A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Powder Free Vinyl Patient Examination Gloves (Yellow, White) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2015) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for Powder Free Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through clinical studies in the typical sense of AI/software devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" here refer to compliance with recognized standards and performance thresholds for examination gloves.

Here's a breakdown of the requested information based on the provided text, interpreted in the context of a medical glove submission:

1. A table of acceptance criteria and the reported device performance

Testing Items	Acceptance Criteria (FDA-recognized Standard Requirements)	Reported Device Performance (Actual Testing Results)	Conclusion
Overall Length (mm)	230 mm for all sizes minimum	S: 233-244mm, M: 231-241mm, L: 230-243mm, XL: 234-242mm	Pass
Width (mm)	S: 85±5, M: 95±5, L: 105±5, XL: 115±5	S: 87-88 mm, M: 97-98 mm, L: 107-108 mm, XL: 118-119 mm	Pass
Palm Thickness (mm)	0.08mm minimum	0.08mm	Pass
Finger Thickness (mm)	0.05mm minimum	0.09-0.12mm	Pass
Tensile Strength (Mpa) - Before aging	11Mpa minimum	15.1-18.1Mpa	Pass
Tensile Strength (Mpa) - After aging	11Mpa minimum	14.9-17.7Mpa	Pass
Ultimate Elongation (%) - Before aging	300% minimum	390-470%	Pass
Ultimate Elongation (%) - After aging	300% minimum	380-490%	Pass
Pinhole	ASTM D 5250-06 (2015) requirements / Meet AQL 2.5 requirements	Meets AQL 2.5 requirements	Pass
Residual Powder	Not more than 2mg per glove	0.18 mg/glove	Pass
Primary Skin Irritation Test	Under conditions of the study, not an irritant	Under conditions of the study, not an irritant	Pass
Dermal Sensitization Study	Under conditions of the study, not a sensitizer	Under conditions of the study, not a sensitizer	Pass
Cytotoxicity Test	Under the conditions of this study, not a cytotoxic potential	Under the conditions of this study, not a cytotoxic potential	Pass
Overall Performance	Meets ASTM D5250-06 (Reapproved 2015) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application	Conforms fully to ASTM D 5250-06 (2015) standard, applicable 21 CFR references, and FDA requirements	Overall Compliance Demonstrated

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The sample sizes are indicated by the "Inspection Level and AQL" (Acceptable Quality Limit) for most physical and performance tests, such as S-2, AQL4.0, and G-I, AQL2.5. For Residual Powder, the sample size was N=5. These AQL levels refer to sampling plans (e.g., ISO 2859-1 or ANSI/ASQ Z1.4), where a specific number of units are inspected from a lot, and the lot is accepted or rejected based on the number of defects found. The exact number of units tested isn't explicitly stated but would be determined by the AQL tables for the lot size.
Data Provenance: The manufacturing entity is Shanxi Hongjin Plastic Technology Co., LTD, located in China. The testing would have been conducted by or on behalf of this company. The data is prospective in the sense that it's generated for the purpose of demonstrating compliance for this submission.

3. 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)

This product is a medical device (patient examination gloves) tested against recognized physical, chemical, and biological standards. "Ground truth" in this context is established by the accepted scientific methodologies and criteria outlined in the ASTM and ISO standards, rather than expert human interpretation in the way it applies to diagnostic AI. Therefore, there are no "experts" in the sense of clinicians establishing ground truth for individual cases. The ground truth is the objective measurement against the specified standard requirements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in medical image reading). For device performance testing against quantitative standards, the measurements are objective.

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 physical product (medical glove), not an AI or software algorithm. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the performance tests in this submission is the objective measurement against scientifically established and recognized standards (e.g., ASTM D5250-06 for physical properties, specific thresholds for residual powder, and standard biocompatibility tests for irritation and sensitization). It is not pathology, outcomes data, or expert consensus on a diagnostic interpretation.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no training set in that context. Statistical sampling is used for quality control during manufacturing and for conformity testing.

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

Not applicable. As there is no training set for a machine learning model, this question is not relevant.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 12, 2018

Shanxi Hongjin Plastic Technology Co., Ltd % Kathy Liu Project Manager Hongray USA Medical Products Inc 3973 Schaefer Ave., Chino, CA 91710 US

Re: K180260

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves (Yellow, White) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LYZ Dated: May 16, 2018 Received: May 30, 2018

Dear Kathy Liu:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Elizabeth F. Claverie -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) K180260

Device Name

Powder Free Vinyl Patient Examination Gloves (Yellow, White)

Indications for Use (Describe)

A patient examination glove is disposable non-sterile device intended for medical purpose 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)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province, China 042399

Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White)

510(K) SUMMARY

The assigned 510(K) number is: K180260

1. Owner's Identification :

Mr. Wu Zhigang Shanxi Hongjin Plastic Technology Co., LTD Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province, China 042399

