A powder-free 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. In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Description

The Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs) are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free and are made of nitrile with a blue colorant. The gloves are offered non-sterile and are available in small, medium, large and extra-large sizes.

Permeation testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. The subject device was tested according to ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times were determined for a wide range of chemotherapy agents.

AI/ML Overview

This document is a 510(k) premarket notification for Medline Powder-Free Blue Nitrile Exam Gloves, Extended Cuff, which have been tested for use with chemotherapy drugs. It is a submission to the FDA seeking to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly refers to acceptance criteria by stating "Complies with ASTM D6319-10" or by providing specific thresholds. The "reported device performance" is implicitly shown by the claim of compliance or the listed breakthrough times.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Physical Properties (per ASTM D6319-10)
Dimension - Length	270mm min.	Complies with ASTM D6319-10 (270mm min.)
Dimension - Width	Small - 80 ±10mm min. Medium - 95 ±10mm min. Large - 110±10mm min. Extra-Large - 120±10mm min.	Complies with ASTM D6319-10 (Small - 80 ±10mm min., Medium - 95 ±10mm min., Large - 110±10mm min., Extra-Large 120±10mm min.) Note: Predicate device had slightly different width ranges (e.g., 85 ±5mm), but the proposed device still falls within acceptable ranges per ASTM D6319-10.
Dimension - Thickness	Palm - 0.10mm min. Finger - 0.10mm min.	Complies with ASTM D6319-10 (Palm - 0.10mm min., Finger - 0.10mm min.)
Tensile Strength	Before Aging - 14 MPa, min. After Aging - 14 MPa, min.	Complies with ASTM D6319-10 (Before Aging - 14 MPa, min., After Aging - 14 MPa, min.)
Elongation	Before Aging – 500% min. After Aging - 400% min.	Complies with ASTM D6319-10 (Before Aging – 500% min., After Aging - 400% min.)
Freedom from Holes	AQL 1.5 Inspection level G-2	Meets ASTM D6319-10 (AQL 1.5 Inspection level G-2)
Residual Powder	< 2.0 mg	Complies with ASTM D6319-10 (< 2.0 mg)
Biocompatibility (per ISO 10993-10)
Primary Skin Irritation	Not an irritant	Under the conditions of the test, not an irritant (ISO 10993-10:2010/(R) 2014)
Closed Patch Sensitization	Not a skin sensitizer	Under the conditions of the test, not a skin sensitizer (ISO 10993-10:2010/(R) 2014)
Chemotherapy Drug Permeation (per ASTM D6978-05)	Specific breakthrough times for various drugs
Carmustine 3.3mg/ml	-	40.4 min.
Cisplatin 1.0mg/ml	-	No breakthrough up to 240 min.
Cyclophosphamide 20.0mg/ml	-	No breakthrough up to 240 min.
Dacarbazine 2.0mg/ml	-	No breakthrough up to 240 min.
Doxorubicin HCl 2.0mg/ml	-	No breakthrough up to 240 min.
Etoposide 20.0mg/ml	-	No breakthrough up to 240 min.
Fluorouracil 50mg/ml	-	No breakthrough up to 240 min.
Methotrexate 25mg/ml	-	No breakthrough up to 240 min.
Mitoxantrone 2.0mg/ml	-	No breakthrough up to 240 min.
Paclitaxel 5.0mg/ml	-	No breakthrough up to 240 min.
Thiotepa 10mg/ml	-	60.6 min.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each physical, biocompatibility, or permeation test. It only refers to compliance with specific ASTM and ISO standards (e.g., ASTM D6319, ASTM D6978, ISO 10993-10). These standards typically define the sampling plans required for testing.

Data Provenance: The studies were non-clinical bench testing. The origin of the data is from Medline Industries, Inc. (the submitter). The document does not specify the country of origin for the actual testing or if it was retrospective or prospective, but it implies prospective testing conducted to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. This is a non-clinical device (medical glove) and the testing involves objective measurement against performance standards (ASTM, ISO), not subjective interpretation by human experts to establish ground truth.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving reader agreement on subjective assessments. This device underwent bench testing against objective criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is designed for evaluating diagnostic devices where human readers interpret medical images or data, often with and without AI assistance. This document describes the safety and performance testing of a physical medical device (gloves), not a diagnostic algorithm.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No. This concept is not applicable to a physical medical device like an examination glove. "Standalone performance" refers to the accuracy of an algorithm without human intervention, which is pertinent to AI/ML software as a medical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of these gloves is defined by the objective performance specifications outlined in recognized international standards:

Physical properties: ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application). The "ground truth" is that a glove either meets the specified tensile strength, elongation, dimensions, AQL for pinholes, etc., or it does not.
Biocompatibility: ISO 10993-10:2010/(R) 2014 (Biological Evaluation of Medical Devices – Part 10: Tests for irritation and skin sensitization). The "ground truth" is whether the device causes irritation or sensitization based on established biological test methods.
Chemotherapy Drug Permeation: ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs). The "ground truth" is the measured breakthrough time of the specific chemotherapy drugs, as determined by the standardized test method.

