A glove 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 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

Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glove, 80LYZ, powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

AI/ML Overview

This submission describes the clearance of "Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves-Powdered" manufactured by SHIJIAZHUANG GREAT EAGLE PLASTICS PRODUCTS CO., LTD. This is a Class I medical device (21 CFR 880.6250) and is intended for medical purposes to prevent contamination between patients and examiners. The device's performance was evaluated against ASTM Standard D5250-92 and FDA's 1000 ml water fill test.

Here’s a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from ASTM Standard D5250-92 & FDA 1000 ml Water Fill Test)	Reported Device Performance
Physical and Dimensions Testing: All requirements of ASTM D5250-92 (Specific parameters not detailed in the provided text, but generally include dimensions, tensile strength, elongation, etc.)	All testing meets requirements for Physical and Dimensions Testing conductive on gloves, Inspection Level S-4, AQL 4.0.
Pinhole / Water Leakage Test: Requirements of FDA 1000 ml Water Fill Test (Specific AQL level for leakage)	FDA 1000 ml Water Fill Test conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements.
Primary Skin Irritation: No primary skin irritant reactions	No primary skin irritant reactions observed.
Skin Sensitization (Allergic Contact Dermatitis): No sensitization reactions	No sensitization reactions observed.

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

Test Set Sample Size:
- For Physical and Dimensions Testing: AQL 4.0, Inspection Level S-4 (Specific number of gloves not provided, but AQL and inspection level define the sampling plan).
- For FDA 1000 ml Water Fill Test: AQL 2.5, Inspection Level S-4 (Specific number of gloves not provided, but AQL and inspection level define the sampling plan).
- For Primary Skin Irritation and Skin Sensitization: Not specified, but generally follows standard biological evaluation protocols.
Data Provenance: Not explicitly stated, but assumed to be generated by the manufacturer or a contract research organization in China, as the manufacturer is based in Shijiazhuang, Hebei Province, P.R. China. The studies are prospective, conducted specifically for this submission.

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

Not applicable. For this type of device (patient examination gloves), "ground truth" is established through standardized physical, chemical, and biological performance tests rather than expert interpretation of medical images or clinical data. The tests are objective measurements against established criteria.

4. Adjudication Method for the Test Set:

Not applicable. As the "ground truth" is based on objective measurements from standardized tests, there is no need for expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:

No. An MRMC study is not relevant for this device. It is generally used for evaluating diagnostic devices where human readers interpret medical data.

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

Not applicable. This device is a physical product (gloves), not an algorithm or AI system. Its performance is evaluated through physical and biological testing.

7. The Type of Ground Truth Used:

The "ground truth" for the performance evaluation of the gloves is based on:
- Standardized Test Methods: Adherence to ASTM D5250-92 for physical properties and dimensions.
- Regulatory Test Methods: Compliance with the FDA 1000 ml Water Fill Test for barrier integrity (pinhole detection).
- Biocompatibility Testing: Results from Primary Skin Irritation and Skin Sensitization tests.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm; 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 for an AI/ML algorithm.

Summary

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SHIJIAZHUANG GREAT EAGLE PLASTICS PRODUCTS CO., LTD.

685 He Ping Road, New Development Zone, Shijiazhuang, Hebei Province 05003 1 P.R. China

NOV 2 9 1999

EXHIBIT #1

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92.

The assigned 510(k) number is:_K99.2862

Submitter's Identification: 1.

Mr. Fang Yi Liu Shijiazhuang Great Eagle Plastics Products Co., Ltd. 685 He Ping Road New Development Zone Shijiazhuang, Hebei Province 050031 P.R. China

Date Summary Prepared: August 1999

2. Name of the Device:

Shijiazhuang Great Eagle Plastics Products Co., Ltd.

Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves-Powdered

3. Predicate Device Information:

Shijiazhuang Great Eagle Plastics Products Company, Ltd. Powdered Vinyl Patient Examination Gloves, K# 983645

4. Device Description:

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SHIJIAZHUANG GREAT EAGLE PLASTICS PRODUCTS CO., LTD.

685 He Ping Road, New Development Zone, Shijiazhuang, Hebei Province 05003 1 P.R. China

ડ. Intended Use:

A glove 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.

Comparison to Predicate Devices: 6.

Shijiazhuang Great Eagle Plastics Products Co., Ltd. Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastics Products Co., Ltd. Powdered Vinyl Patient Examination Gloves.

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

The standards used for Shijiazhuang Great Eagle Plastics Products Co., Ltd. production are based on ASTM D5250-92. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-4, AQL 4.0.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level S-4, 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.

Shijiazhuang Great Eagle Plastics Products Co., Ltd., operates in compliance with FDA's GMP's.

Discussion of Clinical Tests Performed: 8.

Not Applicable - There is not hypoallergenic claim.

9. Conclusions:

Shijiazhuang Great Eagle Plastics Products Co., Ltd. Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves conform fully to ASTM D5250-92 standards as well as applicable 21 CFR references, and meets pinhole FDA requirements, bio-compatibility requirements and labeling claims as shown by data submitted to FDA. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned within a circular border. Encircling the bird and following the curve of the circle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 1999

Ms. Susan D. Goldstein-Falk Official Correspondent for Shijiazhuang Great Eagle Plastics Products Company, Limited 685 He Ping Road, New Development Zone Shijiazhuanq, Hebei Province 050031 P.R. China

Re : K992862 Powdered Vinyl Patient Examination Gloves Trade Name: (Yellow) Regulatory Class: I Product Code: LYZ November 3, 1999 Dated: November 5, 1999 Received:

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Ms. Goldstein-Falk

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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):	K99 2862
DEVICE NAME:	Shijiazhuang Great Eagle Plastics Products Co., Ltd.
INDICATIONS FOR USE:	Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves-Powdered

A 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _X (Optional Format 1-2-96)

Ab In Clin.

Division of Dental, Infection Control, Cal Hoanits 510(k) Number

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.