Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

AI/ML Overview

The provided document is a 510(k) premarket notification for Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color. It describes the device, its intended use, and a study to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristics	Standard / Acceptance Criteria	Device Performance
Dimension	ASTM D 6319-10.	Meets
Physical Properties	ASTM D 6319-10.	Meets
Freedom from pinholes	21 CFR 800.20 (Holes at Inspection Level I, AQL 2.5)	Meets
Powder Residual	ASTM D 6319-10 and D6124-06 (Reapproved 2011)	Meets (<2mg/glove)
Biocompatibility	Primary Skin Irritation (ISO 10993-10: Third Edition 2010-08-01)	Under the conditions of the study, the subject device is non-irritating
Biocompatibility	Dermal sensitization (ISO 10993-10: Third Edition 2010-08-01)	Under the conditions of the study, the subject device is not a sensitizer
Length	ASTM D6319-10 (≥230mm min)	Meets ASTM D6319-10 (≥230mm min for all sizes)
Width	ASTM D6319-10 (Small 70-90 mm, Medium 85-105mm, Large 100-120mm, Xlarge 110-130 mm)	Meets ASTM D6319-10 (Small 70-90 mm, Medium 85-105 mm, Large 100-120 mm, X large 110-130 mm)
Thickness	ASTM D6319-10 (Finger 0.05mm min., Palm 0.05mm min.)	Thickness (mm) min.: Finger 0.05 mm min., Palm 0.05 mm min.
Physical Properties (before aging/after aging)	ASTM D6319-10 (Elongation ≥500%, Tensile Strength ≥ 14MPa)	Meets ASTM D6319-10 (Before aging/after aging: Elongation ≥500%, Tensile Strength ≥ 14MPa)
Freedom from Pinholes (additional)	ASTM D6319-10, ASTM D 5151-06 (Reapproved 2011)	Meets
Residual Powder (additional)	ASTM D 6124-06 (Reapproved 2011) below 2mg	Results generated values below 2mg of residual powder
Biocompatibility (additional)	ISO 10993-10:2002/Amd.1:2006 for Skin Irritation and Dermal Sensitization	Meets ISO 10993-10: Third Edition 2010-08-01. Not an irritant and not a sensitizer.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample size used for the test set of the device's performance characteristics. It references compliance with ASTM standards, which would imply that the testing was conducted according to the sampling plans outlined within those standards for things like AQL (Acceptable Quality Level) for pinholes.

The data provenance is not explicitly stated in terms of country of origin for the testing, but the company itself is based in China. The testing appears to be prospective as it's being conducted on the subject device to gain regulatory clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The testing described for this device (patient examination gloves) relies on standardized physical, chemical, and biological tests rather than expert consensus on diagnostic images or clinical outcomes. For example, biocompatibility testing (skin irritation, sensitization) would typically be performed in a laboratory setting by trained toxicologists or biologists, but the number and specific qualifications of these individuals are not detailed in this regulatory submission.

4. Adjudication Method for the Test Set

This information is not applicable to the type of device and testing described. Adjudication methods like 2+1 or 3+1 typically apply to studies where multiple human readers are interpreting data (e.g., medical images) and their disagreements need to be resolved to establish ground truth. The tests for these gloves are objective measurements against established standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices, not for basic medical devices like examination gloves. The document explicitly states: "Clinical data was not needed for this submission."

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

Not applicable. This device is an examination glove, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by objective performance specifications defined by recognized consensus standards (e.g., ASTM D6319-10, ASTM D6124-06, 21 CFR 800.20, ISO 10993-10). For example, for "Freedom from pinholes," the ground truth is whether the glove meets the AQL 2.5 requirement as tested according to ASTM D5151-06. For "Biocompatibility," the ground truth is the scientific conclusion from standardized animal or in vitro tests regarding irritation and sensitization.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device is not an AI/ML algorithm.

Summary

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

March 17, 2016

Jiayuan Medical Products Co., Ltd % Chu Xiaoan Official Correspondent Room 1606 Bldg. 1 Jianxiang Yuan No 209 Bei Si Huan Zhong Rd Haidian District Beijing, 100083 CHINA

Re: K152705

Trade/Device Name: Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 28, 2016 Received: February 1, 2016

Dear Chu Xiaoan:

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

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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 (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 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 yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin Keith, M.S. Division 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) K152705

Device Name

Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 6 510(k) Summary

510(K) Summary

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

"The assigned 510(k) number is: K152705 ニ

Premarket Notification [510(k)] Summary

1.0 Submitter:

Submitter's name :	Jiayuan Medical Products Co.,Ltd.
Submitter's address :	Xihuan Road, Luannan County, TangshanCity, 063500 Hebei Province ,China
Phone number :	(86)315-4160678
Fax number :	(86)315-4168700
Name of contact person:	Wang Lihong
Date of preparation :	2016-03-01

2.0 Name of the Device

Device Name:	Nitrile Powder Free Patient ExaminationGloves, Blue Color
Proprietary/Trade name:	Jiayuan Nitrile Powder Free PatientExamination Gloves, Blue Color
Common Name:	Exam gloves
Classification Name:	Patient examination glove
Device Classification:	I
Regulation Number:	21 CFR 880.6250
Panel:	General Hospital (80)
Product Code:	LZA

3.0 Predicate device

Device Name:	Nitrile Powder Free Patient Examination Gloves,Blue Color
Company name:	Tangshan Zhonghong Pulin Plastic Co.,Ltd.
510(K) Number:	K120970

4.0 Device Description:

4.1 How the device functions:

Nitrile films form a barrier to body fluids and bloodborne Pathogens

4.2 Scientific concepts that form the basis for the device

The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a

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medical procedure.