Tel: 86-311-66179653 Fax: 86-311-83616934

Contact: Ms. Kathy Liu, Project Manager Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611 Fax: 909-590-1511 Date Summary Prepared: May 16, 2018

2.Name of the Device:

Trade Name: Powder Free Vinyl Patient Examination Gloves (Yellow, White) Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Regulation: 880.6250 Classification Panel: 880 General Hospital and Personal Use Product Code: LYZ Device Class: Class I

3. Predicate Device Information:

Ever Light Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves (Yellow, White, Blue, Pink) (K142570)

4. Device Description:

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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province, China 042399

Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White)

5. Indications for Use Statement for these Devices:

A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

6. Technological Characteristics Comparison:

The properties between the subject device and the predicate device are compared in the following table:

Characteristics	Device Performance		Result ofcomparison
	Predicate device	Subject Device
Product Code	LYZ	LYZ	Same
Intended Use	Predicate device isdisposable non-steriledevice intended formedical purpose that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner.	Subject device isdisposable non-steriledevice intended formedical purpose that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner.	Same
Labeling	There are no speciallabeling claims	There are no speciallabeling claims	Same
Device Materials	Vinyl	Vinyl	Same
Color	Yellow White Blue Pink	Yellow White	Different
Specifications & Performance Data:
physical Properties	Meets ASTM D 5250-06(2015) requirements	Meets ASTM D 5250-06(2015) requirements	Same
Freedom frompinholes	Meets ASTM D 5250-06(2015) requirements	Meets ASTM D 5250-06(2015) requirements	Same
Dimensions:	Meets ASTM D 5250-06(2015) requirements	Meets ASTM D 5250-06(2015) requirements	Same
Residual powder	Meets ApplicableDefinition for PowderFree; ≤ 2 mg per glove	Meets ApplicableDefinition for PowderFree; ≤ 2 mg per glove	Same
Biocompatibility
Primary skinirritation test	Under conditions of thestudy, not an irritant	Under conditions of thestudy, not an irritant	Same
Dermal	Under conditions of the	Under conditions of the	Same

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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province, China 042399

Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White)

Characteristics	Device Performance		Result ofcomparison
	Predicate device	Subject Device
sensitizationassay	study, not a sensitizer	study, not a sensitizer

Shanxi Hongjin Plastic Technology Co., Ltd's Powder Free Vinyl Patient Examination Gloves (Yellow, White) shares the same or comparable technology characteristics compared to the predicate device. The subject device performs according to the glove performance standards ASTM D5250-06(2015), biocompatibility requirement and FDA requirements and the labeling claims for the product.

7. Discussion of Non-Clinical Performance Tests

Testing Items	FDA-recognizedStandardRequirements	InspectionLevel andAQL	Actual TestingResults	Conclusion
Overall Length(mm)	230 for all sizesminimum	S-2, AQL4.0	S: 233-244mmM:231-241mmL:230-243mmXL: 234-242mm	Pass
Width(mm)	S: 85±5M: 95±5L: 105±5XL: 115±5	S-2, AQL4.0	87-88 mm97-98 mm107-108 mm118-119 mm	Pass
PalmThicknesss (mm)	0.08mmminimum	S-2, AQL4.0	0.08mm	Pass
FingerThicknesss (mm)	0.05mmminimum	S-2, AQL4.0	0.09-0.12mm	Pass
Tensile Strength (Mpa)	Before agingAfter aging	S-2, AQL4.0	11Mpa minimum11Mpa minimum	15.1-18.1Mpa14.9-17.7Mpa	PassPass
Ultimate Elongation (%)	Before agingAfter aging	S-2, AQL4.0	300% minimum300% minimum	390-470%380-490%	PassPass
Pinhole	2.5	G-I	meet AQL2.5requirements	Pass
Residual	Not more than	N=5	0.18 mg/glove	Pass

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Coal Bed Gas Industrial Zone, Qu'e Town, Daning County, Linfen City, Shanxi Province, China 042399

Product: Powder Free Vinyl Patient Examination Gloves (Yellow, White)

Powder	2mg per glove
Primary SkinIrritation Test	Under conditions of the study, notan irritant	Under conditions of the study, notan irritant
DermalSensitizationStudy	Under conditions of the study, nota sensitizer	Under conditions of the study, nota sensitizer
CytotoxicityTest	Under the conditions of thisstudy, not a cytotoxic potential	Under the conditions of this study,not a cytotoxic potential

8.Clinical Performance Tests:

Clinical testing is not needed for this device.

9._Conclusion:

Shanxi Hongjin Plastic Technology Co., Ltd's Powder Free Vinyl Patient Examination Gloves (Yellow, White) conform fully to ASTM D 5250-06 (2015) standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data discussed above. Based on the performed nonclinical tests, the device is as safe, as effective, and performs as well as the legally marketed predicate 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.