The Powder Free Nitrile Examination Glove (blue) with natural water soluble Vitamin E and Aloe Vera, Peppermint scented is a disposable device intended for medical purpose that is worn on the examiner's hand or finger(s)to prevent contamination between patient and examiner.

Device Description

Class I powder free nitrile examination gloves (blue) with natural water soluble Vitamin E and Aloe vera, peppermint scented, 80LZA, non-sterile meets all the requirements of ASTM standard D6319-00ae3 and FDA 21 CFR 800.20.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Nitrile Examination Gloves (Blue) with Natural Water Soluble Vitamin E and Aloe Vera, Peppermint Scented."

It's important to note that this device is a Class I medical device (patient examination glove), which typically undergoes different and less stringent testing than more complex AI-powered diagnostic devices. Therefore, many of the requested categories (like MRMC studies, expert consensus on ground truth, or sample sizes for test/training sets in the context of an AI algorithm) are not applicable here.

Acceptance Criteria and Device Performance

Characteristics	Standards	Device Performance
Dimensions	ASTM D 6319-00ae3	Meets
Physical Properties	ASTM D 6319-00ae3	Meets
Freedom from Pinholes	ASTM D 6319-00ae3, FDA 21 CFR 800.20	Meets
Powder Residue	ASTM D 6124-01	Meets, <2 mg/glove
Biocompatibility:	Primary Skin Irritation In Rabbits	Passes
- Skin Irritation	Dermal Sensitization	Passes
- Sensitization

Study Details

Sample size used for the test set and the data provenance:
- The document states that testing for physical specifications and dimensions was "conducted on gloves, Inspection level S-2, AQL 4.0, Pinholes at AQL 1.5." This refers to sampling plans defined in standards like ASTM D6319-00ae3 which specifies acceptable quality limits (AQL) and inspection levels (e.g., S-2 for reduced inspection). The exact number of samples tested for each criteria is not explicitly stated in the summary, but these AQL and inspection levels dictate the sample size.
- Data Provenance: Not explicitly stated, but assumed to be from the manufacturer's internal testing. Likely retrospective data from manufacturing lots. No country of origin for the data is specified other than the manufacturer being in China.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a glove, and ground truth for its performance properties (dimensions, physical properties, pinholes, powder residue) is established through standardized laboratory testing methods, not expert human assessment. Biocompatibility tests on rabbits are also standard laboratory procedures rather than expert consensus on human data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Performance is measured against objective standards, not through human adjudication of subjective assessments.
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:
- Not applicable. This is a physical medical device (glove), not an AI-powered diagnostic or assistive technology.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Dimensions, Physical Properties, Freedom from Pinholes, Powder Residue: Ground truth is defined by the objective, measurable parameters and thresholds specified in the referenced ASTM standards (e.g., specific tensile strength, elongation, maximum acceptable force at break, number of pinholes per batch, maximum powder residue) and FDA regulations.
- For Biocompatibility: Ground truth is established by the results of standardized animal tests (Primary Skin Irritation in Rabbits, Dermal Sensitization) compared against established pass/fail criteria for these tests.
The sample size for the training set:
- Not applicable. This is a physical medical device and does not involve AI/machine learning training sets.
How the ground truth for the training set was established:
- Not applicable. This is a physical medical device.

Summary

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AUG 1 5 2003

510(K) SUMMARY

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

POWDER FREE NITRILE EXAMINATIN GLOVES (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, and prepared on April 3,2003

The assigned 510(K) number is K031157

1.0 Submitter:

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

2.0 Regulatory Affairs Contact:

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

3.0 Name of device:

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

4.0 Identification of The Legally Marketed Device:

Class I nitrile patient examination gloves, 80LZA, non-sterile, powder free with natural water soluble Vitamin E and Aloe Vera, Peppermint Scented, that meets all the requirements of ASTM standard D 6319-00ae3 and FDA 21 CFR 800.20.

5.0 Device Description:

6.0 Intended Use of The Device:

The powder free nitrile examination glove (blue) with natural water soluble Vitamin E and Aloe vera, peppermint scented, is a disposable device 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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K031157

7.0 Summary of the Technological Characteristics of the Device:

The Powder Free Nitrile Examination Gloves (blue) with natural water soluble Vitamin E and Aloe Vera, Peppermint Scented, are summarized with the following technological characteristics compared to ASTM or equivalent standards:

Characteristics	Standards	Device Performance
Dimensions	ASTM D 6319-00ae3	Meets
Physical Properties	ASTM D 6319-00ae3	Meets
Freedom fromPinholes	ASTM D 6319-00ae3FDA 21 CFR 800.20	Meets
Powder Residue	ASTM D 6124-01	Meets, <2 mg/glove
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 6319-00ae3 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 Nitrile Examination Glove with water soluble natural Vitamin E and Aloe Vera, Peppermint Scented (blue) 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 seal for the Department of Health & Human Services (HHS). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.

AUG 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031157

Trade/Device Name: Powder-Free Nitrile Examination Glove (Blue) With Natural Water Soluble Vitamin E and Alove Vera, Peppermint Scented Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 2, 2003 Received: August 4, 2003

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.

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Page 2 - Mr. Zechuan 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 (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), please contact the Office of Compliance at (301) 594-4618. 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,

Patricia Cuencoffor

Susan Runner, DDS, MA Interim 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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K031157

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: Qingdao Bestex Rubber & Plastic Products Co., Ltd. 510(k) Number(if known): Device Name: Powder-free nitrile examination glove (blue) with natural water soluble Vitamin E and Alove Vera, Peppermint scented

Indications For Use:

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

Prescription Use Per 21 CFR 801.109 OR

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

Qlin S. Lin

Division Sian-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K031157
3

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.