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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-10.

AI/ML Overview

The provided document describes the acceptance criteria and performance of Hongye Plastic Products Co., Ltd.'s Powder Free Nitrile Examination Gloves. However, it does not describe an AI device or a study involving AI. Therefore, I cannot provide information related to AI-specific aspects like training sets, ground truth for training sets, MRMC studies, or standalone algorithm performance.

The document details the device's adherence to established standards for medical examination gloves to demonstrate substantial equivalence to a predicate device, as required for a 510(k) submission to the FDA.

Here's the information based on the provided text, focusing on the device's performance against its acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
Product Code	LZA
Intended Use (disposable non-sterile device for medical purposes, worn on hand/finger to prevent contamination)	Meets
Labeling (no special labeling claims, no hypoallergenic claims)	Meets
Device Materials	Nitrile Compound (Black, White, Green)
Tensile strength: before and after aging (ASTM D6319-10)	Meets ASTM D6319-10
Ultimate elongation: before and after aging (ASTM D6319-10)	Meets ASTM D6319-10
Freedom from pinholes (ASTM D6319-10)	Meets ASTM D6319-10
Dimensions: Overall length, Width, Palm and Finger thickness (ASTM D6319-10)	Meets ASTM D6319-10
Residual powder (ASTM D6319-10, ASTM D6124)	Meets ASTM D6319-10 & ASTM D6124
Primary skin irritation test (ISO 10993 Part 10, 16CFR 1500.41, 16CFR 1500.3)	Passes (Not a primary skin irritation)
Dermal sensitization assay (ISO 10993 Part 10, 16CFR 1500.41, 16CFR 1500.3)	Passes (Not a dermal sensitization)

Summary of Study that Proves the Device Meets Acceptance Criteria:

The study described is a non-clinical performance evaluation comparing the subject device (Hongye Plastic Products Co., Ltd.'s Powder Free Nitrile Examination Gloves) to a predicate device (Hong Xin Rubber Products Co., Ltd Powder Free Nitrile Examination Gloves, Blue) and against recognized industry standards. The purpose is to demonstrate "Substantial Equivalence" as required for FDA 510(k) clearance.

The study involved testing the physical properties, dimensions, freedom from pinholes, residual powder, and biocompatibility of the subject device.

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

The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for tensile strength, pinholes, etc.). It only states that the device "Meets" the specified ASTM standards.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data provided, beyond the manufacturing location of Hongye Plastic Products Co., Ltd. being in Hebei, China.

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 information is not applicable and not provided. The "ground truth" for examination gloves is adherence to measurable physical and biological standards (e.g., tensile strength, dimensions, biocompatibility), which are typically assessed through standardized laboratory testing, not expert consensus.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments or when multiple human readers are involved in clinical studies. For physical property testing of gloves, objective measurements against a standard are performed.

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 information is not applicable. This document describes a medical device (examination gloves), not an AI system or an imaging diagnostic tool where MRMC studies would be relevant.

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

This information is not applicable. The device is a physical product (gloves) and does not involve an algorithm or AI.

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

The "ground truth" for this device is based on objective, measurable criteria established by recognized industry standards such as ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves), ISO 10993 Part 10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization), and relevant CFR regulations (e.g., 16CFR 1500.41, 16CFR 1500.3 for flammability and irritation).

8. The sample size for the training set

This information is not applicable as this is not an AI device.

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

This information is not applicable as this is not an AI device, and therefore no training set or its associated ground truth was established.

Summary

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Hongve Plastic Products Co., Ltd

Donggao Industrial Zone Zanhuang, Hebei, China 050000

EXHIBIT #1 Page 1 of 4

510(K) SUMMARY

JAN 1 7 2013

This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(K) number is: _ < \ 2 乙イ ○ 8

1. Owner's Identification:

Ms. Liu Yingxue Hongye Plastic Products Co., Ltd. Donggao Industrial Zone, Zanhuang, Hebei, China 050000 Tel: 86-311-83980319

Submitter and Contact person: Kathy Liu Address: 3973 Schaefer Ave., Chino, CA 91710 Tel: 909-590-1611 Fax: 909-590-1511 Date Summary Prepared: July 30, 2012

Date Summary Prepared: July 30, 20.

2. Name of the Device:

Hongye Plastic Products Co., Ltd. Powder Free Nitrile Examination Gloves (Black, White, Green) Common Name: Exam Gloves

3. Predicate Device Information:

Hong Xin Rubber Products Co., Ltd Powder Free Nitrile Examination Gloves, Blue (K070861)

4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-10.

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.

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Hongye Plastic Products Co., Ltd Donggao Industrial Zone Zanhuang, Hebei, China 050000

EXHIBIT #1 Page 2 of 4

6. Comparison to Predicate Devices:

Comparison to I regicate Doriees: Portecel
Hongye Plastic Products Co., Ltd.'s Powder Free Nitrile Examination Gloves (Black, Holly, I hastic Products Ook, B&I B Lear B and effectiveness to the Hong Xin Wilte, Green) is Substantially ouder Free Nitrile Examination Gloves, Blue.

