A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Device Description

Powder free vinyl patient examination gloves, non sterile that meets all of the requirements of ASTM --standard-D-5250-06

AI/ML Overview

This document describes the Xuzhou Full Sun Medical Products Ltd.'s Disposable Powder Free Vinyl Synthetic Examination Glove. This device is a non-sterile, disposable examination glove made of Poly Vinyl Chloride, available in sizes XS, S, M, L, XL. It is intended for medical purposes to prevent contamination between patients and examiners. The device's performance was compared to a predicate device (K963751) and determined to be substantially equivalent based on various tests.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Description	Acceptance Criteria (Standard Met)	Reported Device Performance
Dimension	ASTM D5250-06	Meets ASTM D5250-06
Physical Property	ASTM D5250-06	Meets ASTM D5250-06
Free of Pinhole	ASTM D5151-06 & 21 CFR 800.20	Meets ASTM D5151-06 & 21 CFR 800.20
Residue Powder	ASTM D6124-06	Meets ASTM D6124-06
Primary Skin Irritation	ISO 10993-10	Passes
Dermal Sensitization	ISO 10993-10	Passes

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

The document does not explicitly state the sample sizes used for each specific test (Dimension, Physical Property, Pinhole, Residue Powder, Skin Irritation, Dermal Sensitization). It only mentions that "Tests were conducted following the recommended procedures outlined in the respective consensus."

The data provenance is from China, as the manufacturer is "Xuzhou Full Sun Medical Products Ltd. Bihe Industry Area, Yitang Town Pizhou County, Jiangsu 221316 China". The data appears to be prospective as it refers to tests conducted on "Our Device" to demonstrate its performance against established standards.

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

This type of information is not applicable to this submission. The tests are for physical and biological properties of a medical glove, not for diagnostic accuracy that would require expert-established ground truth. The "ground truth" here is the adherence to established industry standards (ASTM, ISO, CFR) which are objective measurements.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments. For objective tests on a physical device like an examination glove, adjudication is not applicable as the results are based on standardized laboratory procedures and measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI algorithms or diagnostic devices where human readers interpret medical data. The device in question is a physical medical glove.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

A standalone study, generally referring to the performance of an algorithm without human intervention, is not applicable to this device. The device is an examination glove, not an AI algorithm or a diagnostic tool that involves such a performance assessment.

7. The Type of Ground Truth Used

The "ground truth" used in this context is the adherence to established industry standards and regulations. These include:

ASTM D5250-06 (Standard Specification for Vinyl Examination Gloves)
ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves)
21 CFR 800.20 (Puncture Resistance for Medical Gloves)
ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves)
ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)

These standards define the acceptable range or threshold for each performance characteristic.

8. The Sample Size for the Training Set

Not applicable. The device is a physical medical glove and does not involve an "algorithm" or "training set" in the context of AI or machine learning. The term "training set" is typically used for developing AI models.

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

Not applicable. As the device is not an AI algorithm, there is no "training set" or a ground truth established for one. The performance evaluation is based on direct measurement against predefined regulatory and industry standards.

Summary

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XUZHOU FULL SUN MEDICAL PRODUCTS LT

Bihe Industry Area, Yitang Town, Pizhou County

Tel: 886-2-28765218 Fax: 886-2-28765217

510K Summary:

Date of Summary: June 23, 2011

This summary of 510k safety and effectiveness information is being submitted in accordance with requirements of 21CFR 807.92

Submitter & Foreign Manufacture Identification

Xuzhou Full Sun Medical products Ltd. Bihe Industry Area, Yitang Town Pizhou County, Jiangsu 221316 China TEL: 886-2-28765218 FAX: 886-2-28765217 Ms. Hsun-Hui Huang E-mail:xfsmpl@gmail.com

US Agent and Contact Person Elizabeth Deng 5748 Eaglewood Place, Rancho Cucamonga, Ca 91739 TEL: 1-909-4659188 E-Mail: xfsmpl@gmail.com

Device Name: Disposable Powder Free Vinyl Synthetic Examination Glove, Blue Color Proprietary name: Powder Free Vinyl Patient Examination Gloves (or other clients private labeling) Common Name: Patient examination glove Classification Name: Patient examination glove Device Classification: I Regulation Number: 21CFR880.6250 Product Code: LYZ

Predicate Device Information:

K963751 "PT Synthetic Medical Vinyl Patient Examination Gloves, Powder Free" manufactured by "Shanghai PT Plastics Enterprise Company Ltd.

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Device description:

ﺗﺮ

Powder free vinyl patient examination gloves, non sterile that meets all of the requirements of ASTM --standard-D-5250-06----------------------------------------------------------------------------------------------------------------------------------------------------------

Intended Use:

A 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.

Comparison to Predicate Devices:

Powder free vinyl patient examination gloves, non sterile are compared with the following Predicate Devices in terms of intended use, design, material, specifications and performance.

K963751 "PT Synthetic Medical Vinyl Patient Examination Gloves, Powder Free" manufactured by "Shanghai PT Plastics Enterprise Company Ltd.

The following table shows similarities and differences of use, design, and material between our device and the predicate devices:

Description	Our Device	Predicate Device (K96371)
Indication for use	Disposable device intended for medical purposesthat is worn on the examiner's hand or finger toprevent contamination between patient andexaminer	Same
Basic Design	Gloves have separate sheaths or openings for eachfinger and the thumb	Same
Materials	Poly Vinyl Chloride	Same
Size	XS,S,M,L,XL	Same
Single Use	Yes	Yes
Sterile	Non sterile	Non sterile

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. The following table shows similarities and differences of the performance between our device and the predicate devices. Tests were conducted following the recommended procedures outlined in the respective consensus, and results for Powder Free Vinyl Patient Examination Gloves (or other clients private labeling); manufactured by XUZHOU-FULL SUN-MEDICAL-PRODUCTS-LTD.metall relevant requirements in the test standards, and are comparable to the predicate device.

Description	Our Device	Predicate Device (K96371)
Dimension	Meets ASTM D5250-06	Meets
Physical Property	Meets ASTM D5250-06	Meets
Free of Pinhole	Meets ASTM D5151-06Meets 21 CFR 800.20	Meets
Residue Powder	Meets ASTM D6124-06	Meets
Primary SkinIrritation(ISO 10993-10)	Passes	Passes
DermalSensitization(ISO 10993-10)	Passes	Passes

Substantial Equivalent Conclusions

Based on the comparison of intended use, design, materials, and performance, our vinyl disposable examination gloves powder free are substantial equivalent to its predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of three human figures connected at the shoulders.

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

Xuzhou Full Sun Medical Products Limited C/O Ms. Elizabeth Deng 5748 Eaglewood Place Rancho Cucamonga, California 91739

JUL 1 4 2011

Re: K111240

Trade/Device Name: Disposable Powder Free Vinyl Synthetic Examination Glove Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 23, 2011 Received: June 28, 2011

· Dear Ms. Deng:

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 - Ms. Deng

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 (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/Ab outFDA/CentersOffices/CDRH/C DRHOffices/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/R cportaProblem/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.

Anthony D. Watson
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:	XUZHOU FULL SUN MEDICAL PRODUCTS LTD.
510(k) Number (if known):	K111240
Device Name:	Disposable Powder Free Vinyl Synthetic Examination Glove
	Blue Color
Indications for Use:	A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Prescription Use(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use X(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

and the comments of the contribution of the comments of the subscribed

Cakil Ganguly
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111240

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.