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 800.6250, 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

This document describes the acceptance criteria and study proving the device meets those criteria, specifically for Shijiazhuang Dilly Plastics Products Co., Ltd. Synthetic Powdered Vinyl Patient Examination Gloves.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria	Reported Device Performance
Physical and Dimensions	ASTM-D-5250-92	Meets standard	Meets all requirements
Pinhole Detection	FDA 1000 ml. Water Fill Test	AQL 2.5, Inspection Level S-4	Meets requirements
Biocompatibility	Primary Skin Irritation	No primary skin irritant reactions	No primary skin irritant reactions
Biocompatibility	Skin Sensitization (allergic contact dermatitis)	No sensitization reactions	No sensitization reactions
General Compliance	Applicable 21 CFR references	Adherence to regulations	Conforms fully
Labeling Claims	Specific labeling claims	No special claims, not hypoallergenic	No special labeling claims, not claimed as hypoallergenic

2. Sample size used for the test set and data provenance:

Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. The specific number of gloves tested is not provided, but these AQL levels dictate the sampling plan. Data provenance is not explicitly stated beyond being conducted by the manufacturer, Shijiazhuang Dilly Plastics Products Co., Ltd.
FDA 1000 ml. Water Fill Test: Inspection Level S-4, AQL 2.5. The specific number of gloves tested is not provided, but these AQL levels dictate the sampling plan. Data provenance is not explicitly stated beyond being conducted by the manufacturer.
Primary Skin Irritation and Skin Sensitization: The document does not specify the sample size (e.g., number of subjects, number of tests) for these biocompatibility tests, nor does it explicitly state the country of origin or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Not Applicable. This document pertains to the 510(k) submission for patient examination gloves, which does not involve subjective diagnostic interpretations requiring expert consensus for ground truth establishment. The "ground truth" for these tests (e.g., pinhole presence, skin irritation) is based on objective measurements and established protocols.

4. Adjudication method for the test set:

Not Applicable. As the device is examination gloves and the tests are objective physical and chemical assessments, there is no need for an adjudication method in the context of expert review or consensus, such as 2+1 or 3+1.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. An MRMC comparative effectiveness study is not applicable for this type of device (patient examination gloves). These studies are typically used for diagnostic imaging devices where human readers interpret medical images, and the AI's impact on their performance is evaluated.

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

Not Applicable. This device is patient examination gloves, not an algorithm or AI system. Therefore, a standalone performance evaluation of an algorithm is not relevant.

7. The type of ground truth used:

The "ground truth" for the tests performed is based on:
- Objective measurements against established standards: For physical and dimensional properties, the ground truth is whether the glove meets the specifications of ASTM-D-5250-92.
- Objective experimental outcomes: For the pinhole test, the ground truth is whether water penetrates the glove under specified conditions. For biocompatibility, the ground truth is the presence or absence of a measurable irritating or sensitizing reaction.

8. The sample size for the training set:

Not Applicable. This documentation is for a physical medical device (examination gloves), not an AI/ML algorithm that requires a training set. The tests performed are quality control and performance verification tests for manufactured products.

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

Not Applicable. As there is no AI/ML algorithm or training set involved, the concept of establishing ground truth for a training set does not apply.

Summary

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SEP | 4 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: K99 24 loh

1. Submitter's Identification:

Ms. Xinglai Zhou Shijiazhuang Dilly Plastics Products Co., Ltd. No. 16, Zhi Nong Road, Shijaizhuang, Hebei Province P.R. China

Date Summary Prepared: July 14, 1999

2. Name of the Device:

Shijiazhuang Dilly 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 Dilly 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.

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

The standards used for Shijiazhuang Dilly 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.

8. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic Claim.

9. Conclusions:

Shijiazhuang Dilly 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 is a logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1999

Mr. Xinqlai Zhou General Manager Shijiazhuang Dilly Plastics Products Company, Ltd. No. 16, Zhi Nong Road Shijiazhuang, Hebei, China

K992464 Re : Synthetic Powered Vinyl Patient Examination Trade Name: Gloves Regulatory Class: I Product Code: LYZ ﺴﺘﺠﺮ ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، ، Dated: July 10, 1999 Received: July 23, 1999

Dear Mr. Zhou:

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 Druq 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 - Mr. Zhou

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 acborized in your lence of your device to a legally marketed predicate device results in a classification for your marked 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) 594-4690. 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 the regulacion chileted, "Hibbidhang &J" (break 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

Timo 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

Page 1 of 1
510(k) NUMBER (IF KNOWN) - Logg 24(of +
DEVICE NAME: Shijiazhuang Dilly Plasti Shijiazhuang Dilly 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)
Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter-Use(Optional Format 1-2-96)
(Division	(Division Sign-Off)
Division	Division of Dental, Infection Control,
and	and General Hospital Devices
510(k)	510(k) Number
	K992467

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.