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 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 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the "Powder Free Vinyl Patient Examination Gloves," based on the provided document:

This document is a 510(k) premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device. The information provided focuses on demonstrating that the new device performs at least as well as the predicate device and meets established standards. It does not describe an AI/ML device, so certain categories related to AI performance, such as multi-reader multi-case studies, effect size, and stand-alone algorithm performance, are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on established ASTM standards and FDA requirements for patient examination gloves. The reported device performance is indicated as "Meets" for all tested characteristics, signifying compliance with these standards.

Characteristics	Standard / Acceptance Criteria	Device Performance (Subject Device)	Result of Comparison (to Predicate)
Product Code	LYZ (Predicate device code)	LYZ	Substantial equivalence
Intended Use	Predicate device's intended use	Predicate device's intended use	Substantial equivalence
Labeling	No special labeling claims / no hypoallergenic claim	No special labeling claims / no hypoallergenic claim	Substantial equivalence
Device Materials	Vinyl (Predicate device material)	Vinyl	Substantial equivalence
Color	Clear (Predicate device color)	Clear	Substantial equivalence
Tensile strength (before and after aging)	ASTM D 5250-06 (Reapproved 2011)	Meets	Substantial equivalence
Ultimate elongation (before and after aging)	ASTM D 5250-06 (Reapproved 2011)	Meets	Substantial equivalence
Freedom from pinholes	ASTM D 5250-06 (Reapproved 2011) & 21CFR800.20	Meets	Substantial equivalence
Dimensions: Overall length, Width, Palm and Finger thickness	ASTM D 5250-06 (Reapproved 2011)	Meets	Substantial equivalence
Residual powder	ASTM D 5250-06 (Reapproved 2011) & ASTM D6124-06 (Reapproved 2011)	Meets	Substantial equivalence
Primary skin irritation test	ISO 10993-10	Not an irritant	Substantial equivalence
Dermal sensitization assay	ISO 10993-10	Not a sensitizer	Substantial equivalence

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

The document does not explicitly state the sample sizes for each specific test (e.g., tensile strength, pinholes, biocompatibility). However, it implies that the tests were conducted according to the methodology outlined in the cited ASTM and ISO standards, which would specify appropriate sample sizes.

Data Provenance: The tests were conducted by the manufacturer, Ever Light Plastic Products Co., Ltd., based in Donggao Industrial Zone, Zanhuang, Shijiazhuang, Hebei, China. The data would therefore be prospective data generated from their product testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to this type of device submission. The "ground truth" for the performance of these examination gloves is established by objective measurements and standardized test methods (e.g., ASTM, ISO standards) rather than expert consensus on diagnostic interpretations. The tests are physical and chemical property assessments.

4. Adjudication method for the test set

Not applicable. As the tests involve objective physical and chemical property measurements against established standards, there is no need for an adjudication method by experts. The results are quantitative and directly assess compliance with the standard's specifications.

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 as the device is a vinyl patient examination glove, not an AI/ML device requiring human reader interaction or interpretation.

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

This is not applicable as the device is a vinyl patient examination glove, not an AI/ML algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on objective, standardized measurements against internationally recognized specifications and test methods. Specifically:

ASTM D 5250-06 (Reapproved 2011) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application: This standard defines the acceptable ranges and methods for testing physical properties like tensile strength, elongation, dimensions, freedom from pinholes, and residual powder.
ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization: This standard defines the methodology for biocompatibility testing related to skin irritation and sensitization.
21 CFR 800.20: This FDA regulation pertains to specific requirements for medical devices, which includes aspects like freedom from holes.
21 CFR 807.92: This specifies requirements for the 510(k) summary.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML model that requires a training set. The manufacturing process of examination gloves is based on engineering specifications and quality control, not machine learning.

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

This is not applicable as there is no training set for this type of medical device.

Summary

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

December 17, 2014

Ever Light Plastic Products Company, Ltd. C/O Ms. Kathy Liu Project Manager Hongray USA Medical Products, Inc. 3973 Schaefer Avenue Chino, CA 91710

Re: K142571

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: November 11, 2014 Received: November 14, 2014

Dear Ms. 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.

