A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.

Device Description

Subject device: Powder Free Clear Vinyl Patient Examination Glove Color: Clear Overall Length: 230mm min Width: 94mm min Palm Thickness: 0.09 mm min Fingertip Thickness: 0.086 mm min

AI/ML Overview

The provided document describes the acceptance criteria and performance of the Powder-Free Clear Vinyl Patient Examination Gloves by Zibo Yue Fan Medical Products Co., Ltd. against a predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are defined by compliance with ASTM standards and key physical properties. The "reported device performance" reflects the measured values for the subject device and the predicate device.

Device Characteristics / Acceptance Criteria	Proposed Device (Reported Performance)	Predicate Device (Reported Performance)	Comparison Conclusion
Product Name	Powder Free Clear Vinyl Patient Examination Glove	Powder free PVC Vinyl Exam Gloves
Product Code	LYZ	LYZ	Same
Intended Use (Disposable device for medical purposes, worn on examiner's hand/finger to prevent contamination)	Disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.	Disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.	Same
Regulation Number (21 CFR 880.6250)	21 CFR 880.6250	21 CFR 880.6250	Same
Sizes	Small, Medium, Large, Extra-Large	Small, Medium, Large, Extra-Large	Same
Length on Large Size (ASTM-D-5250-06 requirement: 230mm min)	Average over 232.23mm (Meets)	Average over 230mm (Meets)	Similar
Width of Palm on Large Size (ASTM-D-5250-06 general requirement for width for size Large: 94mm min, see page 4 for subject device spec)	Average 95mm (Meets)	Average 95mm (Meets)	Similar
Palm Thickness (ASTM-D-5250-06 general requirement: 0.09 mm min, see page 4 for subject device spec)	Average 0.095 mm (Meets)	Average 0.095 mm (Meets)	Similar
Fingertip Thickness (ASTM-D-5250-06 general requirement: 0.086 mm min, see page 4 for subject device spec)	Average 0.09 mm (Meets)	Average 0.09 mm (Meets)	Similar
Residual Powder (ASTM D6124-06 Standard Test Method, < 2 mg per glove, no defect glove)	Testing result indicates the weight of all types of residual or powder on finished powder-free gloves as < 2 mg per glove and there is no defect glove found according to ASTM D6124-06. (Meets)	Testing result indicates the weight of all types of residual or powder on finished powder-free gloves as < 2 mg per glove and there is no defect glove found according to ASTM D6124-06. (Meets)	Similar
Pinhole Results (ASTM D5151-06, AQL 2.5 met - i.e., less than two pieces gloves out of 125 pieces gloves)	Testing result indicates pinhole were found less than two pieces gloves out of 125 pieces gloves. AQL 2.5 is met. (Meets)	Testing result indicates pinhole were found less than two pieces gloves out of 125 pieces gloves. AQL 2.5 is met. (Meets)	Similar
Biocompatibility Result: Primary Skin Irritation (Not an irritant)	Under the conditions of the study, the subject device is not an irritant. (Meets)	Under the conditions of the study, the subject device is not an irritant. (Meets)	Similar
Before Aging: Tensile Strength (Mpa) (ASTM-D-5250-06 requirement: 15Mpa min)	Average Tensile Strength (Mpa): 16.96 (Meets)	Average Tensile Strength (Mpa): 16.96 (Meets)	Similar
Before Aging: Ultimate Elongations (%) (ASTM-D-5250-06 requirement: 495% min)	Average Ultimate Elongations: 519% (Meets)	Average Ultimate Elongations: 519% (Meets)	Similar
After Aging: Tensile Strength (Mpa) (ASTM-D-5250-06 requirement: 13Mpa min)	Average Tensile Strength (Mpa): 14.92 (Meets)	Average Tensile Strength (Mpa): 14.92 (Meets)	Similar
After Aging: Ultimate Elongations (%) (ASTM-D-5250-06 requirement: 415% min)	Average Ultimate Elongations: 480% (Meets)	Average Ultimate Elongations: 480% (Meets)	Similar
Dermal Sensitization (Not a sensitizer)	Under the conditions of the study, the subject device is not an sensitizer. (Meets)	Under the conditions of the study, the subject device is not an sensitizer. (Meets)	Similar

