Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) 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.

Device Description

Powder free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

AI/ML Overview

Here's a breakdown of the acceptance criteria and related study information for the device described in the provided 510(k) summary:

This device is a Powder free Vinyl Patient Examination Glove. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, which primarily involves meeting recognized standards for physical properties, safety, and performance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by recognized ASTM standards and FDA regulations for patient examination gloves. The reported device performance states that the device "Meets" these standards.

Characteristic	Acceptance Criteria (Standard)	Reported Device Performance
Dimension	ASTM standard D 5250-06	Meets
Physical Properties	ASTM standard D 5250-06	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 5250-06 and D6124-01	<2mg/glove
Biocompatibility	Primary Skin Irritation in rabbits (ISO10993-10)	Passes (Not a Primary Skin Irritation)
Biocompatibility	Dermal sensitization in the guinea pig (ISO10993-10)	Passes (Not a Dermal sensitization)

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

Sample Size for Test Set: The document does not specify the exact sample sizes used for testing each characteristic (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility). It simply states that the device "Meets" the standards.
Data Provenance: The tests are implied to be conducted by the manufacturer, TANGSHAN KANGJIA GLOVE CO., LTD., which is based in China. The data could be considered internal manufacturer data from China. Whether it's retrospective or prospective is not explicitly stated, but typically these types of tests are conducted prospectively as part of product development and quality control.

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

This type of device (patient examination glove) does not typically involve "experts" establishing a "ground truth" in the way a diagnostic imaging AI algorithm would. The "ground truth" here is defined by objective, measurable criteria specified in ASTM standards and FDA regulations (e.g., a pinhole is present or not, tensile strength is within a range). Therefore, no "experts" in the clinical sense are used to establish ground truth for this device's performance. The "experts" might be the technicians and engineers who perform the standardized tests.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are not applicable to the testing of patient examination gloves. The tests involve objective measurements and pass/fail criteria based on established standards, rather than subjective interpretations that would require multiple reviewers and adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. These studies are typically relevant for diagnostic or screening devices where human readers (e.g., radiologists) interpret cases, and the AI's impact on their performance is evaluated. For a patient examination glove, there is no "reading" involved, and therefore, such a study is not applicable.

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

Yes, in a conceptual sense, a "standalone" assessment was done. The device's performance characteristics (dimension, physical properties, freedom from pinholes, powder residual, biocompatibility) were evaluated directly against the established standards without human intervention in the interpretation of the results beyond performing the standardized test. There is no algorithm, but its physical qualities were tested independently.

7. The Type of Ground Truth Used

The ground truth used is primarily objective, measurable criteria defined by recognized standards (ASTM) and regulatory requirements (21 CFR). For example:

Dimensions: Measured against specified ranges in ASTM D 5250-06.
Physical Properties: Measured against specified tensile strength, elongation, and other properties in ASTM D 5250-06.
Freedom from Pinhole: Assessed via water leak test against AQL (Acceptable Quality Level) in 21 CFR 800.20.
Powder Residual: Measured gravimetrically against the threshold of <2mg/glove.
Biocompatibility: Assessed through standardized animal tests (Primary Skin Irritation in rabbits, Dermal Sensitization in guinea pigs) to determine if irritation or sensitization occurs, according to ISO10993-10 guidelines.

8. The Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or AI models. It is a physical product, and its manufacturing and quality control do not typically involve data-driven model training.

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

As there is no training set for this device in the AI/ML sense, the question of how its ground truth was established is not applicable.

Summary

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K102569

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: ______________________________________________________________________________________________________________________________________________

OCT 2 1 2010

Premarket Notification [510(k)] Summary

[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :

Submitter's name :	TANGSHAN KANGJIA GLOVE CO., LTD.
Submitter's address :	WUDAIZHUANG, LUANNAN COUNTY, TANGSHAN CITY,HEBEI PROVINCE, 063500, CHINA
Phone number :	(86) 315-4169201
Fax number :	(86) 315-4169311
Name of contact person:	Mr. Fred Zhang
Date the summary was prepared:	Aug. 10th, 2010

[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known

Device Name:	Powder free Vinyl Patient Examination Gloves, Colored (Yellow)
Proprietary/Trade name:	Powder Free Vinyl Patient Examination Gloves
Common Name:	Patient examination glove
Classification Name:	Patient examination glove
Device Classification:	I
Regulation Number:	21 CFR 880.6250
Panel:	General Hospital (80)
Product Code:	LYZ

[(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .

Class I* powder free vinyl patient examination gloves , colored (yellow) that meets all of the requirements of ASTM standard D 5250-06.

Predicate device : Powder free Vinyl Patient Examination Gloves(White, Yellow), SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD. K051156 .

[(a)(4)] A description of the device

Device Description : Powder free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

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K12569

[(a)(5)] The summary describes the intended use of the device

Device Intended Use: Powder free Vinyl Patient Examination Gloves, Colored (Yellow) 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)(6)] A summary of the technological characteristics of new device compared to the predicate device.

The powder free vinyl patient examination gloves, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.

Characteristics	Standard	Device performance
Dimension	ASTM standard D 5250-06	Meets
Physical Properties	ASTM standard D 5250-06	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 5250-06and D6124-01	<2mg/glove
Biocompatability	Primary Skin Irritation in rabbits	PassesNot a Primary Skin Irritation
	Dermal sensitization in the guinea pig	PassesNot a Dermal sensitization

[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .

Powder free Vinyl Patient Examination Gloves, Colored (Yellow) meet requirements per ASTM D5250-06, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10.

[(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .

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

[(b)(3)[ The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe,as effective, and performed as well or better than the legally marketed device identified in (a)(3).

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

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

Tangshan Kangjia Glove Company, Limited C/O Mr. Chu Xiaoan Room 1606 Building 1 Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District, Beijing China 100083

OCT 2 1 2010

Re: K102569

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: August 10, 2010

Received: September 7, 2010

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

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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 yours.

Nb for

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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KI02569

INDICATIONS FOR USE

Applicant: TANGSHAN KANGJIA GLOVE CO.,LTD.

OCT 2 1 2010

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

Device Name: Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)

Indications For Use:

Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)_ 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.

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

Over-The-Counter Úse _X_
(21 CFR 801 Subpart C)
(D
Div
Infe

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General HospitalInfection Control, Dental Devices

510(k) Number: K/ 02.569

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.