(160 days)
A 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.
The proposed device is a disposable device intended for over the counter use. It is not made with natural rubber latex. Instead, the gloves are formulated using vinyl synthetic polymer. The glove is coated with an emollient coating. The gloves are manufactured using molds that are ambidextrous. They are offered powder-free and non-sterile.
The provided document describes the acceptance criteria and performance data for the Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu-Thera® Coating. This is a medical device application for examination gloves, and therefore the "device" in this context refers to these gloves.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and the Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Primary Skin Irritation | Non-irritating (per ISO 10993-10) | Non-irritating |
| Guinea Pig Maximization | Non-sensitizing (per ISO 10993-10) | Non-sensitizing |
| Physical Characteristics | ||
| Dimensions | Meets ASTM D5250 requirements | Meets requirements |
| Physical Properties | Meets ASTM D5250 requirements for vinyl examination gloves | Meets requirements |
| Freedom from Holes | Meets 21 CFR 800.20 & ASTM D5250 requirements of AQL 2.5 | Tested in accordance with ASTM D 5151 with acceptable results; Meets requirements of AQL 2.5 |
| Powder Residual | Meets requirements of ≤2.0 mg/glove for "Powder-Free" designation per ASTM D5250 | Gloves meet powder level requirements for "Powder-Free" designation per ASTM D5250. Results generated values < 2mg of residual powder per glove. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size for each specific test mentioned (e.g., how many gloves were tested for freedom from holes or powder residual). It refers to compliance with ISO and ASTM standards, which would define appropriate sample sizes for these types of tests.
The data provenance is from non-clinical tests conducted by Cardinal Health, Inc. This is prospective testing performed on the device itself. There is no information regarding country of origin for the data beyond being submitted by a US-based company for FDA approval in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable in this context. The "ground truth" for a medical device like examination gloves is typically established through adherence to recognized international and national consensus standards (like ISO and ASTM) and regulatory requirements (like 21 CFR). These standards define objective, measurable performance criteria. Expert judgment, while informing the development of such standards, is not directly applied on a case-by-case basis to "establish ground truth" for individual glove performance during testing in the way it would be for, say, image interpretation in AI.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used when there's subjective interpretation involved, such as in clinical trials or when establishing ground truth from multiple expert readings. For objective physical and chemical tests of a medical device like gloves, the results are derived directly from the test methods and interpreted against the defined criteria in the standards.
5. 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
This is not applicable. An MRMC comparative effectiveness study is relevant for AI-powered diagnostic devices or tools that assist human interpreters (e.g., radiologists interpreting images). The device in question is an examination glove, which does not involve human "readers" or AI assistance in this manner.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This question pertains to AI/algorithm performance. The device is a physical product (gloves) and does not involve any algorithms.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on accepted international and national consensus standards and regulatory requirements. Specifically:
- Biocompatibility: ISO 10993-10 standards.
- Physical Characteristics (Dimensions, Physical Properties, Freedom from Holes, Powder Residual): ASTM D5250, ASTM D5151, ASTM D6124, and 21 CFR 800.20.
These standards define the objective performance benchmarks that the gloves must meet.
8. The Sample Size for the Training Set
This is not applicable. This question refers to the training of an AI model. The device (examination gloves) does not utilize a training set in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
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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 emblem featuring a stylized depiction of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2016
Cardinal Health, Inc. Megan Middaugh Manager, Regulatory Affairs 1500 Waukegan Road Waukegan, IL 60085
Re: K160411
Trade/Device Name: Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu-Thera® Coating (Esteem® Synthetic with Neu-Thera®) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 13, 2016 Received: June 14, 2016
Dear Ms. Middaugh:
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
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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 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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) K160411
Device Name
Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu- thera® Coating (Esteem® Synthetic with Neu-Thera®)
Indications for Use (Describe)
A 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.
| 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 shows the logo for Cardinal Health. The logo consists of a stylized red bird-like design above the company name. The company name "CardinalHealth" is written in a bold, sans-serif font, with "Cardinal" in black and "Health" in a slightly darker shade of black.
Cardinal Health 1500 Waukegan Road Waukegan, IL 60085 cardinalhealth.com
Page 1 of 5
510(k) SUMMARY
Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu-thera® Coating (Esteem® Synthetic with Neu-Thera®)
| Manufacturer: | Cardinal Health 200, LLC1500 Waukegan RoadWaukegan, IL 60085 |
|---|---|
| Regulatory Affairs Contact: | Megan Middaugh1500 Waukegan RoadWaukegan, IL 60085 |
| Telephone Number: | (847) 887-6812 |
| Fax Number: | (847) 887-2461 |
| Date Summary Prepared: | July 14, 2016 |
| Product Trade Name: | Cardinal Health™ Vinyl Powder-Free Exam Gloves with NeuThera® Coating (Esteem® Synthetic with Neu-Thera®) |
| Common Name: | Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Classification Panel: | General Hospital and Personal Use Devices |
| Regulation: | 21 CFR 880.6250 |
| Product Code: | LYZ |
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Image /page/4/Picture/1 description: The image shows the Cardinal Health logo. The logo consists of a stylized red graphic above the company name. The graphic is composed of several curved lines that resemble a bird in flight. The company name, "CardinalHealth," is written in a bold, sans-serif font, with "Cardinal" in regular weight and "Health" in bold.
