Powder free vinyl patient examination glove 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 vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

AI/ML Overview

The provided text describes the acceptance criteria and performance of a Non-sterile Powder Free Vinyl Patient Examination Gloves, Clear(non-colored) and the study that proves it meets those criteria.

Acceptance Criteria and Device Performance

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

Characteristics	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 D6124-06	<2mg/glove
Biocompatibility:
* Primary Skin Irritation	Primary Skin Irritation in rabbits	Passes (Not a Primary Skin Irritation)
* Dermal Sensitization	Dermal sensitization in the guinea pig	Passes (Not a Dermal sensitization)

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

Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of the number of gloves tested for each characteristic. It refers to meeting the requirements of the standards (e.g., ASTM D 5250-06, 21 CFR 800.20, ISO10993-10), which would imply testing a sufficient number of samples as prescribed by those standards.
Data Provenance: The studies were conducted to support a 510(k) submission from WANGDA PLASTIC CO., LTD, located in Kaifeng City, Henan, China. Therefore, the data likely originated from testing performed by or for this Chinese manufacturer. The studies are prospective in the sense that they were designed and executed to demonstrate compliance with specific standards for this device.

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 to this type of device and study. The "ground truth" for glove performance is established by objective, standardized tests and measurements against pre-defined physical and chemical properties and biological responses, not by expert interpretation like in image analysis or clinical diagnosis. Biocompatibility tests (skin irritation, dermal sensitization) would be performed by qualified toxicologists or similar experts, but the document does not specify their number or qualifications beyond stating the tests were performed on rabbits and guinea pigs.

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

This information is not applicable for this type of device. The evaluation of glove performance characteristics (dimensions, physical properties, pinholes, powder residual, biocompatibility) relies on objective measurement and observation against established thresholds within the specified standards, not subjective interpretation requiring an adjudication process.

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 diagnostic devices that involve human interpretation of images or data, often with AI assistance. It is not applicable to the evaluation of physical and biocompatibility properties of examination gloves.

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

Not applicable. This device is a physical product (examination gloves), not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here.

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

The "ground truth" for this device is based on objective, quantitative measurements and qualitative observations against the specifications set forth in recognized international standards and regulations. These include:
- Dimensional measurements: Length, width, thickness as per ASTM standard D 5250-06.
- Physical properties testing: Tensile strength, elongation at break as per ASTM standard D 5250-06.
- Water leak test: To determine freedom from pinholes as per 21 CFR 800.20.
- Powder residual measurement: As per ASTM D 5250-06 and D6124-06.
- Biocompatibility assays: Observing biological responses (skin irritation, dermal sensitization) in animal models as per ISO10993-10 principles (implied by the tests performed).

8. The sample size for the training set:

This information is not applicable. This device is not an AI/ML algorithm that requires a "training set." The performance evaluation relies on testing physical samples against pre-defined standards.

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

This information is not applicable for the reason stated in point 8.

Summary

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Attachment.

110944

1 2011

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: ______________________________________________________________________________________________________________________________________________ ." (applicant leave blank)

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 :	WANGDA PLASTIC CO., LTD
Submitter's address :	#129, BINHE EAST RD. KAIFENG CITY, HENAN,475000, CHINA
Phone number :	(86) 378-2924343
Fax number :	(86) 378-2924348
Name of contact person:	Mr. Cao Hui
Date the summary was prepared:	April 2nd, 2011

[(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:	Non-sterile Powder Free Vinyl Patient Examination Gloves,Clear(non-colored)
Proprietary/Trade name:	Powder Free Vinyl Patient Examination GlovesOther clients private labeling
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 , Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .

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

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Device Description : powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

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

Device Intended Use:Non-sterile powder free vinyl patient examination glove. Clear (noncolored) 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 D6124-06	<2mg/glove
Biocompatability	Primary Skin Irritation inrabbits	PassesNot a Primary Skin Irritation
	Dermal sensitization in theguinea pig	PassesNot a Dermal sensitization

[(b)(1)] A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses,

Powder free vinyl patient examination gloves , Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10. , it is safe and effective, and it's performance meets the requirements of its pre-defined acceptance criteria and intended uses.

[(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 and clinical 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 , Clear(non-colored) meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL, meet labeling claims . It is as safe,as effective, and performed as well the legally marketed device identified in (a)(3).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of a human figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

WANGDA PLASTIC 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

2011

Re: K110944

Trade/Device Name: Non-Sterile Powder-Free Vinyl Patient Examination Gloves, Clear (Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: August 12, 2011 Received: August 12, 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 licderal 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Y fhutthin 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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INDICATIONS FOR USE

Applicant: WANGDA PLASTIC CO., LTD

510(k) Number (if known): * K / 1 0 9 4 4

Device Name:

NON-STERILE POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)

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)

Shabe A Must Cli
(Division Sign Oke

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K110944

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.