Characteristics	Standard	Device Performance		Result ofcomparison
		Predicate device	Subject Device
Product Code	/	LZA	LZA	Substantialequivalence
Intended Use	/	Predicate deviceis disposablenon-steriledevice intendedfor medicalpurpose that isworn on theexaminer's handor finger topreventcontaminationbetween patientand examiner.	Subject device isdisposable non-sterile deviceintended formedical purposethat is worn onthe examiner'shand or finger topreventcontaminationbetween patientand examiner.	Substantialequivalence
Labeling	/	There are nospecial labelingclaims and donot claim glovesashypoallergenicon labels.	There are nospecial labelingclaims and donot claim glovesashypoallergenicon labels.	Substantialequivalence
Device Materials	/	NitrilecompoundBlue	NitrileCompoundBlack, White,Green	Substantialequivalence
Color	/			Different, ithave beenconfirmed tobe safety foruse
Devicetolerances andspecifications	Tensilestrength:before andafter aging	ASTMD6319-10	Meets	Meets	Substantialequivalence
Characteristics	Standard	Device Performance		Result of comparison
Devicetolerances andspecifications	Ultimateelongation:before andafter aging	ASTMD6319-10	Meets	Meets	Substantialequivalence
	Freedomfrom pinholes	ASTMD6319-10	Meets	Meets	Substantialequivalence
	Dimensions:Overalllength,Width, Palmand Fingerthickness	ASTMD6319-10	Meets	Meets	Substantialequivalence
	Residualpowder	ASTMD6319-10,ASTMD6124	Meets	Meets	Substantialequivalence
Performancedata	Tensilestrength:before andafter aging	ASTMD6319-10	Meets	Meets	Substantialequivalence
	Ultimateelongation:before andafter aging	ASTMD6319-10	Meets	Meets	Substantialequivalence
	Freedomfrom pinholes	ASTMD6319-10	Meets	Meets	Substantialequivalence
	Dimensions:Overalllength,Width, Palmand Fingerthickness	ASTMD6319-10	Meets	Meets	Substantialequivalence
	Residualpowder	ASTMD6319-10&ASTMD6124	Meets	Meets	Substantialequivalence
		Device Performance		Result of
Characteristics	Standard	Predicate device	Subject Device	comparison
Biocompatibility	Primaryskinirritationtest	PassesNot a primaryskin irritation	PassesNot a primaryskin irritation	Substantialequivalence
	Dermalsensitizationassay	PassesNot a dermalsensitization	PassesNot a dermalsensitization	Substantialequivalence

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Hongye Plastic Products Co., Ltd
Donggao Industrial Zone Zanhuang, Hebei, China 050000

EXHIBIT #1 Page 3 of 4

. .

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Hongye Plastic Products Co., Ltd

Donggao Industrial Zone Zanhuang, Hebei, China 050000

EXHIBIT #1 Page 4 of 4

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:

Characteristics	Applicable FDA- Recognized Standards	Performance Results
Dimensions	ASTM D 6319-10	Meets
Physical Properties	ASTM D 6319-10	Meets
Freedom from holes	ASTM D 6319-10	Meets
Residual Powder Test	ASTM D 6319-10ASTM D6124-06 (Reapproved 2011)	Meets
Primary Skin Irritationand Skin Sensitization	ISO 10993 Part 1016CFR 1500.4116CFR 1500.3	Meets

8. Labeling:

There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.

9. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic Claim.

10. Conclusions:

Hongye Plastic Products Co., Ltd.'s Powder Free Nitrile Examination Gloves (Black, White, Green) conform fully to ASTM D6319-10 standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, applicable 21 Of References and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial I hele are no'salecty/cricacy ibacases of the complete list of non-clinical tests, the oquiralerse - predioned is as safe and effective as the predicate device.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 17, 2013

Hongye Plastic Products Company, Limited C/O Ms. Kathv Liu Project Manager Surprotect, Incorporated 3973 Schaefer Avenue CHINO CA 91710

Re: K122408

Trade/Device Name: Powder Free Nitrile Examination Gloves (Black, White, Green) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: November 26, 2012 Received: November 27, 2012

Dear Ms. 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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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Anthong Lo nina

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Hongye Plastic Products Co., Ltd Donggao Industrial Zone Zanhuang, Hebei, China 050000

Attachment A

INDICATION FOR USE

K 199408 510 (k) NUMBER (IF KNOW): Hongye Plastic Products Co., Ltd. APPLICANT: Powder Free Nitrile Examination Gloves (Black, DEVICE NAME: White, Green)

INDICATIONS FOR USE:

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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/ OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Elizabeth F. Claverie
2013.01.16 ,14:53:22 2 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0
Division Sign-Off)	Page 1 of 1
Division of Anestheslology, General Hospital.

510(k) Number: K122408

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.