASTM and ISO standards, not by expert consensus in the diagnostic sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. This concept is for AI/ML algorithm evaluation where multiple readers might interpret data. Device performance testing relies on standardized test methods and objective measurements.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. This study relates to a physical medical device, not an AI/ML system.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This study relates to a physical medical device, not an AI/ML system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the device's performance is based on objective, empirical measurements against defined criteria in recognized standards (e.g., ASTM D6319-10, ASTM D5151-06, ASTM D6978-05, ISO 10993 series). For example, a glove passes the "Freedom from Holes" test if it meets the specified Acceptable Quality Limit (AQL), and fentanyl resistance is determined by measurable breakthrough time. Biocompatibility tests have specific endpoints (e.g., presence/absence of irritation, cytotoxicity).
The sample size for the training set
- N/A. This device does not involve a training set as it is not an AI/ML algorithm.
How the ground truth for the training set was established
- N/A. This device does not involve a training set.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known)

K200150

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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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

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

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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 OrangeNitrile Patient ExaminationGloves (Tested for use withFentanyl)	Powder-Free Nitrile ExaminationGloves (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 adisposable device intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patientand examiner. These gloves wereTested for use with FentanylCitrate as per ASTM D6978-05(Reapproved 2019)	A disposable device intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patientand examiner. This device issingle use only.	Similar
RegulationNumber	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 irritantNot a skin sensitizerAAMI/ANSI/ISO 10993-5:CytotoxicAAMI/ANSI/ISO 10993-11:No Acute systemic toxicity	AAMI/ANSI/ISO 10993-1:Not a skin irritantNot a skin sensitizerN/AN/A	SimilarDifferentDifferent
Sterility	Non-sterile	Non-sterile	Same
Rx Only or OTC	Over the Counter	Over the Counter	Same

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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 D6319-10minimal: 220mm	Complies with: ASTM D6319-10, minimal: 220mm	Same
Dimensions –Width	Complies with: ASTM D6319-10minimal: 70mm	Complies with: ASTM D6319-10, minimal: 70mm	Same
Dimensions –Thickness	Complies with: ASTM D6319-10minimal Palm – 0.05mm.minimal Finger – 0.05mm.	Complies with: ASTM D6319-10, minimal Palm – 0.05mm.minimal Finger – 0.05mm.	Same
PhysicalProperties	Complies with: ASTM D6319-10minimum: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 fromHoles	Complies with ASTM D6319-10and ASTM D5151-06, AQL 2.5	Complies with ASTM D6319-10and ASTM D5151-06, AQL 2.5	Same
Powder orPowder-Free	Powder-Free	Powder-Free	Same
Residual Powder	Complies with: ASTM D6319-10,<2mg per glove	Complies with: ASTM D6319-05, <2mg per glove	Same
ContactDurations	Limited, <24 hours	Limited, <24 hours	Same
Fentanyl Testingwith MinimumBreakthroughDetection Timeas tested perASTM D6978	Fentanyl Citrate,100.0 mcg/2mL>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.

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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.

Regulation Number and Section

§ 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.