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Page 2 - Ms. Liu

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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

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Indications for Use

510(k) Number (if known) K142571

Device Name

Powder Free Vinyl Patient Examination Gloves

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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000

Product: Powder Free Vinyl Patient Examination Gloves

510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR §807.92.

The assigned 510(K) number is: __

1. Owner's Identification:

Mr. Zhang Litao Ever Light Plastic Products Co., Ltd. Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000

Tel: 86-311-83601854 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: December 11 , 2014

2. Name of the Device:

Trade Name: Powder Free Vinyl Patient Examination Gloves 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. Synthetic Vinyl Patient Examination Gloves-Powder Free (K060778)

4. Device Description:

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Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000

Product: Powder Free Vinyl Patient Examination Gloves

5. Intended Use of the Device:

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 and Substantial Equivalence:

Ever Light Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves is substantially equivalent in safety and effectiveness to the Ever Light Plastic Products Co., Ltd.'s Synthetic Vinyl Patient Examination Gloves-Powder Free (K 060778). The subject device and predicate device use a similar plastic flexible barrier film to achieve a device for the intended use.

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

Characteristics	Standard	Device Performance		Result ofcomparison
Product Code	/	LYZ	LYZ	Substantialequivalence
Intended Use	/	Predicate device isdisposable non-sterile deviceintended formedical purposethat is worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer.	Subject device isdisposable non-sterile deviceintended formedical purposethat is worn on theexaminer's hand orfinger to preventcontaminationbetween patient andexaminer.	Substantialequivalence
Labeling	/	There are no speciallabeling claims anddo not claim glovesas hypoallergenicon labels.	There are no speciallabeling claims anddo not claim glovesas hypoallergenicon labels.	Substantialequivalence
Device Materials	/	Vinyl	Vinyl	Substantialequivalence
Color	/	Clear	Clear	Substantialequivalence
Device tolerances and specifications & Performance Data:
Tensile strength:before and afteraging	ASTMD 5250-06(2011)	Meets	Meets	Substantialequivalence
Characteristics	Standard	Device Performance		Result of comparison
		Predicate device	Subject Device
Ultimate elongation: before and after aging	ASTM D 5250-06 (2011)	Meets	Meets	Substantial equivalence
Freedom from pinholes	ASTM D 5250-06 (2011)	Meets	Meets	Substantial equivalence
Dimensions: Overall length, Width, Palm and Finger thickness	ASTM D 5250-06 (2011)	Meets	Meets	Substantial equivalence
Residual powder	ASTM D 5250-06 (2011)	Meets	Meets	Substantial equivalence
Biocompatibility
Primary skin irritation test	ISO 10993-10	Under conditions of the study, not an irritant	Under conditions of the study, not an irritant	Substantial equivalence
Dermal sensitization assay	ISO 10993-10	Under conditions of this study, not a sensitizer.	Under conditions of this study, not a sensitizer.	Substantial equivalence
Indications For Use	/	Predicate device 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.	Subject device 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.	Substantial equivalence

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Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000

Product: Powder Free Vinyl Patient Examination Gloves

Ever Light Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves 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(2011), biocompatibility requirement and FDA requirements and the labeling claims for the product. It performs as well as the legally marketed predicate device.

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Donggao Industrial Zone Zanhuang, Shijiazhuang, Hebei, China 050000

Product: Powder Free Vinyl Patient Examination Gloves

Equivalence is as Follows:
Characteristics	Applicable FDA- RecognizedStandards	Performance Results
Dimensions	ASTM D 5250-06(2011)	Meets
Physical Properties	ASTM D 5250-06(2011)	Meets
Freedom from holes	ASTM D 5250-06(2011)ASTM D5151-06(2011)21CFR800.20	Meets
Residual Powder Test	ASTM D 5250-06(2011)ASTM D6124-06(Reapproved 2011)	Meets
Primary Skin Irritation andSkin Sensitization	ISO 10993 Part 10	Meets

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial

8. Discussion of Clinical Tests Performed:

Not Applicable – There is no hypoallergenic Claim. There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the nonclinical testing.

9. Labeling:

We do not claim our gloves as hypoallergenic on our labels.

10. Conclusions:

Ever Light Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves conform fully to ASTM D 5250-06 (2011) standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data discussed above. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.

Drawn from the complete list of non-clinical tests, the device herein mentioned 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.