A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250. Powdered Nitrile Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00a1.

AI/ML Overview

The provided text describes the 510(k) summary for Shijiazhuang Great Vision Plastics Products Co., Ltd. Powdered (Blue) Nitrile Patient Examination Gloves. This product is a Class I medical device and, as such, the acceptance criteria and study information provided mainly pertain to meeting established industry standards for physical properties and biocompatibility, rather than advanced AI/software performance metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Physical and Dimensions Testing (ASTM-D-6319-00a1)	All testing meets requirements for Physical and Dimensions Testing, Inspection Level S-2, AQL 4.0.
Pinhole Detection (FDA 1000 ml. Water Fill Test)	Meets requirements with samplings of AQL 2.5, Inspection Level G-1.
Primary Skin Irritation	No primary skin irritant reactions.
Skin Sensitization (Allergic Contact Dermatitis)	No sensitization reactions.
Residual Powder (ASTM D6124-01 for Starch)	Meets "powder-free" claims (contains no more than 120 mg powder per glove).

Note: The document explicitly states "There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels."

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

The document mentions "samplings" for the FDA 1000 ml. Water Fill Test (AQL 2.5, Inspection Level G-1) and "inspection" for Physical and Dimensions Testing (Inspection Level S-2, AQL 4.0). For Residual Powder testing, it refers to "finished inspection."

Specific sample sizes in units (e.g., number of gloves) are not explicitly provided. The AQL (Acceptable Quality Limit) levels refer to a statistically determined sampling plan, not a fixed number.
Data Provenance: The tests were performed on the manufacturer's gloves, Shijiazhuang Great Vision Plastics Products Co., Ltd., based in Hebei Province, P.R. China. The testing was conducted as part of the manufacturing and submission process, implying it is prospective with respect to the regulatory submission.

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

Not applicable for this type of device. The "ground truth" for glove performance is established by meeting objective, standardized physical and chemical test specifications (e.g., ASTM standards, FDA water fill test). There is no "expert consensus" on an image or clinical finding for this device.
Biocompatibility tests (Primary Skin Irritation and Skin Sensitization) are typically evaluated by qualified toxicologists or dermatologists, but the number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements and pass/fail criteria based on quantitative standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, this is not applicable. This device is a patient examination glove, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

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

Not applicable. This device is a physical product (glove), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device consists of:

Industry Standards: ASTM Standard D6319-00a1 (for physical and dimensional properties).
Regulatory Test Methods: FDA 1000 ml. Water Fill Test (for pinhole detection).
Biocompatibility Standards: Implicitly, standards for evaluating skin irritation and sensitization.
Specific Test Methods for Material Properties: ASTM D6124-01 (for residual starch powder).

8. The Sample Size for the Training Set

Not applicable. This product is a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Summary

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR $807.92.

The assigned 510(k) number is: _ K 02 ! S06

1. Submitter's Identification:

Mr. Chen-Sheng Wei Shijiazhuang Great Vision Plastics Products Co., Ltd. Cangshi S. Road, East District Jinzhou City, Hebei Province P.R. China

Date Summary Prepared: May 03, 2002

Name of the Device: 2.

Shijiazhuang Great Vision Plastics Products Co., Ltd. Powdered (Blue) Nitrile Patient Examination Gloves

3. Predicate Device Information:

Shanghai Poseidon Plastic Products Co., Ltd. Nitrile Examination Gloves, Pre-Powdered, Color Blue (K001837)

4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250. Powdered Nitrile Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00a1.

5. Intended Use:

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6. Comparison to Predicate Devices:

Shijiazhuang Great Vision Plastics Products Co., Ltd. Powdered (Blue) Nitrile Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Shanghai Poseidon Plastic Products Co., Ltd. Nitrile Examination Gloves, Pre-Powdered, Color Blue.

7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:

The standards used for Shijiazhuang Great Vision Plastics Products Co., Ltd. glove production are based on ASTM-D-6319-00a1. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level G-1, meeting these requirements. Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.

There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.

A Residual Powder Test that based on ASTM D6124-01 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free' claims (contain no more than 120 mg powder per glove).

8. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic Claim.

9. Conclusions:

Shijiazhuang Great Vision Plastics Co., Ltd. Powdered (Blue) Nitrile Patient Examination gloves conform fully to ASTM-D-6319-00a1 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.

6 2002 JUN

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shijiazhuang Great Vision Plastic Products Company Limited C/O Mr. James Chu Gloveco Incorporated 12390 East End Avenue Chino, California 91710

Re: K021506

Trade/Device Name: Powdered (Blue) Nitrile Patient Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: May 3, 2002 Received: May 9, 2002

Dear Mr. Chu:

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.

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.

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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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours.

Susan Runored

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment A

Page 1 of 1

510(k) NUMBER (IF KNOWN): K 02 | 506 Shijiazhuang Great Vision Plastics Products Co., Ltd. DEVICE NAME: INDICATIONS FOR USE: Powdered (Blue) Nitrile Patient Examination Gloves

A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrent of CDRH, Office of Device Evaluation (ODE)
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Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter-Use (Optional Format 1-2-96)
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(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices

510(k) Number	K021506
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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.