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 5250-0004

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

The provided document is a 510(k) Premarket Notification summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". It describes the device and its compliance with relevant standards rather than a study for an AI/ML powered device. Therefore, many of the requested fields for AI/ML device studies are not applicable.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Dimension (ASTM D 5250-00e4)	Meets
Physical Properties (ASTM D 5250-00e4)	Meets
Freedom from pinholes (21 CFR 800.20)	Meets
Powder Residual (ASTM D 5250-00e4 and D6124-01)	< 2mg/glove
Biocompatibility: Primary Skin Irritation (rabbits)	Passes (Not a Primary Skin Irritation)
Biocompatibility: Dermal sensitization (guinea pig)	Passes (Not a Dermal sensitization)

Study Details (as applicable for a non-AI/ML device)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. For "Powder Residual", a quantity is measured per glove, implying testing on multiple gloves, but the sample size isn't given. For "Freedom from pinholes", it refers to 21 CFR 800.20, which likely specifies an AQL (Acceptable Quality Limit) sampling plan, but the specific sample size used is not provided. For biocompatibility, animal models were used (rabbits for skin irritation, guinea pigs for sensitization), but the number of animals is not specified.
- Data Provenance: Not explicitly stated, but the tests performed are standard industrial tests for medical devices. The manufacturer is WUXI SHENZHOU PLASTIC PRODUCTS CO.,LTD in P.R.CHINA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. These are physical and biological material property tests based on standardized methods, not expert interpretation of data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Results are quantitative measurements or direct observations against a standard (e.g., "Passes," "Meets," or a specific numerical threshold like "<2mg/glove").
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 not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For physical properties (Dimension, Physical Properties, Freedom from pinholes, Powder Residual), the "ground truth" is defined by the technical specifications and thresholds set in the referenced ASTM standards (D5250-00e4, D6124-01) and regulatory requirements (21 CFR 800.20).
- For Biocompatibility, the "ground truth" is based on the biological response observed in animal models (rabbits for primary skin irritation, guinea pigs for dermal sensitization) according to the test protocols, confirming the absence of significant irritation or sensitization. The reference ISO10993-10 also points to standardized biological evaluation methods.
The sample size for the training set:
- Not applicable. This is not an AI/ML device, and thus there is no training set in the context of machine learning. The device is manufactured and tested according to established quality control procedures.
How the ground truth for the training set was established:
- Not applicable. As this is not an AI/ML device, there is no "training set ground truth." The ground truth for device performance is based on adherence to pre-defined industry standards and regulatory requirements.

Summary

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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: K020149 ." (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 :	WUXI SHENZHOU PLASTIC PRODUCTS CO.,LTD
Submitter's address :	Caomutang, Houqiao Town, Wuxi City,Jiangsu Province, P.R.China, 214106
Phone number :	(86) 510 88725811
Fax number :	(86) 510 88727280
Name of contact person:	Mr. Ping An
Date the summary was prepared:	Jan.02.2007

[(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 5250-00t4

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 5250-0004

[(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 5250-00e4and D6124-01	<2mg/glove
Biocompatability	Primary Skin Irritation in rabbits	PassesNot 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 D5250-00-4, 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 waterleak test on pinhole AQL., meet labeling claims .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is black and white, and the text is in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wuxi Shenzhou Plastic Products Company Limited C/O Mr. Chu Xiaoan Beijing Easy-Link Company Room 1606, Building 1, Jianx Yuan No. 209 Bei Si Huan Zhong Road Haidian District. Beijing 100083 P.R. CHINA

FEB 2 3 2007

Re: K070149

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: January 2, 2007 Received: January 16, 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 (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 (240) 276-3150 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:WUXI SHENZHOU PLASTIC PRODUCTS CO.,LTD

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)

Shule A. Murphy K.

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.