A patient examination glove is a disposable device intended for medical purposes that is worr 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 Vinyl Patient Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the SHANGHAI HUAMAO GLOVES CO., LTD. Powder-free Vinyl Patient Examination Gloves:

The document is a 510(k) summary for a medical device submitted to the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with strict acceptance criteria and performance metrics in the typical sense of a clinical trial. However, we can extract the relevant information regarding the standards and tests performed.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Standard	Reported Device Performance
ASTM D5250-92 manufacturing requirements (Physical and Dimensions Testing)	Meets all requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0.
FDA 1000 ml. Water Fill Test (for pinholes)	Meets requirements with samplings of AQL 2.5, Inspection Level S-4.
Primary Skin Irritation	No primary skin irritant reactions.
Skin Sensitization (allergic contact dermatitis)	No sensitization reactions.
USP Iodine Test for Starch	Meets "powder-free" claim (conducted at finished inspection).
"Powder residue by weight" testing	Adheres to USP Iodine Test methodology.
Particulate testing	Contracting with a laboratory for added assurance (implies intent to meet standards, but specific results not reported here).
Light Transmission Test	Final release testing consists of this (implies meeting internal criteria, but specific criteria/results not detailed).
Applicable 21 CFR references	Conforms fully.

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

Sample Size:
- For ASTM D5250-92 Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. (Specific number of units tested is not provided, but these are standard sampling plans.)
- For FDA 1000 ml. Water Fill Test: Inspection Level S-4, AQL 2.5. (Specific number of units tested is not provided.)
- For Primary Skin Irritation and Skin Sensitization: Not specified, but generally involves a set number of human subjects or animal models according to standard protocols.
- For USP Iodine Test/Powder Residue/Light Transmission: Conducted at finished inspection and final release; specific sample sizes for these internal quality control tests are not provided in this summary.
Data Provenance: The device is manufactured by SHANGHAI HUAMAO GLOVES CO., LTD. in Shanghai, China. The testing was presumably conducted by or for the manufacturer. The data is retrospective in the sense that it summarizes tests already performed on manufactured batches.

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

This document does not describe a scenario where experts established ground truth in the context of a typical diagnostic or AI study. The "ground truth" here is defined by meeting established regulatory standards (ASTM, FDA water fill test, USP, biocompatibility tests). These standards have predetermined pass/fail criteria, often implemented by trained technicians or quality control personnel in a laboratory setting. There isn't a "consensus of experts" forming a ground truth here.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective measurements against defined standards (e.g., AQL levels for defects, specific chemical tests, physical property limits). There is no "adjudication" between multiple expert opinions, as the assessment is based on direct measurement against a standard.

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

No, an MRMC comparative effectiveness study was not done. This device is a Class I medical device (patient examination gloves) and the submission focuses on demonstrating substantial equivalence through performance against established material and safety standards, not on evaluating human reader performance with or without AI assistance.

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

Not applicable. This is not an AI/algorithm-driven device. The "performance" is the physical and chemical properties of the gloves themselves.

7. The Type of Ground Truth Used

The ground truth is based on regulatory standards and established test methodologies (e.g., ASTM D5250-92 for physical properties, FDA 1000 ml. Water Fill Test for barrier integrity, USP Iodine Test for powder content, and biocompatibility standards for skin irritation/sensitization). These are objective, measurable criteria.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set" in that context. The "training" in manufacturing refers to adherence to good manufacturing practices and quality control processes to ensure consistency.

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

Not applicable, as there is no training set for an AI model. The manufacturing process itself (which could be loosely considered "training" if one were to stretch the analogy) is validated by adhering to established quality management systems (like GMP - Good Manufacturing Practice, mentioned in the FDA letter). The ground truth for successful manufacturing is producing gloves that consistently meet the specifications outlined in the standards (ASTM, FDA, USP, etc.).

Summary

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FEB - 9 1999

球网

SHANGHAI HUAMAO GLOVES CO., LTD.

No. 8, New Industrial Area, Zhu Hang Zhen, Jin Shan County, Shanghai, China C/O: Room C, 11F, 201, Nanking E Rd., Sec. 3, Taipei, Taiwan, R.O.C. Tel/Fax: 886-2-2712-5051

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 : K984460

1.Submitter's Identification:

Mr. Hsieh, I-shih SHANGHAI HUAMAO GLOVES CO., LTD. No. 8, New Industrial Area, Zhu Hang Zhen, Jin Shan County, Shanghai, China

Date Summary Prepared: 27 November 1998

2. Name of the Device:

SHANGHAI HUAMAO GLOVES CO., LTD. Powder-free Vinyl Patient Examination Gloves

3. Predicate Device Information:

Shanghai Super Gloves Co., Ltd. #K974120

4. Device Description:

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

5.Intended Use:

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SHANGHAI HUAMAO GLOVES CO., LTD.

No. 8, New Industrial Area, Zhu Hang Zhen, Jin Shan County, Shanghai, China C/O: Room C, 11F, 201, Nanking E Rd., Sec. 3, Taipei, Taiwan, R.O.C. Tel/Fax: 886-2-2712-5051

6. Comparison to Predicate devices:

SHANGHAI HUAMAO GLOVES CO., LTD. Powder-free Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Shanghai Super Gloves Co., Ltd. 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 SHANGHAI HUAMAO GLOVES CO., LTD. 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" claim. We adhere to all USP lodine Test methodology and testing "powderresidue by weight" and are contracting with a laboratory to conduct particulate testing for added assurance. Final release testing consists of a light transmission test using a spectrophotometer.

8.Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic claim.

9.Conclusions:

11:11

SHANGHAI HUAMAO GLOVES CO., LTD. Vinyl Patient Examination Gloves conform fully to ASTM D-5250-92 standards as well as applicable 21 CFR references, and meets pinhole FDA requirements, bio-compatibility 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 Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the upper half of the circle. Inside the circle is a stylized symbol that resembles three overlapping human profiles facing to the right. The symbol is rendered in black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 1999

Shanghai Huamao Gloves Co. Ltd. C/O Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

K984460 Re : Powder-Free Vinyl Patient Examination Gloves Trade Name: Regulatory Class: I Product Code: LYZ Dated: December 14, 1998 Received: December 16, 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, 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 requlations 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) 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 requlation 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 premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Goldstein-Falk

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,

Timothy A. Ulatowski

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit A

Page 1 ot

510(k) NUMBER (IF KNOWN): K984460

SHANGHAI HUAMAO GLOVES CO., LTD. Powder-free Vinyl Patient DEVICE NAME: Examination Gloves 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.)

Concurrent of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use $\underline{X}$
(Optional Format 1-2-96)

Olin Si Lim

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