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 a disposable device intended for A pacience chaminat is worn on the examinaer'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 Nitrile Patient Examination Glove, 80 LZA and meets all requirements of ASTM D3578-95.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Shanghai INTCO Plastic Rubber Products Co., Ltd. Synthetic Powderfree Nitrile Patient Examination Gloves:

Acceptance Criteria and Device Performance:

The provided document details the acceptance criteria based on established ASTM and FDA standards for patient examination gloves. The device is reported to meet these criteria.

Acceptance Criteria	Reported Device Performance
Material Standard: Conformance to ASTM D3578-95	The device "conforms fully to ASTM D-3578-95 standards."
Physical and Dimensions Testing: Meets requirements as per ASTM D3578-95, Inspection level S-2, AQL 4.0	"All testing meets requirements for physical and Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0."
Pinhole (Water Leak) Test: FDA 1000 ml. Water Fill test, AQL 2.5, Inspection Level S-4	"The FDA 1000 ml. Water Fill test was also conducted with samplings of AQL 2.5, Inspection Level S-4, meeting these requirements." and "meets pinhole FDA requirements."
Biocompatibility - Primary Skin Irritation: No primary skin irritant reactions	"Primary Skin Irritation...testing was conducted with results showing no primary skin irritant...reactions."
Biocompatibility - Skin Sensitization (Allergic Contact Dermatitis): No sensitization reactions	"Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no...sensitization reactions."
Powder Content: Negative result on USP Iodine Test (absence of powder)	"The USP Iodine Test has been employed to show that no powder is used in the process (negative results)."
Labeling Claims: No special labeling claims, no 'hypoallergenic' claim	"There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels." and "meets...labeling claims as shown by data in Section 7."
Regulatory Conformance: Conforms to applicable 21 CFR references (e.g., 21 CFR 880.6250)	"conform fully to...applicable 21 CFR references."

Study Details:

It's important to note that this submission is for a medical device (patient examination gloves), and the "study" here refers to the non-clinical and "clinical" (biocompatibility) tests performed to demonstrate substantial equivalence to predicate devices, rather than a clinical trial in the traditional sense for diagnostic or therapeutic devices.

Sample size used for the test set and the data provenance:
- Physical and Dimensions Testing: "Inspection level S-2, AQL 4.0" (The exact number of units sampled is not specified but is determined by the AQL and inspection level from ASTM tables).
- FDA 1000 ml. Water Fill test: "samplings of AQL 2.5, Inspection Level S-4" (Again, the exact number is not explicitly stated but is derived from the AQL and inspection level).
- Primary Skin Irritation and Skin Sensitization: The number of subjects or samples for these biocompatibility tests is not provided in the summary.
- Data Provenance: The tests were conducted by the manufacturer, Shanghai INTCO Plastic Rubber Products Co., Ltd. The document does not specify country of origin for the samples, but implies they are from their manufacturing process in China. These tests are retrospective to the submission date.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not directly applicable in the context of device testing for examination gloves. The "ground truth" is established by adherence to the objective, predefined criteria and methodologies within the ASTM and FDA standards themselves for physical properties, dimensions, and biocompatibility. There isn't a "ground truth" established by human experts in the same way there would be for an AI diagnostic device evaluating images. Testing is performed by qualified laboratory personnel following strict protocols.
Adjudication method for the test set:
- Not applicable. Testing is objective and follows standardized protocols. Results are compared directly to the specified acceptance criteria of ASTM D3578-95 and FDA guidelines, not against expert consensus.
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 device is a manual medical device (examination glove), not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study or AI assistance is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an algorithm-based device.
The type of ground truth used:
- The "ground truth" for this device's performance is the adherence to established industry standards (ASTM D3578-95) and regulatory requirements (FDA 1000 ml. Water Fill test, 21 CFR, biocompatibility guidelines). This is a form of objective measurement against predefined specifications.
The sample size for the training set:
- Not applicable. This is not a device that utilizes machine learning and therefore does not have a "training set." The manufacturing process itself (e.g., using a polyurethane coating instead of powder) is designed to meet criteria, not "trained."
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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K9 40186

Attachment #2 Page 1 of 2

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: K990186

1. Submitters Identification:

Mr. Fang Yi Liu Shanghai INTCO Plastic Rubber Products Co., Ltd. 1097 Pu Dong Dai Road Bldg. 2 Suite 20-E Shanghai, P.R. China 2000135

Date Received: January 20, 1999 Request for Additional Informaiton: April 14, 1999

2. Name of the Device:

Shanghai INTCO Plastic Rubber Products Co., Ltd. Synthetic Powderfree Nitrile Patient Examination Gloves

3. Predicate Device Information:

UniSeal, American Healthcare, Powder-Free Nitrile Patient Examination Gloves, K#982218. Besglove Medicare, Powder-Free Nitrile Patient Examination Gloves, K#981878

Device Description: 3.

Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80 LZA and meets all requirements of ASTM D3578-95.

4. Intended Use:

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K990186

Attachment #2 Page 2 of 2

5. Comparison to Predicate Devices:

Shanghai INTCO Plastic Rubber Products Co., Ltd. Synthetic Powderfree Nitrile Patient Examination Gloves, are substantially equivalent in safety and effectiveness to the Ansell Edmont Powderfree Nitrile Patient Examination Gloves and the American Healthcare Patient Examination Gloves.

6. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The standards used for Shanghai INTCO Plastic Rubber Products Co., Ltd. glove production are based on ASTM-D3578-95. 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.

Our manufacturing process has no powder introduced at any stage in the process, as we use a polyurethane coating as a donning agent. The USP Iodine Test has been employed to show that no powder is used in the process (negative results).

7. Discussion of Clinical Tests Performed:

Not Applicable - there is no hypoallergenic claim.

8. Conclusions:

Shanghai INTCO Plastic Rubber Products Co., Ltd. Synthetic Nitrile Examination Gloves conform fully to ASTM D-3578-95 standards 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 1999

Shanghai INTCO Plastic Rubber Products Company, Ltd. c/o Ms. Karen E. Abell Official Correspondent Basic Medical Industries, Incorporated 13945 Maqnolia Avenue Chino, California 91710

K990186 Re: Synthetic Powder-Free Nitrile Patient Trade Name: Examination Gloves Regulatory Class: I Product Code: LZA April 22, 1999 Dated: Received: May 7, 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, qood 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) 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Paqe 2 - Ms. Abell

this response to your premarket notification Please note: 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 requlations.

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 requlation 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.fdaggov/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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Attachment A

Page of

510(k) Number (if known):_ K 990 | 8 (6 ) 0 | 8 | 0 |

Device Name: Shanghai INTCO Plastic Rubber Products Co., Ltd.

Synthetic Powderfree Nitrile Patient Examination Gloves Indications For Use:

A patient examination glove is a disposable device intended for A pacience chaminat is worn on the examinaer's hand or finger to prevent contamination between patient and examiner.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use X

(Optional Format 1-2-96). . .

Chin S. Lin

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