2. Sample size used for the test set and the data provenance

Test Set Sample Size:
- For Pinhole Results: 125 pieces of gloves.
- For other physical and performance characteristics, the document states "Inspection Level S-2, AOL 2.5," which refers to sampling plans defined in standards like ASTM D-5250-06 or ISO 2859-1. The exact number of samples tested for each characteristic is not explicitly stated as a single number but is determined by the AQL (Acceptance Quality Limit) and inspection level.
Data Provenance: Not explicitly stated, but based on the manufacturer's location (Zibo, Shandong, China) and the testing standards used (ASTM), the testing would likely have been conducted in China or by a laboratory accredited to perform these tests for a Chinese manufacturer. The data appears to be prospective as it is generated for the purpose of a 510(k) submission.

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 to this type of device. The "ground truth" for patient examination gloves is established through objective, standardized physical and chemical tests (e.g., tensile strength, elongation, pinhole detection, residual powder) according to recognized ASTM standards, rather than through expert consensus on qualitative assessments.

4. Adjudication method for the test set

Not applicable. As noted above, the "truth" is determined by objective measurement against established physical and chemical standards, not by human interpretation or adjudication.

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 device is a patient examination glove and does not involve AI or human "readers" in its function or evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical product, not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for this device is based on objective, quantitative measurements obtained through standardized physical and chemical testing methods, as defined by ASTM (American Society for Testing and Materials) standards. This includes:

ASTM D-5250-06 for physical and dimensional testing (e.g., length, width, thickness, tensile strength, elongation).
ASTM D-6124-06 for residual powder content.
ASTM D-5151-06 for pinhole detection.
Biocompatibility tests (primary skin irritation and dermal sensitization) performed under controlled conditions.

8. The sample size for the training set

Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI models.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for this type of device, no ground truth was established for it.

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing to the right, stacked on top of each other.

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

June 27, 2017

Zibo Yue Fan Medical Products Co, Ltd. % Kevin Wang Official Correspondent Intco Medical Industries, Inc. 805 Barrington Avenue Ontario, California 91764

Re: K170735

Trade/Device Name: Powder-Free Clear Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: May 19, 2017 Received: May 26, 2017

Dear Kevin Wang:

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,

James P. Bertram -S

for

CDR Lori A. 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) K170735

Device Name

Powder-free Clear Vinyl Patient Examination Gloves

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

的 FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image contains the logo for Zibo Yue Fan Medical Products Co., Ltd. The logo features a blue circle with a white hand inside on the left. To the right of the logo is the company name in bold, black text. There is a black line underneath the company name.

No.108 Waniie Road. Yuqiao Industrial Park, Zibo. Shandong, China. Postal Code: 255000

510(K) SUMMARY

K170735

Submitter / 510(k) Sponsor

Zibo Yue Fan Medical Products Co., Ltd. No.108 Wanjie Road. Yuqiao Industrial Park, Zibo. Shandong, China. Postal Code: 255000

Contact Person

Kevin Wang Official Correspondent Phone: 909 980 1678 Email: kevinwang@intcous.com

Summary Preparation Date

June 20, 2017

Type of 510(k) Submission

Traditional

Trade Name/ Classification

Name of Device/Trade Name: Powder Free Clear Vinyl Patient Examination Glove Classification: 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

Device Description

Subject device: Powder Free Clear Vinyl Patient Examination Glove Color: Clear Overall Length: 230mm min Width: 94mm min

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Image /page/4/Picture/0 description: The image shows the logo for Zibo Yue Fan Medical Products Co., Ltd. The logo includes a blue circle with a white hand inside. The text "Zibo Yue Fan Medical Products Co., Ltd." is written in bold, black letters.

