(130 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 devices, Powder-free Vinyl Exam Gloves are non-sterile, clear, noncolored and disposable medical gloves intended to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
The provided text describes a 510(k) premarket notification for "Clear Vinyl Powder-free Patient Examination Gloves" (K171317) by Shandong Zhi Hong Medical Products, Co. Ltd. This document is a regulatory submission for a Class I medical device (patient examination glove).
Based on the nature of the device (disposable examination gloves) and the content of the provided document, this submission does not involve an AI/ML-driven device, nor does it describe a study with AI/ML specific acceptance criteria, test sets, ground truth establishment, or human-in-the-loop performance evaluation.
The document focuses on demonstrating substantial equivalence to a predicate device (Powder-free PVC Vinyl Exam Gloves, K142703) through non-clinical performance tests for physical characteristics, material properties (like tensile strength, elongation), and biocompatibility (skin irritation, sensitization).
Therefore, I cannot provide the requested information regarding acceptance criteria and studies that prove an AI/ML device meets them, as this document pertains to a traditional, non-AI medical device.
To directly answer your prompt, based on the provided text, the following points apply:
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1. A table of acceptance criteria and the reported device performance: A table is provided (TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES) showing comparison points for physical and performance characteristics of the gloves (e.g., Length, Width, Thickness, Residual Powder, Pinhole Results, Biocompatibility, Tensile Strength, Ultimate Elongations). The "acceptance criteria" here are implicitly meeting or being similar to the predicate device's performance and relevant ASTM standards (ASTM-D-5250-06, ASTM D6124-06, ASTM D5151-06).
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2. Sample sizes used for the test set and the data provenance:
- Pinhole Results: "less than two pieces gloves out of 125 pieces gloves." This indicates a sample size of 125 pieces of gloves for pinhole testing.
- FDA 1000 ml. Water Fill Test: Sample size of "AQL 2.5, Inspection Level I". This is an industry standard sampling plan for quality control rather than a specific number of gloves.
- Other tests (Tensile Strength, Elongation, Residual Powder, Biocompatibility) do not explicitly state sample sizes in the provided text, beyond general statements like "samplings" or "testing result indicates."
- Data Provenance: The tests were conducted by the manufacturer, Shandong Zhi Hong Medical Products, Co. Ltd., in China. The data would be retrospective in the sense that it's reported from tests already performed.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these physical and chemical tests is established by standardized testing methods (ASTM standards) and laboratory measurements, not human expert consensus.
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4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is for assessing clinical interpretation, not physical product testing.
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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: Not applicable. This is not an AI/ML device.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the conducted tests is based on standardized laboratory measurements and chemical/physical test results as defined by ASTM standards for glove performance (e.g., direct measurement of length, thickness, tensile strength; water fill test to detect pinholes; chemical analysis for residual powder; in-vivo animal or human patch tests for biocompatibility).
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8. The sample size for the training set: Not applicable. This is a traditional device, not an AI/ML device requiring a training set.
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9. How the ground truth for the training set was established: Not applicable. This is a traditional device, not an AI/ML device.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2017
Shandong Zhi Hong Medical Products, Co. Ltd. % Melo Zhang Official Correspondent Intco Medical Industries, INC. 805 Barrington Ave Ontario, California 91764
Re: K171317
Trade/Device Name: Clear Vinyl Powder-free Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: August 21, 2017 Received: August 23, 2017
Dear Melo Zhang:
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 (DICE) 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 (DICE) 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, Tara A. Ryan -S 2017.09.11 19:39:48 -04'00' for Lori Wiggins, MPT, CLT 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) K171737
Device Name
Clear Vinyl Powder-free Patient Examination Gloves
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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/14)
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Shandong Zhi Hong Medical Products, Co. Ltd.
231 Dongqi Industrial Park Qingzhou City, Shandong China
510(K) SUMMARY
Submitter / 510(k) Sponsor
Shandong Zhi Hong Medical Products, Co. Ltd. 231 Dongqi Industrial Park Qingzhou City, Shandong China
Contact Person
Melo Zhang Official Correspondent Phone: 909 980 1678 Email: melozhang@intcous.com
Summary Preparation Date
Sept 5, 2017
Type of 510(k) Submission
Traditional
Device Name / Classification
Name of Device: Clear Vinyl Powder-free Patient Examination Gloves Proprietary Name: Powder-Free Vinyl Patient Examination Gloves Common Name: Vinyl Patient Examination Glove Classification Name: Patient Examination Glove Product Code: LYZ Product Class: Class I Regulation #: 21 CFR 880.6250 Classification Panel: General Hospital
Predicate Device
Powder-free PVC Vinyl Exam Gloves, Hebei Grandeast Plastic Products Co., Ltd. K142703
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Image /page/4/Picture/0 description: The image contains the logo and name of a company. The logo is on the left side of the image and appears to be a stylized graphic. To the right of the logo is the text "Shandong Zhi Hong Medical Products, Co. Ltd." The text is in a bold, serif font, and the company name is underlined.
