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, Pre-powder 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 an analysis of the provided text to extract the acceptance criteria and study information, formatted as requested:

Device: SHANGHAI HUAMAO GLOVES CO., LTD. Pre-powder Vinyl Examination Gloves

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

Acceptance Criteria (Standard)	Reported Device Performance
ASTM Standard D5250-92	All testing meets requirements for Physical and Dimensions Testing, Inspection Level S-2, AQL 4.0. Conforms fully to ASTM D-5250-92 standards.
FDA 1000 ml. Water Fill Test	Samplings of AQL 2.5, Inspection Level S-4, meeting these requirements (pinhole FDA requirements).
Primary Skin Irritation	No primary skin irritant reactions.
Skin Sensitization (allergic contact dermatitis)	No sensitization reactions.
Compliance with FDA's GMPs	Operates in compliance with FDA's GMPs.
Bio-compatibility requirements	Met (as shown by data in Section 7).
Labeling claims	Met (as shown by data in Section 7).
Applicable 21 CFR references	Conforms fully.

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

Sample Size (Physical and Dimensions Testing): Not explicitly stated as a number, but "Inspection Level S-2, AQL 4.0" is mentioned, which refers to a sampling plan for inspection.
Sample Size (FDA 1000 ml. Water Fill Test): Not explicitly stated as a number, but "samplings of AQL 2.5, Inspection Level S-4" is mentioned, which refers to a sampling plan for inspection.
Data Provenance: The device manufacturer is SHANGHAI HUAMAO GLOVES CO., LTD. in Shanghai, China. The testing was conducted based on ASTM standards (likely in China or by a certified lab). It is implicitly retrospective as it's a premarket notification for a manufactured product.

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)

Not applicable. This device is a physical product (examination gloves), and its performance is evaluated against established technical standards (ASTM, FDA water fill test, biocompatibility). Expert consensus for "ground truth" in the way it's used for AI or diagnostic devices is not relevant here. The evaluation is based on objective measurements and tests.

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

Not applicable. Adjudication methods are typically for subjective assessments (e.g., medical image interpretation). The tests conducted here (physical dimensions, water fill, irritation, sensitization) are objective.

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

Not applicable. This is not a diagnostic device or an AI-assisted tool. It's a medical device (examination glove) with performance evaluated against industrial and regulatory standards.

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" in this context refers to the specified values and requirements set by the adopted standards:

ASTM Standard D5250-92: This standard defines the physical properties and dimensions for vinyl patient examination gloves.
FDA 1000 ml. Water Fill Test: This is a specific FDA requirement for assessing pinhole defects in gloves.
Biocompatibility Standards: These standards (implied, as "biocompatibility requirements" are mentioned) define acceptable levels of skin irritation and sensitization.

Essentially, the ground truth is defined by the established performance specifications and testing methodologies outlined in the regulatory and industry standards.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI models, so there is no training set. The "training set" concept is irrelevant for a physical product like examination gloves.

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

Not applicable, as there is no training set for this type of device.

Summary

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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

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 : K984461

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. Pre-powder Vinyl Examination Gloves

3. Predicate Device Information:

Shanghai Super Gloves Co., Ltd. #K974151

4. Device Description:

5.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.

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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. Pre-powder Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Shanghai Super Gloves Co., Ltd. Pre-powder 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.

SHANGHAI HUAMAO GLOVES CO., LTD. Operates in compliance with FDA's GMPs.

8. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic claim.

9.Conclusions:

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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, represented by three curved lines that suggest the bird's head and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 1999 FEB

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

Re: K984461 Pre-Powder-Free Vinyl Patient Examination Trade Name: Gloves Requlatory Class: I Product Code: LYZ December 14, 1998 Dated: 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 regulations 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) 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 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 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 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 qeneral 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

Timothy A. Ulatows Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Exhibit A

Page of

510(k) NUMBER (IF KNOWN):	K984461
DEVICE NAME:	SHANGHAI HUAMAO GLOVES CO., LTD. Pre-Powder Vinyl Patient 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) OR

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

Olin S. Lin

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