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, yellow) that meets all of the requirements of ASTM standard D 5250-0084.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is stated and noting areas where the information is not present:

Acceptance Criteria and 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	<2mg/glove
Biocompatability - Primary Skin Irritation in rabbits	ISO10993-10	Passes (Not a Primary Skin Irritation)
Biocompatability - Dermal sensitization in the guinea pig	ISO10993-10	Passes (Not a Dermal sensitization)

Study Information

Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated. The document refers to meeting standards (ASTM, FDA) which would imply a defined sample size within those standards, but the specific quantity tested for each characteristic is not provided in this summary.
- Data provenance: Not explicitly stated. The studies are non-clinical, likely conducted by the manufacturer or a third-party lab to demonstrate compliance with the referenced ASTM and ISO standards. The country of origin for the data (beyond the manufacturer's location in China) is not mentioned. It can be inferred that these are prospective tests performed on the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not stated. For this type of device (patient examination gloves) and the tests conducted (physical and biocompatibility), "experts" in the sense of clinical reviewers establishing ground truth is not typically relevant. The ground truth for these tests is defined by the objective measurement criteria within the ASTM and ISO standards (e.g., maximum allowable pinholes, specific tensile strength values, observed skin reactions in animal models).
Adjudication method for the test set:
- Not applicable/Not stated. Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpretation of medical images or data is involved to establish a consensus ground truth. For the physical and biocompatibility testing of gloves, the results are objectively measured against predefined criteria in the standards.
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 physical patient examination glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or AI assistance metrics are not relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product, not an algorithm, so standalone performance in the context of AI is not relevant.
The type of ground truth used:
- Objective Measurement/Standard Compliance: The ground truth for the performance criteria (dimensions, physical properties, freedom from pinholes, powder residual) is established by the specific, objective measurement criteria and threshold values defined within the ASTM standard D 5250-00e4 and 21 CFR 800.20.
- Biological Response in Models: For biocompatibility, the ground truth is based on the observed biological responses in the animal models (rabbits for skin irritation, guinea pigs for dermal sensitization) according to the protocols outlined in ISO10993-10. "Passing" the test means the observed reaction falls below predefined thresholds for irritation or sensitization.
The sample size for the training set:
- Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.

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."

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 SinoCare Plastic Products Co., Ltd
Submitter's address :	NO. 208 YiXi Road, Linzi District, Zibo, Shandong,P.R. China, 255411
Phone number :	(86) 533-7488136
Fax number :	(86) 533-7524666
Name of contact person:	Chen Yan
Date the summary was prepared:	20. May 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, Colored (White, Yellow)
Proprietary/Trade name:	Powder Free Vinyl Patient Examination Gloves
	Other clients private labeling
Common Name:	Patient examination glove
Classification Name:	Patient examination glove
Device Classification:	1
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 frec vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-0064.

Predicate device : Powder-Free Vinyl Patient Examination Gloves,. SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD.,K015156

{(a}(4)] A description of the device

Device Description : powder free vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-0084.

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K051723

Device Description : powder free vinyl patient examination gloves (white, yellow) that meets all of the requirements of ASTM standard D 5250-004

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

Device Intended Use: powder free vinyl patient examination glove colored (white, yellow) 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.

J(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
		Not a Primary Skin Irritation
	Dermal sensitization in theguinea pig	PassesNot a Dermal sensitization

[(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the ((0)(1) A brig. discussion for a determination of substantial equivalence .

Powder free vinyl patient examination gloves (white, yellow) meet requirements per ASTM Powder free Thry Patient 6, 24-01, per 21 CFR 800.20 and ISO10993-10.

[(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket ((v)(2)) it bridge 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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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 is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of three human profiles facing to the right, with three lines above them that appear to represent flowing hair or energy.

JUL 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zibo Sinocare Plastic Products Company c/o Mr. Chu Xiaoan 209 Bei Si Huan Zhong Road Haidian District, Bldg. 1 Beijing, CHINA 100083

Re: K051723

Trade/Device Name: Powder Free Vinyl Patient Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: May 20, 2005 Received: June 27, 2005

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 that I Drederal statutes and regulations administered by other Federal agencies. You must or any 1 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/cdrl/industry/support/index.html.

Sincerely yours,

Sytite y. Michael Ows

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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3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire 510(k) submission must support and agree with the Indications for Use statement.

INDICATIONS FOR USE

Zibo SinoCare Plastic Products Co., Ltd Applicant:____________________________________________________________________________________________________________________________________________________________________

K051723 510(k) Number (if known):___

Device Name: Powder Free Vinyl Patient Examination Gloves, Colored (White, Yellow) 1

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)

Shula H. Munder, M.D. 2/14/05

OW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number: _A 311

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.