8. The Sample Size for the Training Set

N/A. The concept of a "training set" applies to machine learning algorithms. This document describes the testing of a physical medical device, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

N/A. As there is no training set for a physical product like a glove, this question is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 19, 2016

Medline, Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist One Medline Place Mundelein, Illinois 60060

Re: K161473

Trade/Device Name: Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: September 14, 2016 Received: September 16, 2016

Dear Jennifer Mason:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161473

Device Name

Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs)

Indications for Use (Describe)

The following chemicals have been tested with these gloves.

Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes

Carmustine 3.3mg/ml - 40.4 min. Cisplatin 1.0mg/ml - No breakthrough up to 240 min. Cyclophosphamide 20.0mg.ml - No breakthrough up to 240 min. Dacarbazine 2.0mg/ml - No breakthrough up to 240 min. Doxorubicin Hydrochloride 2/0mg.ml - No breakthrough up to 240 min. Etoposide 20.0mg/ml - No breakthrough up to 240 min. Fluoruouracil 50mg/ml - No breakthrough up to 240 min. Methotrexate 25mg - No breakthrough up to 240 min. Mitoxantrone 2.0mg/ml - No breakthrough up to 240 min. Paclitaxel 5.0mg/ml - No breakthrough up to 240 min. Thiotepa 10mg/ml - 60.6 min.

Please note that the following drugs have extremely low permeation times: Carmustine (3.3 mg/ml) has a minimum breakthrough time of 40.4 minutes; Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 60.6 minutes.

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 features the Medline logo, set against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized star or cross symbol. The symbol is white, contrasting with the blue background, and appears to be composed of four elongated triangles converging at a central point. A small gray rectangle is visible in the upper right corner of the image.

Aedline Industries, Inc. One Medline Place Mundelein, IL 60060

K161473 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]

Submitter / 510(k) Sponsor

Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060

Registration Number: 1417592

Contact Person

Jennifer Mason Senior Regulatory Affairs Specialist Phone: 847-643-3652 Email: JAMason@medline.com

Summary Preparation Date September 14, 2016

Type of 510(k) Submission Traditional

Device Name / Classification

Name of Device: Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs) Proprietary Name: Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs) Common Name: Patient Examination Glove Classification Name: Patient Examination Glove Product Code: LZA, LZC Classification Panel: General Hospital Regulatory Class: I Regulation #: 21 CFR 880.6250

Predicate Device

EMG Blue Nitrile Examination Gloves Powder Free with Tested for Use with Chemotherapy Drugs K141623

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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is in white, bold, sans-serif font, and to the right of the word is a white starburst symbol. There is a gray bar on the right side of the image.

ledline Industries, Inc. One Medline Place Mundelein, IL 60060

Device Description

Indications for Use

Chemotherapy Drugs	Breakthrough Times
Carmustine 3.3mg/ml	40.4 min.
Cisplatin 1.0mg/ml	No breakthrough up to 240 min.
Cyclophosphamide 20.0mg/ml	No breakthrough up to 240 min.
Dacarbazine 2.0mg/ml	No breakthrough up to 240 min.
Doxorubicin Hydrochloride 2.0mg/ml	No breakthrough up to 240 min.
Etoposide 20.0mg/ml	No breakthrough up to 240 min.
Fluorouracil 50mg/ml	No breakthrough up to 240 min.
Methotrexate 25mg/ml	No breakthrough up to 240 min.
Mitoxantrone, 2.0mg/ml	No breakthrough up to 240 min.
Paclitaxel 5.0mg/ml	No breakthrough up to 240 min.
Thiotepa 10mg/ml	60.6 min.

The following chemicals have been tested with these gloves

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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with a stylized white starburst symbol to the right of the text. The background is a solid dark blue color. The logo is simple and modern, and the colors are clean and professional.

Medline Industries, Inc. One Medline Place Mundelein, IL 60060

Summary of Technological Characteristics

TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES

Device Characteristic	Proposed Device	Predicate Device	ComparisonAnalysis
Product Name	Medline Powder-Free BlueNitrile Exam Glove ExtendedCuff (Tested for Use withChemotherapy Drugs)	EMG Blue NitrileExamination Gloves PowderFree with tested for use withchemotherapy drugs	Different
510(k) Reference	K161473	K141623	N/A
Product Owner	Medline Industries, Inc.	Eco Medi Glove SDN BHD	Different
Product Code	LZA, LZC	LZA, LZC	Same
Intended Use	A powder-free patientexamination glove is adisposable device intended formedical purposes that is wornon the examiner's hand orfinger to preventcontamination between patientand examiner and for use withchemotherapy drugs. Inaddition these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 Standard Practicefor Assessment of MedicalGlove to Permeation byChemotherapy Drugs.	A powder-free patientexamination glove is adisposable device intended formedical purposes that is wornon the examiner's hand orfinger to preventcontamination between patientand examiner and for use withchemotherapy drugs. Inadditional these gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 standards Practicefor assessment of MedicalGlove to Permeation byChemotherapy drugs.	Same
Regulation Number	21 CFR 880.6250	21 CFR 880.6250	Same
Materials	Nitrile	Nitrile	Same
Color	Blue	Blue	Same
Design Configurations	SmallMediumLargeExtra-Large	SmallMediumLargeExtra-Large	Same
Dimensions - Length	Complies with ASTM D6319-10270mm min.	Complies with ASTM D6319-10270mm min.	Same
Dimensions - Width	Complies with ASTM D6319-10Small - 80 ±10mm min.Medium - 95 ±10mm min.	Complies with ASTM D6319-10Small - 85 ±5mm min.Medium - 95 ±5mm min.	Same

