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 5250-0064

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the requested format.

It's important to note that this document is a 510(k) summary for a general medical device (patient examination gloves). As such, the "study" referred to is primarily non-clinical testing against established standards, not a clinical trial in the way one might think of it for drug development or complex diagnostic AI. The questions provided in the prompt are more geared towards AI/software as a medical device (SaMD) evaluations, so some sections will reflect that the information is not directly applicable or available in this type of submission.

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 5250-00e4	Meets
Physical Properties	ASTM standard D 5250-00e4	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 5250-00e4 and D6124-01	<2mg/glove
Biocompatibility (Primary Skin Irritation)	ISO10993-10 (via reference in (b)(1))	Passes
Biocompatibility (Dermal Sensitization)	ISO10993-10 (via reference in (b)(1))	Passes

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

The document does not specify the exact sample sizes used for each test. The provenance is not explicitly stated as 'country of origin of data,' but the testing standards (ASTM, FDA CFR, ISO) are international/US standards. This is non-clinical performance testing.

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)

Not applicable. Ground truth for these physical and chemical tests is established by adhering to the methodologies described in the cited ASTM, 21 CFR, and ISO standards by qualified testers, rather than expert consensus on images or diagnoses.

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

Not applicable. This is not a human-adjudicated test set; it involves objective measurements against established technical standards.

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

Not applicable. This is a physical medical device (gloves), not an AI/software device. There is no concept of "human readers" or "AI assistance" in this context.

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

Not applicable. This is a physical medical device (gloves), not an AI/software device.

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

The ground truth used is based on established, objective measurement methods defined in international and US standards (ASTM D5250-00e4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10) for physical properties, chemical residue, and biocompatibility.

8. The sample size for the training set

Not applicable. This is a physical medical device. There is no "training set" in the context of an algorithm or AI. Product development and manufacturing would involve quality control and process validation, but this is distinct from an AI training set.

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

Not applicable, as there is no training set for a physical medical device like this.

Summary

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C Summary

FEB - 7 2005

"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: K05 0 34 ." (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:	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 5250-0064.

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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064

[(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 band or 'inger 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 inrabbits	Passes
	Dermal sensitization in theguinea pig	Passes

[(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 D5250-006, 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 Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for watericak test on pinhole AQL, meet labeling claims .

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Indications for Use

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

510(k) Number (if known): K050154

Device Name: _ Powder Free Vinyl Patient Examination Gloves, White (Non-colored)

Indications For Use:

Powder free vinyl patient examination glove is a disposable device intended for medical purposes I owder rece miner'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 _________________________________________________________________________________________________________________________________________________________ (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)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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Image /page/3/Picture/1 description: The image is a circular seal or logo. The seal contains the emblem of the U.S. Department of Health & Human Services (HHS) in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the emblem in a circular fashion.

FEB - 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zibo Zhuangyuan Plastic & Rubber 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 100022

Re: K050154

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: January 9, 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 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 your 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 yours,

Cuts
Chiu-Ling, 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): K050154

Device Name: _ Powder Free Vinyl Patient Examination Gloves, White (Non-colored)

Indications For Use:

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.

ZIBO ZHUANGYUAN PLASTIC & RUBBER CO.,LTD

YANG Yanhong

CHAIRMAN OF BOAR 7180

李

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)

Cittic Proku Joneice Mashwood

Tivisio · Sian-Off) 1 Anesthesiology, General Hospital, 1950 Control, Dental Dental Devices

Number: K050154

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.