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

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Zibo Hongye Shangqin Plastic & Rubber Co., Ltd. Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored), based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Dimension	Meets ASTM standard D 5250-00e4.
Physical Properties	Meets ASTM standard D 5250-00e4.
Freedom from pinholes	Meets 21 CFR 800.20 (waterleak test on pinhole AQL)
Powder Residual	Meets ASTM standard D 5250-00e4, <2mg/glove
Biocompatibility - Primary Skin Irritation	Passes (Not a Primary Skin Irritation)
Biocompatibility - Dermal Sensitization	Passes (Not a Dermal Sensitization)

Study Details

This device is a Class I medical device (patient examination glove), and the submission primarily relies on non-clinical testing to demonstrate substantial equivalence to a predicate device (FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, K032908). Clinical data was explicitly stated as not needed for this type of device.

Here's a breakdown of the study information based on the provided text:

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes used for the non-clinical tests (Dimension, Physical Properties, Freedom from pinholes, Powder Residual, Biocompatibility).
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the tests were retrospective or prospective. Given that the manufacturer is based in China, it's highly probable the testing was conducted there, directly by or on behalf of the manufacturer, and would be considered prospective for the purpose of this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the "ground truth" for these performance criteria is established through objective laboratory testing against established material standards (ASTM, CFR). It does not involve expert interpretation or consensus in the typical sense of a clinical diagnostic study.
Adjudication method for the test set:
- Not applicable. As the "ground truth" is based on objective laboratory testing against material standards, there is no need for expert adjudication.
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 device is a patient examination glove and does not involve AI or human interpretation of medical images/data in a diagnostic context.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical medical product (glove), not an algorithm or software.
The type of ground truth used:
- The "ground truth" (or reference standard) is based on established industry standards and regulations:
  - ASTM standard D 5250-00e4 (for Dimension, Physical Properties, Powder Residual)
  - 21 CFR 800.20 (for Freedom from pinholes/waterleak test AQL)
  - ISO10993-10 (for Biocompatibility, specifically Primary Skin Irritation and Dermal Sensitization)
  - ASTM D6124-01 (also related to powder residual or other physical properties)
The sample size for the training set:
- Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As no training set was used, no ground truth needed to be established for it.

Summary

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Summary

K072085

"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: ______________________________________________________________________________________________________________________________________________

Premarket Notification [510(k)| Summary

SEP - 4 2007

[(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 HONGYE SHANGQIN PLASTIC & RUBBER CO.,LTD.
Submitter's address :	THE DEVELOPING TECHNICAL DISTRICT IN CROSS OFJIQING AND ZHANGTIAN EXPRESSWAY, ZIBO, 255000,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:	Jul.10.2007

[(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, 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 5250-0064.

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

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

Device Intended Use: powder free vinyl patient examination glove, Clear(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	PassesNot 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 , Clear(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 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 4 2007

Mr. Chu Xiaoan Official Correspondent Zibo Hongye Shangqin Plastic & Rubber Products Company, Limited Room 1606 Building 1. Jianxiang Yuan, No. 209 Bei Si Huan Zhong Road Haidian District, Beijing 10083 P.R. CHINA

Re: K072085

Trade/Device Name: 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: July 10, 2007 Received: July 30, 2007

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.

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 - 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 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 (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) 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.

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 HONGYE SHANGQIN PLASTIC & RUBBER CO.,LTD.

KOJ2085 510(k) Number (if known):_*

Device Name: Powder Free Vinyl Patient Examination Gloves, Clear(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.

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)

Shila A. Murphy, MD

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Revises Infection Control, Dental Devices

510(k) Number: K02085

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.