Powdered Vinyl Patient Examination Gloves, Light Yellow Color 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, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.

AI/ML Overview

The provided text describes a 510(k) summary for "Powdered Vinyl Patient Examination Gloves, Light Yellow Color." This is a medical device that falls under the category of general hospital devices, specifically patient examination gloves.

The text does not describe an AI/ML powered device, nor does it involve any studies related to human readers, AI assistance, or complex diagnostic tasks. The "acceptance criteria" and "study" described in the document are for basic physical, chemical, and biological properties of the gloves, not for an AI algorithm.

Therefore, I cannot extract the information required for the requested table and parameters related to an AI/ML device. The document pertains to a much simpler Class I medical device.

Here's a breakdown of why this document doesn't fit the request and what information can be extracted:

No AI/ML Component: The device is a physical product (gloves), not a software or AI-driven system.
No "Ground Truth" for AI: Concepts like expert consensus, pathology, or outcomes data as "ground truth" are irrelevant for examination gloves.
No "Readers" or "Adjudication": There are no human readers or AI algorithms being evaluated in a diagnostic context.
No "Sample Size for Test/Training Set" in AI Sense: The phrase "sample size" in this document refers to the quantity of gloves tested for physical properties (e.g., freedom from pinholes), not data points for an AI model.
No "Effect Size of Human Readers Improve with AI": This is completely unrelated to the device described.

What can be extracted related to "acceptance criteria" from the provided text for this specific device:

The "acceptance criteria" are essentially the relevant ASTM standards and FDA regulations that the gloves must meet. The "device performance" is stated as "Meets" for all these criteria.

Table of Acceptance Criteria and Reported Device Performance (as per the document):

Acceptance Criteria / Characteristic	Reference Standard	Reported 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 el and D6124-06	Meets (<10mg/dm²)
Biocompatibility:
Primary Skin Irritation	AAMI / ANSI / ISO 10993-10	Passes (Not a Primary Skin Irritation)
Dermal sensitization	AAMI / ANSI / ISO 10993-10	Passes (Not a Dermal sensitization)

Regarding the other requested information (which is not applicable to this device type):

Sample sized used for the test set and the data provenance: The document indicates that the product "meets" various ASTM standards and CFR regulations. These standards define the sampling plans for testing. For example, ASTM D5250 specifies various testing methods and sampling requirements (e.g., for physical properties, freedom from holes). However, the specific sample sizes used in this particular submission's tests are not detailed in the summary, only that the product met the standards. The data provenance is implied to be from the manufacturer's internal testing as part of their quality control and submission process, likely conducted in China (based on the manufacturer's location).
Number of experts used to establish the ground truth...: Not applicable. Ground truth for a glove is its physical properties, not expert interpretation.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For gloves, the "ground truth" is defined by the objective measurements and tests prescribed by the relevant ASTM standards and FDA regulations (e.g., tensile strength, elongation, barrier integrity, protein content, powder amount).
The sample size for the training set: Not applicable as there is no "training set" for an AI model.
How the ground truth for the training set was established: Not applicable.

In conclusion, the provided text describes a traditional medical device (patient examination gloves) and its regulatory compliance, not an AI/ML powered device. Therefore, the specific questions related to AI/ML device evaluation criteria cannot be answered from this document.

Summary

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

510(k) Summary

JUL 2 1 2011

"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."

KIIO96 (applicant leave blank) "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 :	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, Light Yellow Color

Proprietary/Trade name:

Powdered Vinyl Patient Examination Gloves, Light Yellow Color Other clients private labeling

Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:

Exam gloves Patient examination glove I 21 CFR 880.6250 General Hospital (80) 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, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.

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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, Light Yellow Color 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, Light Yellow Color 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, Light Yellow Color, 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, Light Yellow Color, 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 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 Powdered Vinyl Patient Examination Gloves, Light Yellow Color 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, Light Yellow Color 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 a logo with two distinct parts. On the left, there is a circular seal with text arranged around the perimeter, reading "DEPARTMENT OF HEALTH & HUMAN". To the right of the seal, there is a stylized graphic consisting of three curved, parallel lines that resemble a symbol or abstract representation of a flag.

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: K110966

Trade/Device Name: Powdered Vinyl Patient Examination Gloves, Light Yellow Color

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 (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/ucm 115809.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. Winter

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:

110966 510(k) Number (if known): *

Powdered Vinyl Patient Examination Gloves, Light Yellow Color 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)

Runningham (for ECW)

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

510(k) Number: K110966

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.