This powder free vinyl 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.

Device Description

powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4.

AI/ML Overview

Requested information about the acceptance criteria and study that proves the device meets the acceptance criteria:

Table of acceptance criteria and the reported device performance:

Characteristics	Acceptance Criteria (Standard)	Device Performance
Dimension	ASTM standard D 5250-00e4	Meets
Physical Properties	ASTM standard D 5250-00e4	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 5250-00e4 & D6124-01	<2mg/glove
Biocompatibility:
- Primary Skin Irritation	(ISO10993-10 mentioned implicitly)	Passes (Not a Primary Skin Irritation, tested in rabbits)
- Dermal Sensitization	(ISO10993-10 mentioned implicitly)	Passes (Not a Dermal sensitization, tested in the guinea pig)

Sample size used for the test set and the data provenance: Not applicable. This document pertains to patient examination gloves, which undergo non-clinical testing rather than classification with a "test set" in the context of AI/ML or medical imaging devices. The tests are performed on samples of the manufactured gloves. The document does not specify exact sample sizes for each test but refers to standard testing methods. The data provenance is derived from direct testing of the manufactured gloves.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For medical device manufacturing like gloves, "ground truth" is established by adherence to specified physical, chemical, and biological standards (e.g., ASTM, CFR). No human experts are used to subjectively determine a "ground truth" for the test set in the way they would for diagnostic imaging.
Adjudication method for the test set: Not applicable. Since the evaluation relies on objective measurements against predefined standards, no subjective adjudication method (like 2+1 or 3+1 consensus) is required.
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 patient examination glove, not an AI or diagnostic imaging device. Therefore, MRMC studies and AI assistance are irrelevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
The type of ground truth used: The ground truth is defined by objective, quantitative, and qualitative criteria established in international and national standards (ASTM standard D 5250-00e4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10). These standards specify acceptable ranges for dimensions, physical properties, limits for pinholes, maximum powder residual, and biological response criteria for biocompatibility tests.
The sample size for the training set: Not applicable. There is no "training set" in the context of manufacturing and testing patient examination gloves.
How the ground truth for the training set was established: Not applicable. There is no "training set" for this type of device. The established standards are the "ground truth" against which all manufactured gloves are evaluated.

Summary

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C 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: 1003415 " (applicant leave blank)

Premarket Notification [510(k)] Summary

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

Submitter's name :	SHIJIAZHUANG WINFUL PLASTIC CO.,LTD
Submitter's address :	NO.6 CANGSHI ROAD, JINZHOU CITY,HEBEI, 052260,P.R. China
Phone number :	(86)-311-4320503
Fax number :	(86)-311-4336614
Name of contact person:	Mr. Yin Mingfei
Date the summary was prepared:	Dec.06.2004

(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, white(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 , white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

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

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

Device Description : powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4.

Section C Page 1of 2

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

Device Intended Use: powder free vinyl patient examination glove, white(non-colored) 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 5250-00e4	Meets
Physical Properties	ASTM standard D 5250-00e4	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 5250-00e4	Meets
Biocompatability	and D6124-01	<2mg/glove
	Primary Skin Irritation in rabbits	Passes
		Not a Primary Skin Irritation
	Dermal sensitization in the guinea pig	Passes
		Not 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 , white(non-colored) meet requirements per ASTM D5250-004, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10.

[(b)(2)] A brief discussion of the clinical submitted, reference, or refied 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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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the perimeter of the circle.

FEB - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shijiazhuang Winful Plastic Company Limited C/O Ms. Chen Yuhong TUV Rheinland Beijing Office Unit 707, AVIC Building, No. 10B Central Road, East 3rd Ring Road, Chaoyang District, Beijing, P.R. CHINA 10002

Re: K043475

Trade/Device Name: Powder-Free Vinyl Patient Examination Gloves, White (Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 13, 2004 Received: December 16, 2004

Dear Ms. Yuhong:

We have reviewed your Section 510(k) premarket notification of intent to market the device we mayor 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to arrivand Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provized for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 MA), it may of subject to back adalof Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in firsher announcements concerning your device in the Federal Register.

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Page 2 - Ms. Yuhong

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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

510(k) Number (if known):_K043475

Device Name: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)

Indications For Use: This powder free vinyl 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.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Di for Walter Richard, (Walter Biondi
(Red) 2/1/95

เติมารถก Sen-Call ( . Wision of Anesthesiology, General Hospital, Infection Control, Dental Devic

510(k) Number

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.