Powder Free Nitrile 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.

Device Description

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.

AI/ML Overview

The provided text is a 510(k) summary for "Powder Free Nitrile Patient Examination Gloves, Blue Color," a Class I medical device. This document is a regulatory submission to the FDA (Food and Drug Administration) to demonstrate substantial equivalence to a predicate device already on the market.

It's important to understand that a 510(k) submission for a Class I device like examination gloves does not involve the kind of "AI-driven medical device" performance evaluation that the prompt is asking for (e.g., acceptance criteria for AI model performance, human reader improvement studies, ground truth establishment for complex image analysis).

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to physical and biological performance standards for gloves, not the performance of an AI algorithm. Therefore, I cannot fulfill most of the prompt's requests because they are not applicable to the device described in the document.

Here's how the provided information relates to the prompt, and why most points cannot be answered based on this document:

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

The document provides a "Technological Characteristic Comparison Table" (Section 6.0) that lists various physical and chemical properties of the gloves and compares them to the predicate device. These are the "acceptance criteria" for this type of device.

Features & Description	Acceptance Criteria (Predicate Device K120970, based on ASTM D6319-10/21 CFR 800.20/ASTM D6124-06)	Reported Device Performance (Subject Device K181106)
Product name	Powder Free Nitrile Patient Examination Glove, Blue Color	Powder Free Nitrile Patient Examination Gloves, Blue Color
Regulation Number	21 CFR 880.6250	21 CFR 880.6250
Product Code	LZA	LZA
Color	Blue	Blue
Size	Small/ Medium/ Large/X large	Small/ Medium/ Large/X large
Indications for Use	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.
Device Description & Specs	Meets ASTM D6319-10	Meets ASTM D6319-10
Dimensions -- Length (ILS-2 AQL4.0)	Meets ASTM D6319-10; ≥230mm min.	232 mm min for all sizes
Dimensions -- Width (ILS-2 AQL4.0)	Meets ASTM D6319-10; Small 70-90 mm, Medium 85-105mm, Large 100-120mm, X large 110-130 mm	Small 76-90 mm, Medium 89-102 mm, Large 108-119mm, X large 115-128 mm
Dimensions -- Thickness (ILS-2 AQL4.0)	Meets ASTM D6319-10; Finger 0.05mm min., Palm 0.05mm min.	Finger 0.08 mm min., Palm 0.08 mm min.
Physical Properties (Before Aging)	Tensile Strength ≥14MPa, Elongation ≥500%	Tensile Strength: 18-25 MPa, Elongation: 550-600%
Physical Properties (After Aging)	Tensile Strength ≥14MPa, Elongation ≥400%	Tensile Strength: 17-22 MPa, Elongation: 450-570%
Freedom from Pinholes	Meets 21 CFR 800.20, ASTM D6319-10; Inspection Level I AQL2.5, Accept/Reject criteria of 10/11; Water leakage test: 5 noncompliance allowed. (Predicate)	1) Inspection Level I AQL2.5, and Accept/Reject criteria of 10/11; 2) Water leakage test: 5 noncompliance is allowed. (Subject)
Residual Powder	Meets ASTM D6124-06 (Reaffirmation 2011); below 2mg of residual powder	Checked on 5pcs sub-samples (N=5). Mean: 0.1mg/pcs
Materials used to fabricate	Nitrile	Nitrile
Single Patient Use	Single Patient Use	Single Patient Use
Biocompatibility	Non-irritant or non-sensitizer (Predicate)	Non-irritant or non-sensitizer; non-cytotoxicity to L-929 cells (Subject)
Labeling	-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

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

Sample Size: The document mentions a specific sample size for "Residual Powder" (5 sub-samples) and implies inspection levels for Length, Width, Thickness, and Pinholes (e.g., ILS-2 AQL 4.0, Inspection Level I AQL 2.5). These refer to standardized statistical sampling plans for quality control in manufacturing, not a clinical "test set" for an algorithm.
Data Provenance: The tests are "non-clinical tests" conducted to verify the device meets acceptance criteria. The manufacturer is JiangSu DongXin Medical Technology Co., Ltd in China. The "data provenance" would be in-house laboratory testing based on specified ASTM and ISO standards. These are prospective quality control tests for manufacturing, not retrospective/prospective clinical data collection.

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)

Not applicable. "Ground truth" in this context refers to the measured physical and chemical properties of the gloves conforming to established standards, not expert interpretations of images or patient outcomes.

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

Not applicable. This is for assessing inter-reader variability in clinical image interpretation, not for glove testing.

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 glove, not an AI-assisted diagnostic tool.

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

Not applicable. No algorithm is involved.

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

The "ground truth" for this device's performance is adherence to established international standards (ASTM D6319-10 for examination gloves, ISO 10993 for biocompatibility, etc.) and direct physical/chemical measurements (e.g., tensile strength, elongation, dimensions, residual powder weight, water leakage). It's based on quantitative and qualitative measurements against predefined physical and biological acceptance criteria outlined in consensus standards.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the machine learning sense.