4.3 Physical and performance characteristics such as design, materials and physical properties:

Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

5.0 Device Intended Use (Indication for use):

6.0 Summary of the Technological Characteristics of the Device:

The Nitrile Powder Free Patient Examination Gloves, Blue Color, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

Characteristics	Standard	Device performance
Dimension	ASTM standard D 6319-10.	Meets
Physical Properties	ASTM standard D 6319-10.	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 6319-10 andD6124-06(Reapproved 2011).	Meets<2mg/glove
Biocompatibility	Primary Skin Irritation in rabbitsISO 10993-10: Third Edition2010-08-01.Dermal sensitization in theguinea pig ISO 10993-10: ThirdEdition 2010-08-01.	Under the conditions of thestudy, the subject device isnon-irritatingUnder the conditions of thestudy, the subject device isnot a sensitizer

7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data:

Nitrile Powder Free Patient Examination Gloves, Blue Color, meet requirements per ASTM D6319-10.per ASTM D6124-06(Reapproved 2011), per 21 CFR 800.20 and ISO 10993-10: Third Edition 2010-08-01.

The performance test data of the non clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.

Substantial Equivalent Based on Assessment of Clinical Performance Data: 8.0

Clinical data was not needed for this submission

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Features&Description	Predicate Device	Subject Device	Result ofComparison
Company	Tangshan Zhonghong PulinPlastic Co.,Ltd.	Jiayuan Medical Products Co.,Ltd.	--
510(K) Number	K120970	K152705	--
Device name	Nitrile Powder Free PatientExamination Gloves, BlueColor	Nitrile Powder Free PatientExamination Gloves, Blue Color	same
Product Code	LZA	LZA	same
Size	Small/Medium/Large/X large	Small/Medium/Large/X large	same
Intend for use	Nitrile Powder Free PatientExamination Gloves, BlueColor is a disposable deviceintended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contaminationbetween patient andexaminer.	Nitrile Powder Free PatientExamination Gloves, Blue Color isa disposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner.	Substantiallyequivalent
DeviceDescription andSpecifications	Meets ASTM D6319-10	Meets ASTM D6319-10	Substantiallyequivalent
Dimensions--Length	Meets ASTMD6319-10≥230mm min	Meets ASTMD6319-10≥230mm min for all sizes	Substantiallyequivalent
Dimensions-- Width	Meets ASTM D6319-10	Meets ASTM D6319-10	Substantiallyequivalent
	Small 70-90 mmMedium 85-105mmLarge 100-120mmXlarge 110-130 mm	Small 70-90 mmMedium 85-105 mmLarge 100-120 mmX large 110-130 mm
Dimensions--Thickness	Meets ASTM D6319-10		Substantiallyequivalent
	Finger 0.05mm min.Palm 0.05mm min.	Thickness (mm) min.Finger 0.05 mm min.Palm 0.05 mm min.
PhysicalProperties	Meets ASTM D D6319-10Before aging/after agingElongation≥500%Tensile Strength≥ 14MPa	Meets ASTMD D6319-10Before aging/after agingElongation≥500%Tensile Strength≥ 14MPa	Substantiallyequivalent
FreedomfromPinholes	Meets• 21 CFR 800.20• ASTM D6319-10• ASTM D 5151-06(Reapproved 2011)	Meets• 21 CFR 800.20• ASTM D6319-10• ASTM D 5151-06(Reapproved 2011)Holes atInspection Level IAQL2.5	Substantiallyequivalent

ResidualPowder	Meets ASTMD 6124-06(Reapproved 2011)below 2mg of residualpowder	Meets ASTMD 6124-06(Reapproved 2011)Results generated values below2mg of residual powder	Substantiallyequivalent
Materials usedto fabricate thedevices	Nitrile	Nitrile	Substantiallyequivalent
Dusting orDonningPowder: name	PU	Polyurethane	Substantiallyequivalent
Compareperformancedata supportingsubstantialequivalence	MeetsASTM D5151-06(Reapproved 2011)ASTM D6319-10ASTM D6124-06(Reapproved 2011)	MeetsASTM D5151-06(Reapproved 2011)ASTM D6319-10ASTM D6124-06(Reapproved 2011)	Substantiallyequivalent
Single PatientUse	Single Patient Use	Single Patient Use	Substantiallyequivalent
Biocompatibility	SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006	SKIN IRRITATION DERMALand SENSITIZATION STUDIESMeets ISO 10993-10: ThirdEdition 2010-08-01.Under the conditions of the study,not an irritant and underconditions of the study, not asensitizer.	Substantiallyequivalent
Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed.	-Powder Free-Patient Examination Glove-Single Use Only- Manufactured For:- Lot-Blue color	-Powder Free-Patient Examination Glove-Single Use Only- Manufactured For:- Lot-Blue color	Substantiallyequivalent

9.0 Substantial Equivalence Comparison:

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10.0 Substantial Equivalence Comparison:

It can be concluded that the Nitrile Powder Free Patient Examination Gloves, Blue Color meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims.

It can be concluded that the Nitrile Powder Free Patient Examination Gloves, Blue is as safe, as effective, and performs as well as the predicate device, Nitrile Color Powder Free Patient Examination Gloves, Blue Color, Tangshan Zhonghong Pulin Plastic Co., Ltd.. K120970.

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.