Powdered 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

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0004

AI/ML Overview

The provided document describes the safety and effectiveness information for "Powdered Vinyl Patient Examination Gloves, White (Non-colored)" submitted by ZIBO ZHUANGYUAN PLASTIC & RUBBER CO.,LTD. The study presented is a non-clinical evaluation comparing the device's technical characteristics against established standards.

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristics	Standard	Acceptance Criteria	Reported Device Performance
Dimension	ASTM standard D 5250-00e4	Meets ASTM standard D 5250-00e4 requirements	Meets
Physical Properties	ASTM standard D 5250-00e4	Meets ASTM standard D 5250-00e4 requirements	Meets
Freedom from pinholes	21 CFR 800.20	Meets 21 CFR 800.20 requirements (implying a specific AQL for waterleak test)	Meets
Powder Amount	ASTM standard D 5250-00e4	<10mg/dm2 (as indicated by the "Device performance" column for Biocompatability/Powder Amount)	Meets (<10mg/dm2 is explicitly stated in the performance section, which is then followed by "Passes" for both a skin irritation and sensitization test)
Biocompatibility	Primary Skin Irritation in rabbits	Not a Primary Skin Irritation (implicitly defined by passing the test)	Passes
	Dermal sensitization in the guinea pig	Not a Dermal sensitization (implicitly defined by passing the test)	Passes

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

Sample Size: The document does not explicitly state the specific sample size for each characteristic test (e.g., how many gloves were tested for dimensions, pinholes, etc.). It generally refers to meeting the requirements "per ASTM D5250-00", "per ASTM D6124-01", "per 21 CFR 800.20", and "ISO10993-10". These standards would define the required sample sizes for such tests.
Data Provenance: The data is presented as a summary of non-clinical tests performed by the manufacturer, ZIBO ZHUANGYUAN PLASTIC & RUBBER CO.,LTD, located in China. The testing appears to be retrospective in nature, as it's a submission for regulatory review based on already conducted tests. The country of origin of the data is P.R.CHINA.

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

This device is a Class I medical device (patient examination gloves). The "ground truth" for its performance is established by adherence to recognized industry standards (ASTM, FDA regulations, ISO) rather than expert consensus on individual cases.
Therefore, there were no specific "experts" in the sense of medical professionals diagnosing conditions being used to establish a ground truth for individual items in the test set. The ground truth is the standard's specification itself, and the testing laboratories or personnel would be qualified to perform the tests according to those standards.

4. Adjudication Method for the Test Set:

Not applicable in the context of this device and study. The evaluation focuses on meeting predefined specifications from industrial standards, not on subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret images or data, and AI assistance is being evaluated. Patient examination gloves do not involve human readers interpreting data in this manner.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, in spirit, the study is standalone. The device itself (the glove) is evaluated against objective, measurable criteria defined by standards. There is no "algorithm" in a software sense, but the device's physical and biological properties are assessed in a standalone manner without human intervention influencing the outcome of the measurement beyond the testing procedure itself. The performance "meets" or "passes" the specified criteria.

7. The Type of Ground Truth Used:

The ground truth used is primarily objective, established performance criteria and requirements defined by 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, pinhole rates, powder amount, and biocompatibility outcomes.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device being tested against established standards, not a machine learning algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device evaluation.

Summary

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FEE = 7 2005

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: K050155 ." (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 :	ZIBO ZHUANGYUAN PLASTIC & RUBBER CO.,LTD
Submitter's address :	THE DEVELOPING TECHNICAL DISTRICT IS IN THECROSS OF JIQING AND ZHANGTIAN EXPRESSWAY,ZIBO CITY,SHANDONG PROVINCE, 255087, P.R.CHINA
Phone number :	(86) 533-3811696
Fax number :	(86) 533-3811696
Name of contact person:	Ms. GENG Xiaocong
Date the summary was prepared:	9 January 2005

[(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:	Powdered Vinyl Patient Examination Gloves,White (Non-colored)
Proprietary/Trade name:	Powdered 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* powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4.

Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032907.

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

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Device Description : powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0004

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

Device Intended Use: powdered 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 powdered vinyl patient examination gloves, white (non-colored) non sterile are summarized with the following technological characteristics compared no 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 Amount	ASTM standard D 5250-00e4	Meets
Biocompatability	Primary Skin Irritation in rabbits	<10mg/dm2Passes
	Dermal sensitization in the guinea pig	Not a Primary Skin IrritationPassesNot 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 .

Powdered vinyl patient examination gloves , white(non-colored) meet requirements per ASTM D5250-00", 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 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 Powdered Vinyl Patient Examination Gloves, White(non-colored) meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL, meet labeling claims .

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.

FEB - 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ZIBO Zhuangyuan Plastic & Rubber Company Limited C/O Ms. Chen Yuhong Official Correspondent TUV Rheinland Beijing Office Unit 707, Avic Building, No. 10B Central Road, East 3rd Ring Road, Chaoyang District, Beijing 100022, P.R. CHINA

Re: K050155

Trade/Device Name: Powdered Vinyl Patient Examination Gloves, White (Non-Colored) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: January 10, 2005 Received: January 24, 2005

Dear Ms. Yuhong:

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.

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 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. 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 nfour any Federal statutes and regulations administered by other Federal agencies. or the For of any 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 and instills (= = = = = = 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) ring relet 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 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), rr you dosite 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 maj Souall 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 yours,

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

Applicant: ZIBO ZHUANGYUAN PLASTIC & RUBBER CO., LTD.

510(k) Number (if known): K050155

Device Name: Powdered Vinyl Patient Examination Gloves, White (Non-colored)

Indications For Use:

Powdered 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.

ZIBO ZHUANGYUAN PLASTIC & RUBBER CO.,LTD

YANG Yanhong

CHAIRMAN OF BOAL

2100

林孝苏

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)

Patrica A. Fox, Jennette Michaud, @Ewing, Bangit 2/7/05

Sign-Off
physiology, General Hospital,
Dental Devices

Number. K 050155

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.