A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)

Device Description

Class I powder free colored(green) latex examination gloves with aloe vera and protein labeling claim(50 microgram or less) ,80LYY, non-sterile meets all the requirements of ASTM standard D3578-00 and FDA 21 CFR 800.20.

AI/ML Overview

This is an examination glove, not an AI/ML device. Hence, the requested information about AI/ML device studies and ground truth is not applicable.

However, I can provide the acceptance criteria and performance of the glove:

Acceptance Criteria and Device Performance

Characteristic	Acceptance Criteria (Standards)	Reported Device Performance
Dimensions	ASTM D 3578-00	Meets
Physical Properties	ASTM D 3578-00	Meets
Freedom from Pinholes	ASTM D 3578-00; FDA 21 CFR 800.20	Meets (AQL 1.5)
Powder Free	ASTM D 6124-97	<2 mg/glove
Protein Level	ASTM D5712-95	<50 microgram/gram
Biocompatibility	Primary Skin Irritation In Rabbits	Passes (not a primary skin irritant)
	Dermal Sensitization	Passes (Not a contact sensitizer)

Study Information (Not Applicable for AI/ML Device)

Since this is not an AI/ML device, the following points are not applicable:

Sample size used for the test set and the data provenance: Not applicable. Performance testing was done on batches of gloves according to ASTM and FDA standards (e.g., Inspection level S-2, AQL 4.0 for dimensions and physical properties, AQL 1.5 for pinholes).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for glove performance is defined by established industry and regulatory standards.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Ground truth is based on physical and chemical testing against established standards (ASTM and FDA regulations).
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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OCT = 1 2001

510(K) SUMMARY

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

COLORED(Green)POWDER FREE LATEX EXAMINATIN GLOVES WITH ALOE VERA 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 July 25, 2001

The assigned 510(K) number is KO12709

1.0 Submitter:

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

2.0 Regulatory Affairs Contact:

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

3.0 Name of device:

Trade Name: Undetermined Examination Glove Common Name: 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, that meets all the requirements of ASTM standard 3578-00 and FDA 21 CFR 800.20.

5.0 Device Description:

6.0 Intended Use of The Device:

The powder free colored latex examination glove with aloe vera 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.

7.0 Summary of the Technological Characteristics of the Device:

The Powder Free Colored Latex Examination Gloves with Aloe Vera and with Protein Content Labeling(50 micrograms or less) are summarized with the following technological characteristics compared to ASTM or equivalent standards:

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Characteristics	Standards	Device Performance
Dimensions	ASTM D 3578-00	Meets
Physical Properties	ASTM D 3578-00	Meets
Freedom from	ASTM D 3578-00	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
Biocompatability	Primary Skin Irritation In Rabbits	Passes(not a primary skin irritant)
	Dermal Sensitization	Passes(Not a contact sensitizer)

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 3578-00 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 showing no primary sin irritation or sensitization reactions, 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 Colored Latex Examination Glove with Aloe Vera 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.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring a staff with a serpent entwined around it, representing health and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT = 1 2001

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

Re: K012709

Trade/Device Name: Powder Free Latex Examination Gloves with Aloe Vera and Protein Content Labeling Claim (50 Micrograms or Less) (Green) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: July 25, 2001 Received: August 14, 2001

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

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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 (QS) 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Clalatrist

Tim A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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INDICATION FOR USE

Applicant: Qingdao Bestex Rubber & Plastic Co. , Ltd.

510(k) Number (if known): KO 12709

Device Name: Powder-Free Latex Examination Glove Colored, with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less) ( GREEN )

Indications For Use:

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qlin S. him

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number

Prescription Use Per 21 CFR 801.109 OR

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

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.