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 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, Powder-Free (yellow) Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-92.

AI/ML Overview

This is a 510(k) summary for a medical device that is a Shijiazhuang Great Eagle Plastics Products Co., Ltd. Synthetic Powder-Free (Yellow) Vinyl Patient Examination Glove. This submission is for a Class I medical device, which generally means it poses a lower risk to patients and users and often relies on established performance standards rather than extensive clinical studies for approval.

The document describes non-clinical tests performed to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria in the way one might describe for an AI/ML digital health product or more complex diagnostic device. For this type of glove device, acceptance criteria are tied to manufacturing standards and physical properties.

Here's the breakdown of the information requested, tailored to what's available for this specific medical device submission:

Information Requested	Details for Shijiazhuang Great Eagle Plastics Products Co., Ltd. Synthetic Powder-Free (Yellow) Vinyl Patient Examination Gloves
1. Acceptance Criteria and Reported Device Performance
Acceptance Criteria	Reported Device Performance
ASTM-D-5250-92 Standard Compliance (Physical and Dimensions Testing)	All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0.
FDA 1000 ml. Water Fill Test (Pinhole integrity)	Samplings of AQL 2.5, Inspection Level S-4, met requirements.
Biocompatibility (Primary Skin Irritation and Skin Sensitization)	Results showing no primary skin irritant or sensitization reactions.
Powder-Free Claim (USP Iodine Test for Starch)	Revealed passing results, adhering to USP Iodine test methodology.
2. Sample size for test set and data provenance	The document does not specify a distinct "test set" sample size in the context of an AI/ML study. For the physical and performance tests, "samplings" were taken from production, with "Inspection Level S-2, AQL 4.0" for physical and dimensions, and "AQL 2.5, Inspection Level S-4" for the water fill test. This refers to statistical sampling plans used in quality control. The data provenance is implied to be from the manufacturer's internal testing as part of their production and quality assurance processes (China). The study is retrospective in the sense that these are manufacturing quality control tests conducted on finished products.
3. Number of experts used to establish ground truth & qualifications	For this device (patient examination gloves), "ground truth" is established through standardized laboratory tests and adherence to established material and performance specifications (ASTM standards, FDA water fill test, USP tests). There isn't a team of human "experts" establishing a diagnostic ground truth in the way described for AI/ML. The "experts" are the laboratory technicians and quality control personnel performing the defined tests and interpreting the results against the established standards. No specific number or qualifications are provided beyond the implicit expertise in conducting these standard tests.
4. Adjudication method for the test set	Not applicable in the context of diagnostic performance. Quality control for manufacturing relies on standardized test methods with pass/fail criteria. There isn't an "adjudication method" involving multiple human readers as in clinical image interpretation.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study	Not applicable. This is for a physical medical device (examination gloves), not an AI/ML system or diagnostic tool where human readers' performance would be evaluated.
6. Standalone (algorithm only) performance study	Not applicable. This is for a physical medical device (examination gloves). There is no algorithm.
7. Type of ground truth used	The ground truth is based on established industry standards and regulatory testing protocols: - ASTM Standard D5250-92 (for physical and dimensional properties) - FDA 1000 ml. Water Fill Test (for pinhole integrity) - Biocompatibility testing (Primary Skin Irritation and Skin Sensitization tests) - USP Iodine Test (for powder-free claim verification).
8. Sample size for the training set	Not applicable. This is for a physical medical device, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established	Not applicable. This is for a physical medical device.

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: K99286

1. Submitter's Identification:

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: Aug 5, 1999

Name of the Device: 2.

Shijiazhuang Great Eagle Plastics Products Co., Ltd. Synthetic Powder-Free (Yellow) Vinyl Patient Examination Gloves

3. Device Description:

4. Intended Use:

5. Comparison to Predicate Devices:

Shijiazhuang Great Eagle Plastics Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves and the Cheer & Merit Powder-Free Vinyl Patient Examination Gloves.

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6. 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. glove production are based on ASTM-D-5250-92. 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 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.

A USP Iodine Test for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free' claims. We adhere to all USP Iodine test methodogy and testing conducted revealed passing results.

7. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic Claim.

8. Conclusions:

Shijiazhuang Great Eagle Plastics Co., Ltd. Synthetic Vinyl Patient Examination gloves (Powder-Free) conform fully to ASTM-D-5250-92 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility 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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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and recognizable, conveying the department's authority and commitment to public service.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 6 1999

Shijiazhuang Great Eagle Plastics Products Co., Ltd. C/O Ms. Susan D. Goldstein-Falk Official Correspondent Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710

Re : K992861 Synthetic Powder-Free (Yellow) Vinyl Patient Trade Name: Examination Gloves Regulatory Class: I Product Code: LYZ Dated: August 23, 1999 Received: August 23, 1999

Dear Ms. Susan D. 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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your

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Page 2 - Ms. Susan D. Goldstein-Falk

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

K992861

DEVICE NAME: INDICATIONS FOR USE:

510(k) Number (if known):

Shijiazhuang Great Eagle Plastics Products Co., Ltd. Synthetic Powder-Free (Yellow) Vinyl Patient Examination Gloves-Powder-Free

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)

(Division Sign-Off)
	Division of Dental, Infection Control,
	and General Hospital Devices
510(k) Number	K992861
Prescription Use		Over-The-Counter Use	X
(Per 21 CFR 801.109)	OR	(Optional Format 1-2-96)

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.