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 regarding acceptance criteria and study data:

This document is a 510(k) summary for pre-powdered vinyl examination gloves. Medical gloves, in general, are low-risk devices (Class I) and do not typically involve the complex AI/ML-driven analyses you're asking about. Therefore, many of your questions about AI study specifics (effect size of AI assistance, MRMC studies, training set details) are not applicable to this type of device and submission.

The "acceptance criteria" here refer to meeting established industry standards for the physical properties and safety of medical gloves, rather than performance metrics for an AI algorithm.

Acceptance Criteria and Reported Device Performance

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

Acceptance Criteria (Standard)	Reported Device Performance (Compliance)
ASTM D-5250-92 (Physical & Dimensions)	Meets all requirements for Physical and Dimensions Testing (Inspection Level S-2, AQL 4.0)
FDA 1000 ml. Water Fill Test (Pinhole integrity)	Meets requirements (AQL 2.5, Inspection Level S-4)
Primary Skin Irritation Test	Results showing no primary skin irritant reactions
Skin Sensitization Test (Allergic Contact Dermatitis)	Results showing no sensitization reactions
FDA's GMPs (Quality System)	Operates in compliance with FDA's GMPs
21 CFR 880.6250 (Pre-powder Vinyl Patient Examination Glove)	Classified as Class I and meets requirements
21 CFR (General controls, labeling, etc.)	Conforms fully to applicable 21 CFR references and labeling claims

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

Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. The exact sample size is not explicitly stated but is determined by the AQL (Acceptance Quality Limit) and inspection level, which refers to a sampling plan from industry standards.
FDA 1000 ml. Water Fill Test: AQL 2.5, Inspection Level S-4. The exact sample size is not explicitly stated but is determined by the AQL and inspection level.
Primary Skin Irritation and Skin Sensitization Testing: The sample size for these biocompatibility tests is not explicitly stated in the summary.
Data Provenance: Not specified, but generally, these tests would be conducted by the manufacturer's quality control or a third-party testing lab. The submission is from Shanghai Chinastar Corp. in Shanghai, China. The testing would have been done prior to the 1999 submission date. These are non-clinical, lab-based tests.

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 medical device for general use (gloves), not an AI/ML diagnostic or predictive device requiring clinical expert interpretation to establish ground truth for its performance. The "ground truth" for glove performance is adherence to physical specifications and biocompatibility standards measured by laboratory methods.

4. Adjudication method for the test set

N/A. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpreting clinical data for devices where human interpretation of medical images or symptoms is central to establishing ground truth. This is not relevant for glove testing.

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 not an AI-assisted device.

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

N/A. This is not an AI algorithm.

7. The type of ground truth used

For this device, the "ground truth" is defined by:

Standard Specifications: Adherence to ASTM D-5250-92 for physical properties (e.g., dimensions, tensile strength, elongation).
Performance Tests: Results from the FDA 1000 ml. Water Fill Test for pinhole integrity.
Biocompatibility Testing: Results from Primary Skin Irritation and Skin Sensitization tests.
Regulatory Compliance: Conformance to FDA Good Manufacturing Practices (GMPs) and relevant 21 CFR regulations.

8. The sample size for the training set

N/A. There is no AI/ML model for this device that would require a training set. The device's characteristics are determined by manufacturing processes and raw materials, not by learning from data.

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

N/A. See above.

Summary

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IANGHAI CHINASTAR CO

NO. 283, CHE XIN ROAD, CHE DUN ZHEN, SONG JIANG COUNTY, SHANGHAI, CHINA C/O: 11F, 201, NANKING E. RD., SEC 3, TAIPEI, TAIWAN, R.O.O. TFL/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.

Kag 2205 The assigned 510(k) number is:

1.Submitter's Identification:

Mr. LEE HUNG TE CHIH SHANGHAI CHINASTAR CORP. No. 283, Che Xing Road, Che Dun Zhen, Song Jiang County

Date Summary Prepared: 25 May 1999

2. Name of the Device:

SHANGHAI CHINASTAR CORP. Pre-powdered Vinyl Examination Gloves

3. Predicate Device Information:

Shanghai Huamao Gloves Co., Ltd. #K984461

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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HANGHAI CHINASTA

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

6. Comparison to Predicate devices:

SHANGHAI CHINASTAR CORP. Pre-powdered Vinyl Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Shanghai Super Gloves Co., Ltd. Prepowdered 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.

SHANGHAI CHINASTAR CORP. Operates in compliance with FDA's GMPs.

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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and head. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 23 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

Re : K992205 Pre-Powdered Vinyl Patient Examination Trade Name: Gloves Requlatory 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 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 Title 21, Parts 800 to 895. Federal Regulations, ਸੈ 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.

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Page 2 - Ms. Goldstein-Falk

Please note: this response to your 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 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 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.fdaggov/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 _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): _ K 99220 ک

SHANGHAI CHINASTAR CORP. Device Name: 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)

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)

Clint Sulin

(Division Sign-Off)
Division of Dental, Infection Control,
soodGeneral Hospital Devices
510(k) Number
K992205

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.