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

Not applicable. As above, no training set.

In summary, the provided document details the regulatory clearance of medical examination gloves, which are tested against physical and biocompatibility standards, not AI performance metrics.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

January 16, 2019

JiangSu DongXin Medical Technology Co., Ltd % Chu Xiaoan Official Correspondent Beijing Easylink Co., Ltd Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang Beijing, 100021 Cn

Re: K181106

Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: November 27, 2018 Received: December 11, 2018

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 mediation-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,

Clarence W. Murray lii III -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K181106

Device Name

Powder Free Nitrile 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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510(k) Summary

K181106

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92

1.0 Submitter:

Submitter's name :	JiangSu DongXin Medical Technology Co.,Ltd
Submitter's address :	LongJin Road,The Economic Development Zoneof SuCheng,SuQian City,JiangSu Province,223800 China.
Name of contact person :	Deng Yujie
Date of preparation :	2019-01-14

Designated Submission Correspondent

Company's name	Beijing Easy-Link Company
Company 's address	Rm. F302 Bldg., 41, Jing Cheng Ya Ju,Courtyard 6 of Southern Dou Ge Zhuang,Chaoyang District, Beijing 100121, P.R. China
Contact person	Chu Xiaoan

2.0 Name of the Device

Proprietary/Trade name:	Powder Free Nitrile Patient ExaminationGloves, Blue Color
Common Name:	Patient Examination gloves
Classification Name:	Non-powdered Patient examination glove
Device Classification:	I
Regulation Number:	21 CFR 880.6250
Panel:	General Hospital
Product Code:	LZA

3.0 Predicate device

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

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4.0 Device Description:

The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.

5.0 Indications for Use Statement:

Technological Characteristic Comparison Table: 6.0

Features & Description	Predicate Device (K120970)	Subject Device (K181106)	Comparison
Product name	Powder Free Nitrile Patient Examination Glove, Blue Color	Powder Free Nitrile Patient Examination Gloves, Blue Color	Same
Regulation Number	21 CFR 880.6250	21 CFR 880.6250	same
Product Code	LZA	LZA	same
Color	Blue	Blue	same
Size	Small/ Medium/ Large/X large	Small/ Medium/ Large/X large	same
Indications for Use	Powder Free Nitrile Patient Examination Glove, Blue Color 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.	Powder Free Nitrile Patient Examination Gloves, Blue Color 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.	same
Device Description and Specifications	Meets ASTM D6319-10	Meets ASTM D6319-10	same
Dimensions --LengthILS-2 AQL4.0	Meets ASTM D6319-10≥230mm min	232 mm min for all sizes	similar
Dimensions -- WidthIL S-2 AQL4.0	Meets ASTM D6319-10Small 70-90 mmMedium 85-105mmLarge 100-120mmX large 110-130 mm	Small 76-90 mmMedium 89-102 mmLarge 108-119mmX large 115-128 mm	similar
Dimensions --ThicknessIL S-2 AQL4.0	Meets ASTM D6319-10Finger 0.05mm min.Palm 0.05mm min.	Thickness (mm) min.Finger 0.08Palm 0.08	similar

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Physical PropertiesIL S-2AQL4.0		AgingElongation(%)	Before	After	similar
	Meets ASTM D D6319-10		550-600	450-570
	Before aging/after agingTensile Strength≥14MPa	TensileStrength(MPa)	18-25	17-22
	Before agingElongation ≥500%
	After agingElongation ≥400%
Freedom fromPinholesInspection Level IAQL2.5	Meets• 21 CFR 800.20• ASTM D6319-10	1) Inspection Level I AQL2.5,and Accept/Reject criteria of 10/112) Water leakage test: 5 noncompliance is allowed.			similar
Residual Powder	Meets ASTMD 6124-06(Reaffirmation 2011)below 2mg of residualpowder	1) Checked on 5pcs sub-samples (N=5).2) Result as following:Mean: 0.1mg/pcs			similar
Materials used tofabricate the devices	Nitrile	Nitrile			same
Single Patient UseBiocompatibility	Single Patient UseUnder the conditionsof this study, the testarticle was a non-irritant or non-sensitizer	Single Patient UseUnder the conditions ofthis study, the testarticle was a non-irritant or non-sensitizerUnder the conditions ofthis study, the testarticle was non-cytotoxicity to L-929cells.			similar
Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed.	-Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot-Blue color	-Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot-Blue color			same

7.0 Discussion of Non-Clinical Performance Testing

Non-clinical tests were conducted to verify that the proposed device will meet acceptance crtiteria for each test. The test results demonstrated that the proposed device met the

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acceptance criteria found in the following standards below:

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves ASTM D5151-06(Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves. ASTM D6319-10(Reapproved 2015), Standard Specification for Nitrile Examination Gloves for Medical Application.

8.0 Discussion of Clinical and Performance Testing

Clinical testing is not needed for this device.

9.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated 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.