A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare similar personnel to prevent contamination between and 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 Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient as Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.

AI/ML Overview

The provided document describes the 510(k) summary for the Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves. It details the device, its intended use, comparison to predicate devices, and non-clinical tests performed to demonstrate substantial equivalence.

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

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Physical and Dimensions Testing (ASTM D5250-92)	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	Conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements.
Primary Skin Irritation	Results showing no primary skin irritant reactions.
Skin Sensitization (allergic contact dermatitis)	Results showing no sensitization reactions.
USP Iodine Test for Starch (Powder-Free Claim)	Adheres to all USP Iodine Test methodology and testing conducted revealed passing results, insuring the "powder-free" claim.
Biocompatibility requirements	Met (as stated in the conclusion).
Labeling claims (no hypoallergenic claim)	Met (no special labeling claims, no hypoallergenic claim).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes for each test conducted. It mentions "samplings of AQL 2.5, Inspection Level S-4" for the Water Fill Test and "Inspection Level S-2, AQL 4.0" for Physical and Dimensions Testing, which are statistical sampling plans but don't provide a direct sample count. The tests were performed on gloves produced by Shijiazhuang Great Eagle Plastic Products Co., Ltd. in Shijiazhuang, He Bei Province, P.R. China. The data would be prospective, as it's generated during the production and testing of new devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is Not Applicable. The device is a medical glove, and its performance is evaluated against established technical standards (ASTM, FDA water fill, USP iodine test) and biocompatibility tests. These tests have objective criteria and do not rely on expert interpretation to establish "ground truth" in the way a diagnostic imaging device might.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is Not Applicable. As explained above, the tests performed on the gloves are objective and rely on direct measurements and observations against predefined pass/fail criteria, not on subjective expert consensus or adjudication.

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

This section is Not Applicable. The device is a patient examination glove, not an AI-powered diagnostic tool. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant.

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

This section is Not Applicable. The device is a physical medical glove and does not involve any algorithms or AI for standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device, a medical glove, is defined by objective, measurable compliance with established international and regulatory standards and test methods:

ASTM Standard D5250-92: This standard defines physical properties and dimensions for vinyl examination gloves. The "ground truth" is whether the glove's measured properties (e.g., tensile strength, elongation, dimensions) fall within the specified ranges.
FDA 1000 ml. Water Fill Test: This test determines the watertight integrity (pinhole defects) of the gloves. The "ground truth" is a pass/fail outcome based on whether water leaks through the glove under specific conditions.
Primary Skin Irritation and Skin Sensitization Testing: These are biological tests conducted to assess the biocompatibility of the glove material. The "ground truth" is the absence of observed irritation or sensitization reactions in test subjects/models.
USP Iodine Test for Starch: This test objectively determines the presence or absence of starch, which is critical for a "powder-free" claim. The "ground truth" is a passing result indicating minimal or no starch.

8. The sample size for the training set

This section is Not Applicable. The device is a medical glove, not a machine learning model. Therefore, there is no "training set" in the context of AI. The described tests are for product verification and validation.

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

This section is Not Applicable. As stated above, there is no training set for this type of device.

Summary

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EXHIBIT #1 Page 1 of 2

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 §807.92.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

1. Submitter's Identification:

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

Date Summary Prepared: September 10, 1998

2. Name of the Device:

Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves

3. Predicate Device Information:

Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, K#964964

Cheer & Merit Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, K#942042

Device Description: 4 .

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

5. Intended Use:

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6. Comparison to Predicate Devices:

Shijiazhuang Great Eagle Plastic 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.

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

The standards used for Shijiazhuang Great Eagle Plastic Products Co., Ltd. glove production are based on ASTM-D-5250-All testing meets requirements for Physical 92. 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.

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

8. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic claim.

9. Conclusions:

Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves conform fully to ASTM-D-5250-92 standards 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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Image /page/2/Picture/1 description: The image is a black and white 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" written around it. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three lines representing snakes intertwined around a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 30 1998

Shijiazhuang Great Eagle Plastics Products Company, Ltd. C/O Ms. Susan Goldstein-Falk Official Correspondent Basic Medical Industries, Incorporated 13945 Magnolia Avenue 91710 Chino, California

K983207 Re : Synthetic Vinyl Powder-Free Patient Exam Trade Name: Gloves Requlatory Class: I Product Code: LYZ Dated: September 10, 1998 Received: September 14, 1998

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, Druq, 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. A 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 requlatory action. In addition, FDA may publish further announcements concerning your device in 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.

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Page 2 - Ms. Goldstein-Falk

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 requlation (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 ene organism or compiland, "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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510(k) Number (if known): K983207

Device Name: Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves-Powder-Free Indications For Use:

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)

Clim S. Lin

(Division Sign-Off) Division of Dental, Infection Collibl, and General Hospital Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

(Options) Formal 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.