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 5250-00-4

AI/ML Overview

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

Device: Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)

Summary of Device Performance Study:

The provided text describes a premarket notification for a medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies for Class I devices like examination gloves. The "study" in this context refers to the nonclinical tests conducted to prove the device meets established standards and is comparable to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristics	Acceptance Criteria (Standard)	Reported Device Performance
Dimension	ASTM standard D 5250-00c4	Meets
Physical Properties	ASTM standard D 5250-00c4	Meets
Freedom from Pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 5250-00c4 & D6124-01	<2mg/glove
Biocompatibility (Primary Skin Irritation)	Primary Skin Irritation in rabbits	Passes (Not a Primary Skin Irritation)
Biocompatibility (Dermal Sensitization)	Dermal sensitization in guinea pig	Passes (Not a Dermal sensitization)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the exact sample sizes used for each of the nonclinical tests (Dimension, Physical Properties, Freedom from Pinholes, Powder Residual, Biocompatibility). It only states that the device "meets" the standards.
Data Provenance: The tests are nonclinical, laboratory-based evaluations against established material and performance standards. The country of origin of the data is not explicitly stated, but it would have been generated in a laboratory setting. The data is prospective in the sense that the manufacturer conducted these tests specifically for this device to demonstrate compliance prior to submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This is not applicable in the context of this submission. For nonclinical tests like those for examination gloves, the "ground truth" is defined by the objective, measurable parameters outlined in the ASTM and CFR standards. Expert consensus or review by human experts with specific qualifications (like radiologists) is typically not involved in establishing the ground truth for these types of physical and chemical performance tests. Laboratory technicians and chemists would perform these tests against the predefined standards.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations, particularly in medical image analysis or clinical assessments. For objective nonclinical tests, the results either meet the specified numerical or qualitative criteria of the standard, or they do not. There's no "adjudication" in the traditional sense; rather, it's a direct comparison of measured results against published thresholds.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation (e.g., radiology AI). The device in question is a physical barrier (examination glove), and its performance is assessed through nonclinical, laboratory-based tests against material and functional standards, not by human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, this is not applicable. A standalone algorithm performance study is relevant for AI/ML-based diagnostic devices. The device is a physical product, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for these nonclinical tests is based on established industry and regulatory standards and specifications. Specifically:
- ASTM Standard D 5250-00c4: For dimensions, physical properties, and powder residual. These standards define the acceptable ranges and methodologies.
- 21 CFR 800.20: For freedom from pinholes (waterleak test AQL). This is a regulatory standard defining acceptable defect rates.
- ASTM D6124-01: For powder residual, providing a specific methodology and threshold.
- ISO10993-10: For biocompatibility, which outlines methods for testing irritation and sensitization. The "ground truth" for biocompatibility is derived from the biological responses (or lack thereof) observed in animal models (rabbits for irritation, guinea pigs for sensitization), interpreted according to the standard.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its performance is based on the inherent physical and chemical properties of the manufactured product, which are tested against defined standards.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As the device is not an AI/ML algorithm, there is no training set or corresponding ground truth to establish in that context.

Summary

{0}------------------------------------------------

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 0 70076 " (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 :	JIANGSU CUREGUARD GLOVE CO., LTD.
Submitter's address :	NO. 205 JIANLING ROAD, THE ECONOMICDEVELOPMENT ZONE OF SUQIAN CITY, JIANGSU223800 CHINA
Phone number :	(86) 0527-4568102
Fax number :	(86) 0527-4568100
Name of contact person:	Mr. Zhang Bohoo
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:	Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)
Proprietary/Trade name:	Powder Free 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* powder free vinyl patient examination gloves , Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-0004.

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

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

{1}------------------------------------------------

Device Description : powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

{{a)(5)} The summary describes the intended use of the device

Device Intended Use: powder free 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 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 5250-00c4	Meets
Physical Properties	ASTM standard D 5250-00c4	Meets
Freedom from pinholes	21 CFR 800.20	Meets
Powder Residual	ASTM standard D 5250-00c4	Meets
	and D6124-01	<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 nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .

Powder free vinyl patient examination gloves , Clear(non-colored) meet requirements per ASTM D5250-00-4, 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 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 .

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jiangsu Cureguard Glove Company Limited C/O Chu Xiaoan Beijing Easy-Link Company Room 1606, Building 1, Jianx Yuan No. 209 Bei Si Huan Zhong Road Haidian District. Beijing 100083 P.R. CHINA

Re: K070076

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: January 2, 2007 Received: January 8, 2007

-EB 2 2 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 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.

Image /page/2/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is written in a sans-serif font.

{3}------------------------------------------------

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 (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.

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,

Clues

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

{4}------------------------------------------------

INDICATIONS FOR USE

Applicant:_JIANGSU CUREGUARD GLOVE CO., LTD.

510(k) Number (if known): * 1

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)

Stole P. Murphy

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.