Powdered 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

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed,

AI/ML Overview

This is a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)". This type of device does not involve AI/ML technology, imaging, or diagnostics, and therefore the requested information regarding AI/ML study design, reader studies, and ground truth establishment is not applicable. The device is a Class I medical device, which typically relies on established performance standards and non-clinical testing for substantial equivalence.

Here's the relevant information from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristics	Acceptance Criteria (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 Amount	ASTM Standard D 5250-00e4	Meets
Biocompatibility:
Contact to skin (e.g. skin irritation)	Primary Skin Irritation in rabbits	Passes (Not a Primary Skin Irritation)
Hypersensitivity	Dermal sensitization in the guinea pig	Passes (Not a Dermal sensitization)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to meeting established ASTM standards and CFR regulations for glove performance. These standards prescribe specific test methods and sample sizes. For example:

Freedom from pinholes (21 CFR 800.20): This regulation specifies an Acceptable Quality Level (AQL) which implicates a statistically derived sample size for testing.
ASTM D5250-00e4 (Standard Specification for Poly(Vinyl Chloride) Gloves for Medical Application): This standard outlines specific test methods and the number of specimens required for various tests like dimensions, physical properties (tensile strength, elongation), and powder amount. The document does not provide the specific number of gloves tested for this submission, but it implies compliance with the sampling requirements of these standards.
Biocompatibility tests (ISO10993-10): These tests also have defined sample sizes for animal models (rabbits for skin irritation, guinea pigs for sensitization).

The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective, but it's generated by the manufacturer, SHIJIAZHUANG PROSPEROUS PLASTIC CO.,LTD, based in China, for submission to the FDA in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical product (gloves), and performance is assessed against standardized physical and chemical tests rather than expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML or diagnostic device that requires expert adjudication for ground truth.

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

Not applicable. MRMC studies are for diagnostic devices, particularly those involving human readers and AI assistance. This is a medical glove.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is based on pre-defined, objective, and standardized measurements as specified by the referenced ASTM standards (e.g., D 5250-00e4, D6124-01) and regulatory requirements (21 CFR 800.20, ISO10993-10). For example:

Physical properties (tensile strength, elongation) are measured objectively.
Freedom from pinholes is determined by a water leak test.
Biocompatibility is determined by standardized animal tests with observable outcomes (absence of irritation or sensitization).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set or ground truth establishment for it.

Summary

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2 2008

"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 :	SHIJIAZHUANG PROSPEROUS PLASTIC CO.,LTD
Submitter's address :	TAITOU HUAIAN ROAD, SHIJIAZHUANG CITY,HEBEI,050000,P.R.CHINA
Phone number :	(86) 311-83021139
Fax number :	(86) 311-83021139
Name of contact person:	Ms. Xue Feng
Date the summary was prepared:	Oct. 15,2007

[(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 GlovesClear (Non-colored)
Proprietary/Trade name:	Powdered Vinyl Patient Examination GlovesOther clients private labeling
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* powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-0004.

Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032907.

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

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Device Description : powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed,

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

Device Intended Use: powdered vinyl patient examination glove, 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 5250-00e4.	Meets
Physical Properties	ASTM standard D 5250-00e4.	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Amount	ASTM standard D 5250-00e4	Meets
Biocompatability		$<10mg/dm^2$
	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 premarket notification submission for a determination of substantial equivalence .

Powdered vinyl patient examination gloves , Clear(non-colored) meet requirements per ASTM D5250-0044, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10.

[(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket 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, Clear(non-colored) meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL, meet labeling claims .

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2008

Mr. Chu Xiaoan Official Correspondent Shijiazhuang Prosperous Plastic Company, Limited Room 1606 Building 1, Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District, Beijing 10083 P. R. CHINA

Re: K073192

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: April 11, 2008 Received: April 14, 2008

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 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); 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.

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/cdrh/industry/support/index.html.

Sincerely yours,

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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INDICATIONS FOR USE

Applicant:_SHIJIAZHUANG PROSPEROUS PLASTIC CO.,LTD

510(k) Number (if known): *

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

Indications For Use:

Powdered 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)

Shila R Murphy, RPh
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K073142

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.