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, 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 the study proving the device meets them, structured as requested:

Device: Shijiazhuang Dilly Plastics Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves

Acceptance Criteria and Device Performance:

Acceptance Criteria	Reported Device Performance
Conformance to ASTM Standard 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 requirements (Pinhole integrity)	"The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements."
Biocompatibility (Primary Skin Irritation and Skin Sensitization)	"Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions."
"Powder-free" claim (USP Iodine Test for Starch)	"A USP Iodine Test for Starch at finished inspection is conducted to insure that our gloves meet our 'powder-free' claims. We adhere to all USP Iodine test methodology and testing conducted revealed passing results."
General controls provisions of the Medical Device Amendments (e.g., annual registration, listing of devices, good manufacturing practice, labeling, prohibitions against misbranding and adulteration)	The FDA's 510(k) clearance letter states, "You may, therefore, market the device, subject to the general controls provisions of the Act." This implies the device is deemed to comply or is expected to comply with these provisions.

Study Details:

Sample size used for the test set and the data provenance:
- ASTM D5250-92 Physical and Dimensions Testing: "Inspection Level S-2, AQL 4.0." (Specific sample size not explicitly stated, but determined by the AQL level for lots.)
- FDA 1000 ml. Water Fill Test: "AQL 2.5, Inspection Level S-4." (Specific sample size not explicitly stated, but determined by the AQL level for lots.)
- Primary Skin Irritation and Skin Sensitization Testing: Not explicitly stated.
- USP Iodine Test for Starch: Not explicitly stated.
- Data Provenance: The document implies in-house testing conducted by Shijiazhuang Dilly Plastics Products Co., Ltd. in P.R. China, presumably on newly manufactured gloves. This would be considered prospective for the specific batches tested.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document describes performance against established industry standards (ASTM D5250-92) and FDA test methods (1000 ml. Water Fill Test, USP Iodine Test), as well as biocompatibility testing. It does not mention expert consensus for establishing ground truth in the context of diagnostic interpretation. Ground truth for these criteria is defined by the objective pass/fail parameters outlined in the respective standards and test methodologies.
Adjudication method for the test set:
- No adjudication method (like 2+1, 3+1) is mentioned as this is not a study involving subjective interpretations (e.g., image reading). The tests are objective measurements against defined criteria in standards.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical examination glove, not an AI-powered diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical product and does not involve an algorithm.
The type of ground truth used:
- The ground truth for the performance criteria is based on objective, standardized measurements and pass/fail criteria defined by ASTM D5250-92, FDA test methods (e.g., 1000 ml. Water Fill Test, USP Iodine Test), and general biocompatibility testing protocols.
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that context. The "training" here would be for the manufacturing process to consistently produce compliant gloves.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the AI sense. The manufacturing process is designed and controlled to meet the established performance standards.

Summary

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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: K992463

1. Submitter's Identification:

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

Date Summary Prepared: July 10, 1999

2. Name of the Device:

Shijiazhuang Dilly Plastics 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

4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 800.6250, Powder-Free Vinyl Patient 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 Dilly Plastics 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 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.

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

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 (Powder-Free) 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/10 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 30 1999

Mr. Xinqlai Zhou General Manager Shijiazhuang Dilly Plastics Products Co., Ltd. NO. 16, Zhi Nong Road, Shijiazhuang, Hebei Province P.R. CHINA

K992463 Re : Synthetic Powder-Free Vinyl Patient Trade Name: Examination Gloves Requlatory Class: I Product Code: LYZ Dated: July 15, 1999 Received: July 23, 1999

Dear Mr. Xinglai 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 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 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 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

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Page 2 - Mr. Xinglai Zhou

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 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 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

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

ーズ

510(k) NUMBER (IF KNOWN): K992463
DEVICE NAME: Shijiazhuang Dilly Plastics Products Co., Ltd.
INDICATIONS FOR USE: Synthetic Powder Free Vinyl Patient Examination Gloves-Powder Free

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
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Approved for C. Lin

(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number	KGG 2463
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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.