The Powder-Free Latex Examination Glove (green) with natural water soluble Vitamin E and Protein Labeling Claim(50 microgram or less per gram of glove) is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended for medical purpose that is worn on the examiner's hand or finger(s)to provide a barrier against potentially infectious materials and other contaminants. This device is not intended to be used as a chemical barrier.

Device Description

Class I powder free latex examination gloves (green) with natural water soluble Vitamin E and protein labeling claim(50 microgram or less), 80L Y Y, non-sterile meets all the requirements of ASTM standard D3578-01 and FDA 21 CFR 800.20.

AI/ML Overview

This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided 510(k) summary for "POWDER FREE LATEX EXAMINATIN GLOVES (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E AND PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS PER GRAM OF GLOVE)".

It's important to note that this is a medical device submission for examination gloves, not an AI/Software as a Medical Device (SaMD) submission. Therefore, many of the typical questions related to AI studies (like MRMC, training set details, expert qualifications for AI ground truth) are not applicable to this type of device. The focus here is on physical and chemical performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Standards / Acceptance Criteria	Device Performance
Dimensions	ASTM D 3578-01	Meets
Physical Properties	ASTM D 3578-01	Meets
Freedom from Pinholes	ASTM D 3578-01	Meets
Freedom from Pinholes	FDA 21 CFR 800.20	Meets
Powder Free	ASTM D 6124-97	<2 mg/glove
Protein Level	ASTM D5712-95	<50 microgram/gram
Biocompatibility: Primary Skin Irritation	Primary Skin Irritation In Rabbits	Passes
Biocompatibility: Dermal Sensitization	Dermal Sensitization	Passes

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Physical/Dimensional Testing: The document states that testing meets requirements for physical specifications and dimensions "conducted on gloves, Inspection level S-2, AQL 4.0, Pinholes at AQL 1.5". This indicates a sampling plan was used according to specific ASTM/FDA guidelines, but the exact number of gloves tested is not explicitly stated as a single number.
Data Provenance: The device is manufactured by Qingdao Bestex Rubber & Plastic Products Co. Ltd. in Qingdao, China. The testing would have been conducted by or for this manufacturer. The nature of these tests (material properties, biocompatibility) implies they are prospective tests performed on samples of the manufactured device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not Applicable. For examination gloves, "ground truth" is established by adherence to predefined, objective physical, chemical, and biological performance standards (e.g., tensile strength, protein content by specific assay, irritation in animal models). There are no human "experts" establishing a subjective ground truth in the way done for image interpretation in AI studies. The tests are performed according to established protocols by laboratory personnel.

4. Adjudication Method for the Test Set

Not Applicable. As mentioned above, "adjudication" in the context of expert consensus for subjective interpretations does not apply to this device. The results are objective measurements against established criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is not relevant for this type of medical device. These studies are typically used to assess the impact of AI on human reader performance in diagnostic tasks.

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

Not Applicable. This is a physical product (gloves), not an algorithm or software. Therefore, there is no "standalone algorithm performance" to assess.

7. The type of ground truth used

Objective Standards and Laboratory Test Results. The "ground truth" for this device is based on:
- Defined Standards: ASTM (American Society for Testing and Materials) standards (D 3578-01, D 6124-97, D5712-95) and FDA regulations (21 CFR 800.20).
- Laboratory Measurements: Quantitative measurements (e.g., protein content, powder content) and qualitative assessments (e.g., presence of pinholes, pass/fail for biocompatibility tests) performed according to these standards.
- Animal Models: Biocompatibility was assessed using "Primary Skin Irritation In Rabbits" and "Dermal Sensitization" tests, which are standard biological tests in animal models.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of this device. This is a manufactured product, not a machine learning model.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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OCT 1 5 2002

510(K) SUMMARY

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

POWDER FREE LATEX EXAMINATIN GLOVES (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E AND PROTEIN LABELING CLAIM(50 MICROGRAM OR LESS PER GRAM OF GLOVE

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, and prepared on Sep. 20, 2002

