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 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 a breakdown of the acceptance criteria and study information for the SHANGHAI CHINASTAR CORP. Powder-free Vinyl Patient Examination Gloves, based on the provided text:

Important Note: This document describes a medical device, but it is not an AI/ML device. Therefore, many of the requested fields related to AI performance, ground truth, expert consensus, and training/test sets are Not Applicable (N/A) for this type of product. The acceptance criteria focus on physical properties, biocompatibility, and regulatory compliance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Physical and Dimensions Testing (based on ASTM D-5250-92)	All testing meets requirements for Physical and Dimensions Testing
Inspection Level S-2, AQL 4.0	Meets requirements
FDA 1000 ml Water Fill Test	Meets requirements
Inspection Level S-4, AQL 2.5	Meets requirements
Primary Skin Irritation Testing	No primary skin irritant reactions
Skin Sensitization (allergic contact dermatitis) Testing	No sensitization reactions
Powder-free claim (USP Iodine Test for Starch)	Adheres to all USP Iodine Test methodology; meets "powder-free" claim
Powder residue by weight	Adheres to all USP Iodine Test methodology
Particulate testing	Contracting with a laboratory for added assurance
Final release testing (Light transmission test using spectrophotometer)	Conducted
Pinhole requirements	Meets FDA requirements
Biocompatibility requirements	Meets requirements
Labeling claims	Meets requirements
Conformity to ASTM D-5250-92 standards	Conforms fully
Conformity to applicable 21 CFR references	Conforms fully

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

Sample Size for Test Set:
- For Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. The exact number of units is not specified, but this AQL (Acceptable Quality Level) implies a sampling plan.
- For FDA 1000 ml Water Fill Test: Inspection Level S-4, AQL 2.5. The exact number of units is not specified, but this AQL implies a sampling plan.
- For Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but clinical testing was conducted.
- For USP Iodine Test: Not explicitly stated, but conducted on "finished inspection."
Data Provenance: Not explicitly stated, but the manufacturing company is based in Shanghai, China, suggesting the testing was performed there or by associated labs. The testing is retrospective in the sense that it's performed on manufactured products to ensure quality and compliance.

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

N/A. This is a non-AI device. Ground truth for a glove focuses on objective measurements and established standards (e.g., tensile strength, dimensional accuracy, water leak tests, chemical composition). Expert consensus, in the sense of clinical interpretation, is not relevant here.

4. Adjudication method for the test set

N/A. As this is a non-AI device, there's no "adjudication" in the context of expert review for ambiguous cases. The testing involves standardized procedures and objective measurements that either meet or do not meet predefined criteria.

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

N/A. This is a non-AI device. MRMC studies are not applicable.

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

N/A. This is a non-AI device.

7. The type of ground truth used

The "ground truth" for this device constitutes objective, measurable standards and specifications defined by regulatory bodies (FDA) and industry standards (ASTM D-5250-92). This includes:
- Objective Measurements: Physical dimensions, tensile strength, elongation, force at break (implied by ASTM D-5250-92).
- Pass/Fail Tests: Water leak test (FDA 1000 ml Water Fill Test), USP Iodine Test for starch, primary skin irritation, skin sensitization.
- Chemical Analysis: Ensuring "powder-free" status and absence of sensitizing agents.

8. The sample size for the training set

N/A. This is a non-AI device; there is no "training set."

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

N/A. This is a non-AI device; there is no "training set."

Summary

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AI CHINA

NO. 283, CHE XIN ROAD, CHE DUN ZHEN, SONG JIANG COUNTY C/O: 11F, 201, NANKING E. RD., SEC 3, TAIPEI, TAIWAN, R.C. TEL/FAX: 886-2-27171298

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: _ (Cag 220)

1.Submitter's Identification:

Mr. LEE HUNG TE CHIH SHANGHAI CHINASTAR CORP. No. 1, Rong Xing Road, Che Dun Zhen, Song Jiang County Shanghai, China

Date Summary Prepared: 25 May 1999

2. Name of the Device:

SHANGHAI CHINASTAR CORP. Powder-free Vinyl Patient Examination Gloves

3. Predicate Device Information:

Shanghai Huamao Gloves Co., Ltd. #K984460

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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ROAD, CHE DUN ZHEN, SONG JIANG C/O: 11F, 201, NANKING E. RD., SEC 3, TAIPEI, T TEL/FAX: 886-2-27171298

6. Comparison to Predicate devices:

SHANGHAI CHINASTAR CORP. 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 CHINASTAR CORP. 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 Iodine 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 not hypoallergenic claim.

9.Conclusions:

SHANGHAI CHINASTAR CORP. 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 is a black and white 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 with three curved lines extending from its head, resembling feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 29 1999

Shanghai Chinastar Corporation c/o Ms. Susan D. Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

K992206 Re : Powder-Free Vinyl Patient Examination Gloves Trade Name: Regulatory Class: I Product Code: LYZ June 28, 1999 Dated: Received: June 30, 1999

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. ਸਿ 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.

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Page 2 - Ms. Goldstein-Falk

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 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 ene regaracion cheroids, ".ISER 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 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

510(k) Number (if known): 长99 220 (o

SHANGHAI CHINASTAR CORP. Device Name: Powder-Free Vinyl Patient Examination Gloves

Indications For Use:

A patient examination glove is a disposable device intended for medical A parient oxamined.com 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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

Chin S. Lin

(Division Sigmentul Infection Control,
on
Division of Dentsplan 000 Control,
and General Hospital Devices
510(k) Number K992206

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.