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, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)":

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Standard)	Reported Device Performance
Dimension	ASTM standard D 5250-06	Meets
Physical Properties	ASTM standard D 5250-06	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 5250-06 and D6124-06	Meets (<2mg/glove)
Biocompatibility (Primary Skin Irritation)	Primary Skin Irritation in rabbits	Passes (Not a Primary Skin Irritation)
Biocompatibility (Dermal Sensitization)	Dermal sensitization in the guinea pig	Passes (Not a Dermal sensitization)

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

The document does not explicitly state the sample size used for the test set for any of the performance characteristics. It refers to compliance with standards (ASTM D 5250-06, 21 CFR 800.20, D6124-06, and ISO10993-10), which would detail the required sample sizes for testing.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that the manufacturer is "Hebei Hongtai Plastic Products Co.,Ltd." in China, it is highly probable the testing was conducted in China. The testing appears to be prospective, as it's to demonstrate compliance of the manufactured device.

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

This information is not provided in the document. The standards mentioned define the test methodologies, but not the specific experts involved in evaluating the results or their qualifications. For device performance like glove characteristics, "ground truth" is typically established by the results of standardized physical and chemical tests, rather than expert consensus on subjective evaluations. For biocompatibility, the interpretation of the animal study results would be done by qualified toxicologists or pathologists, but the text doesn't specify who performed this interpretation or how many.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the tests (mechanical, chemical, and animal biocompatibility), an adjudication method in the sense of multiple human readers or subjective evaluations is generally not applicable. The results are typically objectively measured against defined pass/fail criteria within the standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or subjective interpretation tasks involving human readers, which is not applicable to patient examination gloves.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

N/A. This device is a physical product (gloves), not an algorithm or AI system. Therefore, the concept of a "standalone" algorithm performance does not apply.

7. Type of Ground Truth Used:

The ground truth used is primarily compliance with established industry standards and regulations. Specifically:

Mechanical and Physical Properties: Defined specifications within ASTM standard D 5250-06 (e.g., tensile strength, elongation, dimensions).
Freedom from Pinhole: Defined acceptance quality limits (AQL) in 21 CFR 800.20 (Waterleak test).
Powder Residual: Defined limits and test methods in ASTM standard D 5250-06 and D6124-06.
Biocompatibility: Results of animal studies (Primary Skin Irritation in rabbits, Dermal sensitization in guinea pig) interpreted against established toxicological criteria, likely guided by ISO 10993-10. The "ground truth" here is the biological response observed and its classification as "Passes" or "Fails" based on established toxicological guidelines.

8. Sample Size for the Training Set:

N/A. This device is a physical product and not an AI/ML model. Therefore, there is no "training set" in the context of machine learning. The "training" for such devices involves setting up manufacturing processes to consistently meet specifications.

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

N/A. As mentioned above, there is no training set for this type of device. The ground truth for manufacturing and quality control would be the same as the acceptance criteria for the final product: adherence to ASTM standards, CFR regulations, and ISO guidelines.

Summary

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Summary

DEC 2 3 2010

K102819

"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: _ _ _ _ _ _ _ _ . " (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 :	Hebei Hongtai Plastic Products Co.,Ltd.
Submitter's address :	No 15 ,Luban Road, Julu county ,Xingtai, HebeProvince, 055250 , CHINA
Phone number :	(86) 319-4362388
Fax number :	(86) 319-4362388
Name of contact person:	Mrs. Renxia Han
Date the summary was prepared:	Sep. 20th, 2010

[(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(Yellow)
Proprietary/Trade name:	Powder Free Vinyl Patient Examination Gloves
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, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

Predicate device : Powder-Free Vinyl Patient Examination Gloves,. SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD.,K051156 .

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

Device Description : powder free vinyl patient examination gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

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K102819

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

Device-Intended Use: powder free-vinyl patient examination glove, Colored (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.

[(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 5250-06	Meets
Physical Properties	ASTM standard D 5250-06	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 5250-06	Meets
	and D6124-06	<2mg/glove
Biocompatability	Primary Skin Irritation in rabbits	Passes
		Not a Primary Skin Irritation
	Dermal sensitization in the guinea pig	Passes
		Not a Dermal sensitization

[(b)(1)] A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.

Powder free vinyl patient examination gloves , Colored (Yellow) meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10. , it is safe and effective, and it's performance meets the requirements of its pre-defined acceptance criteria and intended uses.

[(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 . It is as safe,as effective, and performed as well the legally marketed device identified in (a)(3).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mrs. Renxia Han Quality Assurance Manager Hebei Hongtai Plastic Products Company, Limited No 15, Luban Road, Julu County Xingtai, Hebe Province China 055250

DEC 2 3 2010

Re: K102819

Trade/Device Name: Powder Free Vinyl Patient Examination Gloves Colored (Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: September 20, 2010 Received: November 17, 2010

Dear Mrs. Han:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Mrs. Han

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

James J. Rosolack
for

Anthony D. Watson, B.S., M.S., M.B.A. 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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DEC 2 3 2010

(102819

_INDICATIONS FOR USE

Applicant: Hebei Hongtai Plastic Products Co.,Ltd.

510(k) Number (if known): *

Device Name:_Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)

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 eon Sign-Off)
on of Anesthesiology, General Hospital
Ton of Anesthesiology, General Devices rol, Dental Devices 510(k) Number

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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.