No.108 Waniie Road. Yuqiao Industrial Park, Zibo. Shandong, China. Postal Code: 255000

Palm Thickness: 0.09 mm min Fingertip Thickness: 0.086 mm min

Non clinical performance tests

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 Powder Free Clear Vinyl Patient Examination Glove 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, 80LYZ, 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.

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Image /page/5/Picture/0 description: The image shows the logo for Zibo Yue Fan Medical Products Co., Ltd. The logo features a blue circle with a white hand inside on the left. The company name is written in bold black letters to the right of the logo. There is a black line underneath the company name.

No.108 Wanjie Road. Yuqiao Industrial Park, Zibo. Shandong, China. Postal Code: 255000

DeviceCharacteristics	Proposed Device	Predict Device	ComparisonConclusion
Product Name	Powder Free Clear VinylPatient Examination Glove	Powder free PVC VinylExam Gloves
510(k) Number	K170735	K142703
Product Owner	Zibo Yue Fan MedicalProducts Co., Ltd.	Hebei Grandeast PlasticProducts Co., Ltd.
Product Code	LYZ	LYZ	Same
Intended Use	Disposable device intendedfor medical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner	Disposable device intendedfor medical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner	Same
Regulation Number	21 CFR 880.6250	21 CFR 880.6250	Same
Sizes	SmallMediumLargeExtra-Large	SmallMediumLargeExtra-Large	Same
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
FingertipThickness	Average 0.09 mm	Average 0.09 mm	Similar
Residual Powder	According to ASTMD6124-06 Standard TestMethod for ResidualPowder on Medical glovesfor the determination ofresidual powder content.Testing result indicates theweight of all types ofresidual or powder onfinished powder-freegloves as < 2 mg per gloveand there is no defect glove	According to ASTMD6124-06 Standard TestMethod for ResidualPowder on Medical glovesfor the determination ofresidual powder content.Testing result indicates theweight of all types ofresidual or powder onfinished powder-freegloves as < 2 mg per gloveand there is no defect glove	Similar
	found according to ASTMD6124-06.	found according to ASTMD6124-06.
Pinhole Results	According to ASTMD5151-06, Testing resultindicates pinhole werefound less than two piecesgloves out of 125 piecesgloves. AQL 2.5 is met.	According to ASTMD5151-06, Testing resultindicates pinhole werefound less than two piecesgloves out of 125 piecesgloves. AQL 2.5 is met.	Similar
BiocompatibilityResult: PrimarySkin Irritation	Under the conditions of thestudy, the subject device isnot an irritant	Under the conditions of thestudy, the subject device isnot an irritant	Similar
Before Aging:TensileStrength(Mpa) andUltimateElongations	Average Tensile Strength(Mpa): 16.96Average UltimateElongations: 519%	Average Tensile Strength(Mpa): 16.96Average UltimateElongations: 519%	Similar
After Aging:TensileStrength(Mpa) andUltimateElongations	Average Tensile Strength(Mpa): 14.92Average UltimateElongations: 480%	Average Tensile Strength(Mpa): 14.92Average UltimateElongations: 480%	Similar
DermalSensitization	Under the conditions of thestudy, the subject device isnot an sensitizer	Under the conditions of thestudy, the subject device isnot an sensitizer	Similar

TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES

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Image /page/6/Picture/0 description: The image shows a blue circular sign with a white hand in the center. The hand is depicted with fingers pointing upwards and a wrist or cuff at the bottom. The sign is likely used to indicate a warning or instruction related to hand safety or hygiene.

Zibo Yue Fan Medical Products Co., Ltd.

No.108 Wanjie Road. Yuqiao Industrial Park, Zibo. Shandong, China. Postal Code: 255000

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.

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.