231 Dongqi Industrial Park Qingzhou City, Shandong China
Device Description
The proposed devices, Powder-free Vinyl Exam Gloves are non-sterile, clear, noncolored and disposable medical gloves intended to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Non Clinical Performance Tests
Scientific concepts: The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level I, to prevent contamination between patient and examiner; Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
Significant physical and performance characteristics of the device: glove production is based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AOL 2.5.
Subject Clear Vinyl Powder-free Patient Examination Gloves do not contain any USP powder per the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirement of ASTM Standard D5250-06.
Overall Length: 230mm min Width: 94mm min Palm Thickness: 0.09 mm min Fingertip Thickness: 0.086 mm min Tensile Strength (Mpa) Before aging 15Mpa min After aging 13Mpa min Ultimate Elongations Before aging 495% min After aging 415% min
Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
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Shandong Zhi Hong Medical Products, Co. Ltd.
231 Donggi Industrial Park Qingzhou City, Shandong China
TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
| DeviceCharacteristics | Proposed Device | Predict Device(K142703) | ComparisonConclusion |
|---|---|---|---|
| Product Name | Shandong Zhi Hong MedicalProducts, Co. Ltd.Clear Vinyl Powder-freePatient Examination Gloves, | Hebei Grandeast PlasticProducts Co., Ltd.Glide-On VinylExamination Gloves | |
| Product Code | LYZ | LYZ | Similar |
| Intended Use | Disposable device intended formedical purposes that is wornon the examiner's hand orfinger to preventcontamination between patientand examiner | Disposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner | Similar |
| Length on LargeSize | Average over 232.23mm | Average over 230mm | Similar |
| Width of Palm onLarge Size | Average 95mm | Average 95mm | Similar |
| Palm Thickness | Average 0.095 mm | Average 0.095 mm | Similar |
| Fingertip Thickness | Average 0.09 mm | Average 0.09 mm | Similar |
| Residual Powder | According to ASTM D6124-06Standard Test Method forResidual Powder on Medicalgloves for the determination ofresidual powder content.Testing result indicates theweight of all types of residualor powder on finished powder-free gloves as < 2 mg per gloveand there is no defect glovefound according to ASTMD6124-06. | According to ASTMD6124-06 Standard TestMethod for ResidualPowder on Medicalgloves for thedetermination of residualpowder content. Testingresult indicates the weightof all types of residual orpowder on finishedpowder-free gloves as < 2mg per glove and there isno defect glove foundaccording to ASTMD6124-06. | Similar |
| Pinhole Results | According to ASTM D5151-06, Testing result indicatespinhole were found less than | According to ASTMD5151-06, Testing resultindicates pinhole werefound less than two pieces | Similar |
| two pieces gloves out of 125pieces gloves. AQL 2.5 is met. | gloves out of 125 piecesgloves. AQL 2.5 is met. | ||
| BiocompatibilityResult: PrimarySkin Irritation | Under the conditions of thestudy, the subject device is notan irritant | Under the conditions ofthe study, the subjectdevice is not an irritant | Similar |
| Before Aging:TensileStrength(Mpa) andUltimateElongations | Average Tensile Strength(Mpa): 16.96Average Ultimate Elongations:519% | Average Tensile Strength(Mpa): 16.96AverageUltimateElongations: 519% | Similar |
| After Aging:TensileStrength(Mpa) andUltimateElongations | Average Tensile Strength(Mpa): 14.92Average Ultimate Elongations:480% | Average Tensile Strength(Mpa): 14.92AverageUltimateElongations: 480% | Similar |
| DermalSensitization | Under the conditions of thestudy, the subject device is notan sensitizer | Under the conditions ofthe study, the subjectdevice is not an sensitizer | Similar |
| Summary | Shandong Zhi Hong Medical Products, Co. Ltd. Clear Vinyl Powder-freePatient Examination Gloves are Similar to the predicate, K142703. Both gloveshave the same intended use, same material and the same device performance. |
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Shandong Zhi Hong Medical Products, Co. Ltd.
231 Dongqi Industrial Park Qingzhou City, Shandong China
Conclusion
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the subject device is as safe, as effective, and performs as well as the predict device.
§ 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.