510(K) SUMMARY (CONT'D)
| Predicate Devices: | K052568 - Cardinal Health's Esteem Stretchy Synthetic with Neu-Thera® Powder-Free Exam Gloves |
|---|---|
| Reason for 510(k) Submission: | Modification of a legally marketed device |
| Device Description: | The proposed device is a disposable device intended for over the counter use. It is not made with natural rubber latex. Instead, the gloves are formulated using vinyl synthetic polymer. The glove is coated with an emollient coating. The gloves are manufactured using molds that are ambidextrous. They are offered powder-free and non-sterile. |
| Intended Use: | A 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. |
| Substantial Equivalence: | The proposed device is substantially equivalent to the predicate device identified in this 510(k) summary. Substantial equivalence can be established in regard to intended use, physical properties and characteristics, design and product features. Both gloves are made of synthetic vinyl using the same manufacturing process. |
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Table 1: Summary of Technological Characteristics
| Summary of the technological characteristics of the device compared to the predicate device | ||
|---|---|---|
| Characteristic | Subject Device | Predicate Device |
| MaterialComposition | Cardinal Health™ Vinyl Powder-FreeExam Gloves with Neu-Thera® Coating(Esteem® Synthetic with Neu-Thera®) | Cardinal Health's Esteem StretchySynthetic with Neu-Thera® Powder-Free Exam Gloves (K052568) |
| MaterialComposition | VinylCoated with emollient coating | VinylCoated with emollient coating |
| Design | AmbidextrousBeaded cuffLubricated | AmbidextrousBeaded cuffLubricated |
| Intended Use | A patient examination glove is adisposable device intended for medicalpurposes that is worn on the examiner'shand or finger to prevent contaminationbetween patient and examiner. | A patient examination glove is adisposable device intended for medicalpurposes that is worn on the examiner'shand or finger to prevent contaminationbetween patient and examiner. |
| Label Claims | Single Use OnlyNon-sterilePowder-freeNot made with natural rubber latexCoated with proprietary formulation | Single Use OnlyNon-sterilePowder-freeNot made with natural rubber latexCoated with proprietary formulation |
| Dimensions &PhysicalProperties | Meets ASTM D5250 | Meets ASTM D5250 |
| Freedom fromHoles | Meets 21CFR 800.20 & ASTM D5250requirements of AQL 2.5 | Meets 21CFR 800.20 & ASTM D5250requirements of AQL 2.5 |
| Powder Residual | Meets requirements of ≤2.0 mg/glove forPowder-Free designation per ASTMD5250 | Meets requirements of ≤2.0 mg/glovefor Powder-Free designation per ASTMD5250 |
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Table 2: Summary of Non-Clinical Tests
| PERFORMANCE DATA | ||
|---|---|---|
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION | ||
| OF SUBSTANTIAL EQUIVALENCEPerformance Test Summary-New Device | ||
| Characteristic | Standard/Test/FDAGuidance | Results Summary |
| Biocompatibility: | ||
| Primary SkinIrritation | ISO 10993-10 | Non-irritating |
| Guinea PigMaximization | ISO 10993-10 | Non-sensitizing |
| Physical Characteristics: | ||
| Dimensions | ASTM D5250 | Meets requirements |
| Physical Properties | ASTM D5250 | Meet requirements for vinyl examinationgloves |
| Freedom from Holes | 21 CFR 800.20 &ASTM D5250 | Tested in accordance with ASTM D 5151with acceptable results; Meetsrequirements of AQL 2.5 |
| Powder Residual | ASTM D5250 testedusing ASTMstandard D6124 | Gloves meet powder level requirements for"Powder-Free" designation per ASTMD5250. Results generated values < 2mg ofresidual powder per glove. |
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Table 3: Summary of Comparative Performance
| Comparative Performance Information Summary | |||
|---|---|---|---|
| Characteristic | Requirement | Subject Device | Predicate Device |
| Biocompatibility: | ISO 10993-1 | Cardinal Health™ VinylPowder-Free Exam Gloves withNeu-Thera® Coating (Esteem®Synthetic with Neu-Thera®) | Cardinal Health's EsteemStretchy Synthetic with Neu-Thera® Powder-Free ExamGloves (K052568) |
| Primary Skin Irritation | ISO 10993-10 | Non-irritating | Non-irritating |
| Guinea Pig Maximization | ISO 10993-10 | Non-sensitizing | Non-sensitizing |
| Dimensions | ASTM D5250 | Meets requirements | Meets requirements |
| Physical Properties | ASTM D5250 | Meets requirements | Meets requirements |
| Freedom from Holes | 21CFR800.20,ASTM D5250 | Meets requirements | Meets requirements |
| Powder Residual | ASTM D5250 | Meets requirements | Meets requirements |
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical data is not required.
CONCLUSIONS DRAWN FROM NON-CLINICAL DATA
Non-clinical data demonstrates Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu-Thera® Coating (Esteem® Synthetic with Neu-Thera®) meet the technological characteristics of ASTM D5250 standard, and are as safe, as effective, and performed as well as the legally marketed devices identified in this summary.
§ 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.