Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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

Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

AI/ML Overview

The provided text is a 510(k) summary for Powdered Vinyl Patient Examination Gloves. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence.

Based on the content provided, the device in question is a medical glove, not an AI/ML-driven medical device. Therefore, the questions related to AI/ML device performance (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, and effect sizes of human reader improvement with AI assistance) are not applicable to this document. The provided text does not contain information about an AI/ML device or its performance study.

However, I can extract the acceptance criteria and reported device performance from the provided text for the medical glove.

Acceptance Criteria and Reported Device Performance (for Medical Glove):

Characteristics	Acceptance Criteria (Standard)	Reported Device Performance
Dimension	ASTM standard D 5250-06 e1	Meets
Physical Properties	ASTM standard D 5250-06 e1	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Amount	ASTM standard D 5250-06 e1 and D6124-06	Meets (< 10mg/dm²)
Biocompatibility:
Primary Skin Irritation	AAMI / ANSI / ISO 10993-10 (in rabbits)	Passes (Not a Primary Skin Irritation)
Dermal Sensitization	AAMI / ANSI / ISO 10993-10 (in guinea pig)	Passes (Not a Dermal sensitization)

Study Details (based on provided text for Medical Glove):

Sample sizes used for the test set and the data provenance: Not explicitly stated as a "test set" in the context of AI/ML, but the device was tested against the specified ASTM and CFR standards. No specific sample sizes for these tests are detailed in the summary. Data provenance is not specified beyond the device being manufactured by PPP Medical and Safety Products Company Limited in China. The study is implicitly a nonclinical study, as stated: "A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for medical glove testing typically relies on standardized laboratory procedures and measurements, not expert consensus in the way it's used for AI/ML image interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device and testing.
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 algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the glove, the "ground truth" is adherence to established industry standards and regulations for physical properties, chemical composition (powder amount), freedom from defects (pinholes), and biocompatibility. This is determined through laboratory testing and measurements based on the specified ASTM and CFR standards, rather than clinical outcomes, pathology, or expert consensus on interpretations.
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) submission for a non-AI/ML medical device (patient examination gloves). The "acceptance criteria" relate to meeting established engineering and biocompatibility standards, and the "study" proving this involves nonclinical laboratory testing as per those standards. The concept of "ground truth" here refers to the measured physical and biological properties of the glove conforming to the standard specifications.

Summary

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Section C 510(k) Summary (21 CFR 807.92)

JUL 2 1 2011

510(k) 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: K) 10970 " (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 :	PPP Medical and Safety Products Company Limited
Submitter's address :	Xinlian,Houqiao Town, Wuxi,Jiangsu,214106,China
Phone number :	0086-510-88725378
Fax number :	0086-510-88725378
Name of contact person:	Mr. Zou Xiaojun
Date the summary was prepared:	Feb.9, 2011

[(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:	Powdered Vinyl Patient Examination Gloves,Clear (non-colored)
Proprietary/Trade name:	Powdered Vinyl Patient Examination Gloves,Clear (non-colored)Other clients private labeling
Common Name:	Exam gloves
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* Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

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K110970

. . .

. .

Powdered Vinyl Patient Examination Gloves. Predicate device: Clear(Non-colored) , ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. K091662.

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

Device Description: Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

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

Device Intended Use: Powdered 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 Powdered Vinyl Patient Examination Gloves, Clear (non-colored), 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 el.	Meets
Physical Properties	ASTM standard D 5250-06 el.	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Amount	ASTM standard D 5250-06 eland D6124-06	Meets<10mg/dm²
Biocompatability	Primary Skin Irritation in rabbitsAAMI / ANSI / ISO 10993-10	PassesNot a Primary Skin Irritation
	Dermal sensitization in the guinea pigAAMI / ANSI / ISO 10993-10	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 .

Powdered Vinyl Patient Examination Gloves, Clear (non-colored), meet requirements per ASTM D5250-06 e1. per ASTM D6124-06, per 21 CFR 800.20 and FDA recognition number 2-152: AAMI / ANSI / ISO 10993-10:2002/Amd. 1:2006.

((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 Powdered Vinyl Patient Examination Gloves, Clear (non-colored) meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AOL., meet labeling claims .

It can be concluded that the Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is as safe, as effective, and performs as well as the predicate device, Powdered Vinyl Patient Examination Gloves. Clear(Non-colored) .ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. K091662.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion on the left and a stylized symbol on the right. The symbol features three abstract human profiles facing to the right, stacked on top of each other. The text is arranged in a semi-circular fashion.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

PPP Medical and Safety Products Company Limited C/O Mr. Chu Xiaoan Official Correspondent Beijing Easy-Link Company, Limited Room 1606 Building 1 Jian Xian Yuan NO.209 Bei Si Huan Zhong RD. Hai Di, Beijing China 100083

JUL 2 1 2011

Re: K110970

Trade/Device Name: Powdered 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 1, 2011 Received: July 12, 2011

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. 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 - 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); 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 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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Anthony D. Mather

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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Section B Indications for Use

INDICATIONS FOR USE

PPP Medical and Safety Products Company Limited Applicant:

510(k) Number (if known): * K | | 09 70

Powdered Vinyl Patient Examination Gloves, Clear (non-colored) Device Name:

Indications For Use:

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)

Bunningham (for ecw)

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

510(k) Number: K110970

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.