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 5250-06.

AI/ML Overview

The provided document is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves," a Class I medical device. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of an AI/ML powered device. The information requested (acceptance criteria, specific study details for AI/ML, sample sizes for training/test sets, expert adjudication methods, MRMC studies, etc.) is typically associated with AI/ML device submissions, which are significantly different in scope and requirements from a Class I glove submission.

Therefore, the requested information, which is primarily relevant to AI/ML powered devices, is not applicable and not available in this submission for the following reasons:

Device Type: The device is a "Powder Free Vinyl Patient Examination Glove," a physical, low-risk medical device. It does not involve any imaging, diagnostic algorithms, or AI/Machine Learning components.
Regulatory Pathway: This is a 510(k) submission for a Class I device, which relies heavily on demonstrating conformance to established standards (like ASTM) and substantial equivalence to a legally marketed predicate device. The detailed performance studies typical for AI/ML devices, especially those requiring complex ground truth establishment and human-in-the-loop assessments, are not required for this type of device.
Nature of "Performance": For gloves, "performance" relates to physical properties, freedom from defects (like pinholes), and biocompatibility, as opposed to diagnostic accuracy or clinical decision support.

However, I can extract the acceptance criteria and the device performance as reported in the summary for the glove, which is the closest equivalent to your request within the provided text.

Here is the information based on the provided K102817 document, adapted to the context of a medical glove:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristics	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	Meets
	and D6124-06	<2mg/glove
Biocompatibility:
Primary Skin Irritation	in rabbits	Passes (Not a Primary Skin Irritation)
Dermal Sensitization	in the guinea pig	Passes (Not a Dermal sensitization)

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a non-clinical testing program where the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" were evaluated against the specific requirements of the listed ASTM standards, 21 CFR 800.20, and ISO10993-10 for biocompatibility. The summary states that the device "meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10." This indicates that tests were conducted according to these standards, and the device's measured properties (dimensions, physical properties, pinhole freedom, powder residual, skin irritation, dermal sensitization) fell within the acceptable limits defined by those standards.

The following questions are not applicable (N/A) to this device submission, as it is for a physical medical glove and not an AI/ML-powered diagnostic or assistive device.

2. Sample size used for the test set and the data provenance: N/A (No test set in the context of AI/ML data; testing based on glove samples and standard methods).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth is defined by physical/chemical measurements against standards, not expert consensus on data).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A (No expert adjudication involved for physical glove testing).
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: N/A (No AI, no readers involved).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A (No algorithm).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the glove, the "ground truth" or reference is defined by established international and national standards (ASTM, FDA regulations for pinholes, ISO for biocompatibility). These standards specify acceptable ranges or outcomes for physical and chemical properties.
8. The sample size for the training set: N/A (No training set for an AI/ML model).
9. How the ground truth for the training set was established: N/A (No training set for an AI/ML model).

Summary

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K102817

Summary

DEC 2 3 2010

"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

[(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, Clear (non-colored)
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, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06.

Predicate device : FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 .

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

Device Description : Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)that meets all of the requirements of ASTM standard D 5250-06.

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K102817

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

(

Device Intended Use: Powder Free Vinyl Patient Examination Gloves, 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 5250-06	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 inrabbits	Passes
		Not a Primary Skin Irritation
	Dermal sensitization in theguinea 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, Clear (non-colored)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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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 2019

Re: K102817

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: 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) (2) CFR 803); 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.

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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Jum-J. Rodriquez

Anthony D. Watson, B.S., M.S., M.B., M.BA. 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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K102817

INDICATIONS FOR USE

Applicant: Hebei Hongtai Plastic Products Co.,Ltd.

DEC 2 3 2010

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)

Elizabeth D. Clavine-Wells

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices n 0! Anesticolous Devices

510(k) Number: K102817

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.