	Large - 110±10mm min.	Large - 105±5mm min.
	Extra-Large 120±10mm min.	Extra-Large 115±5mm min.
Dimensions - Thickness	Complies with ASTM D6319-10	Complies with ASTM D6319-10	Same
	Palm - 0.10mm min.	Palm - 0.10mm min.
	Finger - 0.10mm min.	Finger - 0.10mm min.
Physical Properties -Tensile	Complies with ASTM D6319-10	Complies with ASTM D6319-10	Same
	Before Aging - 14 MPa, min.	Before Aging - 14 MPa, min.
	After Aging - 14 MPa, min.	After Aging - 14 MPa, min.
Physical Properties -Elongation	Complies with ASTM D6319-10	Complies with ASTM D6319-10	Same
	Before Aging – 500% min.	Before Aging – 500%
	After Aging - 400% min.	After Aging - 400%
Freedom from Holes	AQL 1.5 Inspection level G-2Meets ASTM D6319-10	AQL 2.5 Inspection level G-1Meets ASTM D6319-00a	Similar
Residual Powder	Complies with ASTM D6319-10 < 2.0 mg	Complies with ASTM D6319-00a <2.0 mg	Same
Biocompatibility	ISO 10993-10:2010/(R) 2014Under the conditions of thetest, not an irritant	Under the conditions of thetest, not an irritant	Same
	ISO 10993-10:2010/(R) 2014Under the conditions of thetest, not a skin sensitizer	Under the conditions of thetest, not a skin sensitizer
Prescription vs. OTC	OTC	OTC	Same
Sterile vs. Non-Sterile	Non-Sterile	Non-Sterile	Same
Single Use vs. Reusable	Single use	Single use	Same
Tested for Use withChemotherapy Drugs	Yes ASTM 6978-05	Yes ASTM D6978-05	Same
Chemotherapy DrugsTested	Carmustine 3.3mg/mlCisplatin 1.0mg/ml	Carmustine 3.3mg/ml	Similar
	Cyclophosphamide 20.0mg/mlDacarbazine 2.0mg/ml	Cyclophosphamide 20.0mg/ml
	Doxorubicin Hydrochloride2mg/ml	Doxorubicin Hydrochloride2mg/ml
	Etoposide 20.0mg.ml	Etoposide 20.0mg.ml
	Fluorouracil 50 mg/mlMethotrexate 25mg/mlMitoxantrone 2.0mg/ml	Fluorouracil 50 mg/mlMethotrexate 25mg/ml
	Paclitaxel 5.0mg/mlThiotepa 10mg/ml	Paclitaxel 5.0mg/mlThiotepa 10mg/ml
		Cytarabine 100mg.ml

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Image /page/6/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized starburst symbol. The starburst is white and appears to be composed of four elongated triangles converging at a central point. The overall design is clean and corporate, suggesting a professional and established brand identity.

Medline Industries, Inc. One Medline Place Mundelein, IL 60060

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Image /page/7/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized star-like symbol. The star is white and has four points, with the bottom point extending further down than the others. The background is a solid dark blue color, providing a strong contrast to the white text and symbol.

Medline Industries, Inc. One Medline Place Mundelein, IL 60060

Summary of Non-Clinical Testing

The biocompatibility evaluation for the Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs) was conducted in accordance with ANSVAAMI/ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. The Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs) is classified as a surface contacting device with a limited contact duration of less than 24 hours.

The following tests were performed to evaluate the biocompatibility of the Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs):

ISO 10993-10: Primary Skin Irritation Test ●
ISO 10993-10: Closed Patch Sensitization Test

Performance Testing (Bench)

Physical performance qualities were evaluated per ASTM D6319, 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. The gloves were tested according to ASTM D6978, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Minimum breakthrough times were determined for a wide range of chemotherapy drugs.

Summary of Clinical Testing

Not applicable.

Conclusion

Based on the non-clinical performance testing Medline Industries, Inc. concludes that the Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs) are as safe, as effective, and perform as well as the predicate device, EMG Blue Nitrile Medical Examination Gloves Powder Free with Tested for Use with Chemotherapy Drugs Labeling Claim (K141623). Therefore, the Medline Powder-Free Blue Nitrile Exam Glove, Extended Cuff (Tested for Use with Chemotherapy Drugs) are substantially equivalent to the predicate.

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.