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

Powder Free Nitrile Patient Examination Gloves,Blue Color are disposable device which made of nitrile synthetic rubber , intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 6319 00a (2005)e1.

AI/ML Overview

The provided document describes the acceptance criteria and the study conducted for the "Powder Free Nitrile Patient Examination Gloves, Blue Color." This is a medical device, and the evaluation focuses on its physical and biological properties.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Characteristics	Standard (Acceptance Criteria)	Device Performance
Dimension	ASTM standard D 6319 00a (2005)e1.	Meets
Physical Properties	ASTM standard D 6319 00a (2005)e1.	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 6319 00a (2005)e1. and D6124-06	Meets (<2mg/glove)
Biocompatibility	Primary Skin Irritation in rabbits (ISO 10993-10)Dermal sensitization in the guinea pig (ISO 10993-10)	PassesNot a Primary Skin IrritationPassesNot a Dermal sensitization

2. Sample sized 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 of the tests. It states that "The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above," referring to the standards. This implies that the tests were conducted according to the sampling requirements within those ASTM and ISO standards and 21 CFR regulations.

The submitter's address is "JiangSu DongLing Plastic & Rubber Co.,Ltd, DongWu Road, Economic Development Zone, SuQian, JiangSu Province, 223800, China," indicating the data provenance is likely China. The study appears to be prospective for the device being submitted, as it involves testing the specific product for its 510(k) 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 is a physical and biocompatibility testing of a medical glove, not a diagnostic device requiring expert interpretation of images or other data to establish ground truth. Therefore, the concept of "experts" in the context of image or data interpretation to establish ground truth does not apply to this device. The "ground truth" is established by the direct measurement against objective standards (e.g., tensile strength, elongation, water leak test for pinholes, chemical analysis for powder, and animal studies for biocompatibility).

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

Given the nature of the device and testing, an adjudication method for a test set (like for ground truth establishment in diagnostic studies) is not applicable. The tests performed are objective measurements against defined 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists analyzing medical images with and without AI assistance). The device in question is a medical glove, which does not involve human readers interpreting data.

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

No, a standalone study (in the context of an algorithm's performance without human-in-the-loop) was not done. This type of study is relevant for AI/ML-based diagnostic algorithms. The performance of the glove is evaluated through physical, chemical, and biological tests, not through an algorithm.

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

The ground truth for this device is based on objective measurement against established ASTM and ISO standards and FDA regulations. Examples include:

Physical measurements: Verifying dimensions, tensile strength, and elongation meet the specified ranges.
Chemical analysis: Measuring powder residual to ensure it's below the threshold.
Leak testing: (Freedom from pinholes) through water leak tests as per 21 CFR 800.20.
Biocompatibility testing: Animal studies (rabbits for primary skin irritation, guinea pigs for dermal sensitization) as per ISO 10993-10 standards.

8. The sample size for the training set

Not Applicable. This device is a manufactured product (medical glove), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process is controlled to ensure consistent product quality.

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

Not Applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for a training set does not apply.

Summary

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Section C (rev.02)510(k) Summary (21 CFR 807.92)

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: K 110247

Premarket Notification [510(k)] Summary

Submitter's name :

JiangSu DongLing Plastic & Rubber Co.,Ltd

DongWu Road, Economic Development Zone,

SuQian,JiangSu Province, 223800,China

Submitter's address :

Name of contact person:

Proprietary/Trade name:

Phone number :

Fax number :

Mr.ZhiJun Xu

0086-527-82860080

Dec.24, 2010 Date the summary was prepared:

Device Name:

Powder Free Nitrile Patient Examination Gloves,Blue Color

Powder Free Nitrile Patient Examination Gloves, Blue Color clients private labeling Other

Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:

Exam gloves Patient examination glove 21 CFR 880.6250 General Hospital (80) LZA

Class 1* Powder Free Nitrile Patient Examination Gloves,Blue Color that meets all of the requirements of ASTM D 6319 00a(2005)e1.

Predicate device: POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. K082598.

Device Description: Powder Free Nitrile Patient Examination Gloves,Blue Color are disposable device which made of nitrile synthetic rubber , intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 6319 00a (2005)e1.

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Device Intended Use (indication for use): Powder Free Nitrile Patient Examination Device Intended 'Use (Indication' for use). Towardical purposes that is worn on the Gloves,Blue Color is a disposable device intended for then patient and examiner.

A summary of the technological characteristics of new device compared to the predicate device.

The Powder Free Nitrile Patient Examination Gloves,Blue Color, non sterile are summarized The Powder Free Nitrile Patient Exammation Croves,Bhile Colors, Mor equivalent standard.

Characteristics	Standard	Device performance
Dimension	ASTM standard D 6319 00a (2005)el.	Meets
Physical Properties	ASTM standard D 6319 00a (2005)el.	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 6319 00a (2005)el.and D6124-06	Meets<2mg/glove
Biocompatability	Primary Skin Irritation in rabbitsISO 10993-10Dermal sensitization in the guinea pigISO 10993-10	PassesNot a Primary Skin IrritationPassesNot a Dermal sensitization

A brief discussion of the nonclinical submitted, reference, or relied on in the premarket A brief discussion of the or a determination of substantial equivalence _

Powder Free Nitrile Patient Examination Gloves,Blue Color, meet requirements per ASTM
Portal Property on Organise One SER 10002 10: 2007/4md 11 Powder Free Nitrile Patient Exammation Oloves,Diae Color, Most Squares 2006.

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

A brief discussion of the clinical submitted, reference, or relied on in the premarket A brief discussion of the Chilection of substantial equivalence .

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

Conclusions

....

Conclusions
It can be concluded that the Powder Free Nitrile Patient Examination Gloves and pinhology A Ol It can be concluded that the Powder Free Nithic Fatent Bhanniation and FDA is and the AQL..
ASTM standard or equivalent standard and FDA requirements for waterleak test on pi meet labeling claims.

It can be concluded that the Powder Free Nitrile Patient Examination Gloves,Blue Color is as safe, as effective, and performs as well as the predicate device, POWDER FREE BLUE safe, as effective, and performs as well as the predicate as now be and of the county of the GROUP CO., LTD., K082598

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and is smaller than the eagle symbol.

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

Jiangsu Dongling Plastic Rubber Company, Limited C/O Mr. Chu Xiaoan Beijing Easy-Link Co. Ltd. Room 1606 Bldg 1 Yuan #209 Bei Si Huan Zhong Road Beijing, PR China 100083

JUN 1 0 2011

Re: K110247

Trade/Device Name: Powder Free Nitrile Patient Examination Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: May 26, 2011 Received: May 26, 2011

Dear Mr. 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.

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Page 2- Mr. Xiaoan

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 (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Anthem Vam

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

Enclosure

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INDICATIONS FOR USE

JiangSu DongLing Plastic & Rubber Co.,Ltd Applicant:

KI10247 510(k) Number (if known): *

Powder Free Nitrile Patient Examination Gloves,Blue Color Device Name:

Indications For Use:

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Claverie-Williams

Jivision Sign-Off) ivision of Anesthesiology, General Hospital fection Control, Dental Devices

510(k) Number: K110247

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.