The assigned 510(K) number is KORQ5000

1.0 Submitter:

Oingdao Bestex Rubber & Plastic Products Co. Ltd. 14-2 Hangzhou Road, Pingdu., Oingdao, China

2.0 Regulatory Affairs Contact:

Name: ZeChuan Shao Phone No .: 408 980 1348 Fax No .: 408 980 1356

3.0 Name of device:

Undetermined Trade Name: Common Name: Examination Glove Classification Name: Patient Examination Glove, Powder Free

4.0 Identification of The Legally Marketed Device:

Class I patient examination gloves, 80L Y , non-sterile, powder free with natural water soluble Vitamin E that meets all the requirements of ASTM standard 3578-01 and FDA 21 CFR 800.20.

5.0 Device Description:

6.0 Intended Use of The Device:

The powder free latex examination glove (green) with natural water soluble Vitamin E nd protein labeling claim (50 microgram or less) is a disposable device made of natural rubber latex that may bear a trace arnount of glove powder and is intended for medical purposes that are worn on the examiner's hands or fingers to provide a barrier against potentially infectious materials and other contaminants.

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7.0 Summary of the Technological Characteristics of the Device:

The Powder Free Latex Examination Gloves (green) with natural water soluble Vitamin E and with Protein Content Labeling (50 micrograms or less) are summarized with the following technological characteristics compared to ASTM or equivalent standards:

Characteristics	Standards	Device Performance
Dimensions	ASTM D 3578-01	Meets
Physical Properties	ASTM D 3578-01	Meets
Freedom from	ASTM D 3578-01	Meets
Pinholes	FDA 21 CFR 800.20	Meets
Powder Free	ASTM D 6124-97	<2 mg/glove
Protein Level	ASTM D5712-95	<50 microgram/gram
Biocompatibility	Primary Skin Irritation In Rabbits	Passes
	Dermal Sensitization	Passes

8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data The standards used by Bestex Rubber & Plastic Products Co., Ltd. to determine substantial equivalence are based on ASTM 3578-01 AND FDA 21 CFR 800.20. All testing meets requirements for physical specifications and dimensions conducted on gloves, Inspection level S-2, AQL 4.0, Pinholes at AQL 1.5

Primary Skin Irritation and Skin Sensitization testing were also conducted with results meets all performance and biocompatibility requirements.

9.0 Substantial Equivalent Based on Assessment of Clinical Performance Data No new clinical test were conducted under this 510(K)

10.0 Other Information Deemed Necessary by FDA:

Not applicable.

Conclusion

The data presented indicate that the Powder Free Latex Examination Glove with water soluble natural Vitamin E and with a protein labeling claim (50 microgram or less) (green) meets ASTM standards, meet FDA pinhole requirements , biocompatibility requirements, and labeling claims. Consequently, this device is substantially equivalent to currently marketed devices.

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Image /page/2/Picture/1 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" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings and a human profile in the negative space.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2002

Mr. Zechuan Shao General Manager Bestex Protection Supply, Incorporated 2576 Lafayette Street Santa Clara, California 95050

Re: K022566

Trade/Device Name: Powder-free Latex Examination Glove, Green with Natural Water Soluble Vitamin E and Protein Content Labeling (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: 80 LYY Dated: July 31, 2002 Received: August 2, 2002

Dear Mr. Shao:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Mr. Shao

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Qingdao Bestex Rubber & Plastic Products Co., Ltd.

Add: 14-2, Hangzhou Road, Pingdao, China Tel: 0086 532 833339 Fax: 0086 532 8312027

Page 3 of 7

3.0 Indications for Use Statement:

INDICATIONS FOR USE

Applicant: Qingdao Bestex Rubber & Plastic Products Co., Ltd. 510(k) Number(if known): KO22510(0 Device Name: Powder-free latex examination glove (green) with natural water soluble Vitamin E and Protein content labeling (50 microgram or less)

Indications For Use:

This device is not intended to be used as a chemical barrier.

(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)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,

Infection Control, Dental D

510(k) Number. K022566

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.