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

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study for Powdered Vinyl Patient Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristics	Standard	Acceptance Criteria	Device Performance
Dimension	ASTM standard D 5250-00e4	Meets ASTM standard D 5250-00e4	Meets
Physical Properties	ASTM standard D 5250-00e4	Meets ASTM standard D 5250-00e4	Meets
Freedom from pinholes	21 CFR 800.20	Meets 21 CFR 800.20 (Waterleak test on pinhole AQL)	Meets
Powder Amount	ASTM standard D 5250-00e4	Meets ASTM standard D 5250-00e4 (<10mg/dm2)	Meets
Biocompatibility (Primary Skin Irritation)	ISO10993-10 (Primary Skin Irritation in rabbits)	Passes / Not a Primary Skin Irritation	Passes / Not a Primary Skin Irritation
Biocompatibility (Dermal Sensitization)	ISO10993-10 (Dermal sensitization in the guinea pig)	Passes / Not a Dermal Sensitization	Passes / Not a Dermal Sensitization

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: The document does not specify a distinct "test set" sample size for each characteristic. It simply states that the device "Meets" the specified standards. For freedom from pinholes, the "waterleak test on pinhole AQL" implies a statistical sampling method as defined by the AQL (Acceptable Quality Level) in 21 CFR 800.20, but the specific sample size, number of defects allowed, or number of units tested are not provided. Similarly for biocompatibility, it's not explicitly stated how many rabbits or guinea pigs were used.
Data Provenance: The studies appear to be prospective as they were conducted by the manufacturer (Wuxi Shenzhou Plastic Products Co., LTD) to demonstrate that their device meets the requirements.
Country of Origin of the Data: The manufacturing company is located in Wuxi City, Jiangsu Province, P.R.China. It is reasonable to infer that the testing was conducted in China, though it's not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For physical and chemical tests like dimension, physical properties, powder amount, and pinholes, the "ground truth" is typically established by direct measurement against the specified standard (e.g., using calipers, tensile strength testers, or standardized water leak tests). For biocompatibility, the ground truth is established by trained toxicologists or researchers interpreting the biological responses in animal models, but the number and qualifications of these experts are not explicitly mentioned.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used when there are subjective interpretations involved, often in image-based diagnostics where multiple experts might disagree on a finding. The tests for these gloves (dimension, physical properties, pinholes, powder, biocompatibility) are primarily objective measurements against established standards, not requiring human adjudication in the same way.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not the case for patient examination gloves.

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

No, a standalone algorithm-only performance study was not done. This concept is also not applicable to the device in question (patient examination gloves). The testing performed is to assess the physical, chemical, and biological properties of the glove itself.

7. The type of ground truth used:

Dimension, Physical Properties, Powder Amount: The ground truth is based on direct measurement and comparison to the specifications outlined in ASTM standard D 5250-00e4.
Freedom from pinholes: The ground truth is established by a standardized water leak test as per 21 CFR 800.20.
Biocompatibility: The ground truth is established through animal testing (Primary Skin Irritation in rabbits, Dermal Sensitization in guinea pigs) according to ISO10993-10, with results interpreted as "Passes" or "Not a Primary/Dermal Sensitization."

8. The sample size for the training set:

Not applicable/Not provided. This device is a physical product (gloves), not an AI algorithm, so there is no concept of a "training set" in the context of machine learning. The manufacturer likely had internal quality control and development data, but this is not a training set for an AI model.

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

Not applicable/Not provided for the same reasons as point 8.

Summary

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K070145

Summary

FEB 9 8 2007

"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 :	WUXI SHENZHOU PLASTIC PRODUCTS CO., LTD
Submitter's address :	Caomutang , Houqiao Town, Wuxi City,Jiangsu Province, P.R.China, 214106
Phone number :	86 510 88725811
Fax number :	86 510 88727280
Name of contact person:	Mr. Ping AN
Date the summary was prepared:	Jan.02,2007

[(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 Gloves,Clear (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 5250-00e4

Predicate device : FUGUAN (Brand) Powdered Vinyl Patient Examination Gloves, Shijazhuang 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	Primary Skin Irritation in rabbits	<10mg/dm2
		Passes
		Not a Primary Skin Irritation
	Dermal sensitization in the guinea pig	Passes
		Not 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 yinyl patient examination gloves , Clear(non-colored) meet requirements per ASTM D5250-000d, 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 with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

WUXI Shenzhou Plastic Products Company, Limited C/O Mr. Chu Xiaoan Beijing Fasy-Link Company 209 Bei Si Huan Zhong Road, Room 1606, Building 1, Jianxiang Yuan Haidian District. Beijing 100083, P. R. CHINA

FEB 2 8 2007

Re: K070145

Trade/Device Name: Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LYZ Dated: January 2, 2007 Received: January 16, 2007

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 cquivalent (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 sct forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Scctions 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ري جي جو Shor Kuns

T . 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: WUXI SHENZHOU PLASTIC PRODUCTS 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)

Shiela H. Humphrey, MD

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

510(k) Number. K120451

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.