The Powder-Free Latex Examination Glove with Aloe Vera, natural water soluble Vitamin E and C and with 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 with Aloe Vera, natural water soluble Vitamin E and C and protein labeling claim(50 microgram or less), 80LYY, nonsterile meets all the requirements of ASTM standard D3578-01 and FDA 21 CFR 800.20.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Powder Free Latex Examination Gloves

This report details the acceptance criteria and the study that proves the performance of the "Powder Free Latex Examination Glove with Aloe Vera, Natural Water Soluble Vitamin E and C, and Protein Content Labeling (50 Microgram or Less)" by Qingdao Bestex Rubber & Plastic Products Co., Ltd. (K042645).

1. Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against established ASTM standards and FDA regulations. The following table summarizes the acceptance criteria and the reported performance of the device:

Characteristics	Standards	Acceptance Criteria (Implied by "Meets" or specified values)	Device Performance
Dimensions	ASTM D 3578-01	Meets ASTM D 3578-01 requirements	Meets
Physical Properties	ASTM D 3578-01	Meets ASTM D 3578-01 requirements	Meets
Freedom from Pinholes	ASTM D 3578-01	Meets ASTM D 3578-01 requirements	Meets
	FDA 21 CFR 800.20	Meets FDA 21 CFR 800.20 requirements	Meets
Powder Free	ASTM D 6124-01	<2 mg/glove	<2 mg/glove
Protein Level	ASTM D5712-99	<50 microgram/gram	<50 microgram/gram
Biocompatibility	Primary Skin Irritation In Rabbits	Passes	Passes
	Dermal Sensitization	Passes	Passes

2. Sample Size and Data Provenance

Test Set Sample Size:
- Physical Specifications and Dimensions: Inspection level S-2, AQL 4.0. The exact number of gloves tested is not explicitly stated, but "Inspection level S-2" refers to a specific sampling plan within ASTM/ISO standards, which dictates the sample size based on the lot size.
- Pinholes: AQL 1.5. Similar to the above, the exact number is not explicitly stated, but AQL 1.5 implies a specific sampling plan.
- Powder Free Tests (ASTM D 6124-01) and Protein Level (ASTM D5712-99): The specific sample sizes for these tests are not explicitly mentioned in the provided text.
- Biocompatibility (Primary Skin Irritation and Dermal Sensitization): Not specified in the provided text, but typically involves a documented number of animal subjects (e.g., rabbits for primary skin irritation).
Data Provenance: The studies were conducted by Qingdao Bestex Rubber & Plastic Products Co., Ltd., which is located in China. The data would therefore be considered retrospective as it was collected and analyzed as part of the submission process, and likely performed in laboratory settings.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. The ground truth for this device's performance is based on objective measurements and established standards, not expert interpretation of qualitative data.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, measurable tests against established standards (e.g., physical dimensions, tensile strength, pinhole count, chemical assays for powder and protein, animal biocompatibility studies). There is no "adjudication" in the sense of multiple human reviewers reaching a consensus on a subjective outcome.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a medical glove, and its effectiveness is determined by its physical and chemical properties as a barrier, not by human interpretation or diagnostic accuracy in comparison to AI assistance.

6. Standalone Performance Study

Yes, a standalone study was performed. The device's performance was evaluated independently against the specified ASTM standards and FDA regulations without human-in-the-loop performance being a factor. This means the algorithm (or the glove's inherent design and manufacturing) was directly tested against objective criteria.

7. Type of Ground Truth Used

The ground truth used for these studies is based on:

Established Standards: ASTM D 3578-01, ASTM D 6124-01, ASTM D5712-99, and FDA 21 CFR 800.20. These standards define the acceptable range or threshold for specific physical, chemical, and biological properties.
Objective Measurements: Laboratory tests and measurements were conducted to quantify the device's characteristics against these standards (e.g., measuring dimensions, counting pinholes, chemical analysis for powder and protein, observing animal reactions for biocompatibility).

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The manufacturing process is refined through quality assurance, but there isn't a "training set" like in software development.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of this physical medical device. The "ground truth" for manufacturing quality and process control would be established through adherence to Good Manufacturing Practices (GMP) and ongoing quality control checks, ensuring that each batch meets the established specifications based on the ASTM and FDA standards.

Summary

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NOV 2 6 2004

510(K) SUMMARY

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

POWDER FREE LATEX EXAMINATIN GLOVES WITH ALOE VERA,NATURAL WATER SOLUBLE VITAMIN E AND VITAMIN C 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 Oct. 20, 2004

The assigned 510(K) number is K 042645

1.0 Submitter:

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

2.0 Regulatory Affairs Contact:

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

3.0 Name of device:

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

4.0 Identification of The Legally Marketed Device:

Class I patient examination gloves, 80LYY, non-sterile, powder free with Aloe Vera, natural water soluble Vitamin E and C, 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 with Aloe Vera, water soluble natural Vitamin E and C and protein labeling claim (50 microgram or less) is a disposable device made of natural rubber latex that may bear a trace amount 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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04-2645

7.0 Summary of the Technological Characteristics of the Device:

The Powder Free Latex Examination Gloves with Aloe Vera, natural water soluble Vitamin E and C 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 6124-01	<2 mg/glove
Protein Level	ASTM D5712-99	<50 microgram/gram
Biocompatibility	Primary Skin Irritation In RabbitsDermal Sensitization	PassesPasses

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 Aloe Vera, natural water soluble Vitamin E and C and with a protein labeling claim (50 microgram or less) meets ASTM standards, meet FDA pinhole requirements , biocompatibility requirements, and labeling claims. Consequently, this device is substantially equivalent to currently marketed devices.

Page 2 of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 2004

Qingdao Bestex Rubber & Plastic Products Company Limited C/O Mr. Zechuan Shao Bestex Protection Supply, Incorporated 2576 Lafayette Street Santa Clara, California 95050

Re: K042645

Trade/Device Name: Powder-Free Latex Examination Glove with Aloe Vera, Natural Water Soluble Vitamin E and C, and Protein Content Labeling (50 Microgram or Less) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: October 20, 2004 Received: November 9, 2004

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 vour 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.

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Page 2 - Mr. Shao

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. 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chris

Chiu Lin, Ph.D. 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

3.0 Indications for Use Statement:

INDICATIONS FOR USE

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

Indications For Use:

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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109 OR

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

Reuts

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device

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.