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 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

Here's a breakdown of the acceptance criteria and study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Compliance with ASTM Standard D5250-92 for Physical and Dimensions Testing	Meets all requirements of ASTM Standard D5250-92
FDA 1000 ml. Water Fill Test (AQL 2.5, Inspection Level S-4)	Meets requirements
Primary Skin Irritation	No primary skin irritant reactions
Skin Sensitization (allergic contact dermatitis)	No sensitization reactions
Pinhole FDA requirements	Meets pinhole FDA requirements

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., Physical and Dimensions, Water Fill, Biocompatibility). It mentions:

Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0
FDA 1000 ml. Water Fill Test: AQL 2.5, Inspection Level S-4

The data provenance is implied to be from Shijiazhuang Hongxiang Plastics Products Co., Ltd. in P.R. China, based on their testing of their own product. The studies appear to be retrospective in the sense that they were conducted on already manufactured products to ensure compliance.

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

This information is Not Applicable to this submission. The device is a patient examination glove, and the "ground truth" for its performance is established through standardized physical, chemical, and biological tests, not through expert interpretation of data like in medical imaging.

4. Adjudication Method for the Test Set

This information is Not Applicable as the ground truth is established through objective, standardized tests, not through subjective human interpretation requiring adjudication.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for comparing the performance of human readers with and without AI assistance, typically in diagnostic tasks. This device is a medical glove, which doesn't involve diagnostic reading.

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

This information is Not Applicable. The device is a physical product (a glove), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm doesn't apply.

7. The Type of Ground Truth Used

The ground truth used for assessing this device's performance is based on standardized test specifications (ASTM D5250-92 and FDA Water Fill Test requirements) and biological test results (primary skin irritation and skin sensitization).

8. The Sample Size for the Training Set

This information is Not Applicable. There is no "training set" in the context of this device. The manufacturer produces a product and tests it against established standards. This is not an AI/machine learning model that requires training data.

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

This information is Not Applicable for the reasons stated in point 8.

Summary

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NOV - 5 1999

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:

1. Submitter's Identification:

Ms. Guixi Liu Shijiazhuang Hongxiang Plastics Products Co., Ltd. Lu Quan City, New High Technologies Industrial Zone Shijaizhuang, Hebei Province P.R. China

Date Summary Prepared: July 29, 1999

Name of the Device: 2. -

Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic Powdered Vinyl Patient Examination Gloves

3. Predicate Device Information:

Sunmax Enterprise Shanghai Co., Ltd. Powdered Vinyl Patient Examination Gloves, K#960746 Shanghai Super Gloves Company, Ltd. Powdered Vinyl Patient Examination Gloves, K#974151

4. Device Description:

5. Intended Use:

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6. Comparison to Predicate Devices:

Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic Powdered Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Sunmax Enterprise Shanghai Co., Ltd. Powdered Vinyl Patient Examination Gloves and the Shanghai Super Gloves Company, Ltd. Powder Vinyl Patient Examination Gloves.

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

The standards used for Shijiazhuang Hongxiang 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.

Discussion of Clinical Tests Performed: 8.

Not Applicable - There is no hypoallergenic Claim.

9. Conclusions:

Shijiazhuang Hongxiang Plastics Co., Ltd. Synthetic Vinyl Patient Examination gloves (Powdered) 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 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three birds in flight, arranged in a stacked formation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 1999

Shijiazhuang Hongxiang Plastics Products Co., Ltd. c/o Ms. Karen Abell Official Correspondent for Shijiazhuang Hongxiang Plastics Products Co., Ltd. Basic Medical Industries, Inc. 12390 East End Avenue Chino, California 91710

Re : K992797 Synthetic Powdered Vinyl Patient Examination Trade Name: Gloves Regulatory Class: I . . . . Product Code: LYZ Dated: July 29, 1999 Received: August 19, 1999

Dear Ms. Abell:

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 aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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

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Page 2 - Ms. Abell

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 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 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,

Kilitaturski
Timothy A. Ulatowski

thy 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

(IF KNOWN) : _ 510(k) NUMBER

Shijiazhuang Hongxiang Plastics Products Co., Ltd. DEVICE NAME: INDICATIONS FOR USE: Synthetic Powdered Vinyl Patient Examination Gloves-Powdered

A patient examination glove is 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.)

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)

(Division Sign-Off)
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Division of Dental, Infection Control,
and General Hospital Devices

510(k) Number	K992797
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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.