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

Device Description

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-00.

AI/ML Overview

The provided text is a 510(k) summary for Zibo Wanci Plastic & Rubber Co., Ltd.'s Synthetic Vinyl Patient Examination Gloves - Powder Free. This document establishes the substantial equivalence of the device to a predicate device, rather than proving its effectiveness through a typical clinical study with acceptance criteria, human readers, or specific outcomes data regarding disease.

The "acceptance criteria" discussed in this document refer to adherence to established industry standards and regulatory requirements for medical gloves, and the "study" is a series of non-clinical tests performed to demonstrate compliance with these standards.

Here's an analysis of the provided information in the requested format:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard / Test)	Requirement	Reported Device Performance	Study Reference
Physical and Dimensions Testing:			ASTM-D-5250-00
- ASTM-D-5250-00	Meet all requirements	All testing meets requirements for Physical and Dimensions Testing.	Section 7
- Inspection Level S-2	AOL 2.5	Meets AOL 2.5	Section 7
Freedom from Holes (FDA Water Fill Test):			FDA 1000 ml. Water Fill Test
- FDA 1000 ml. Water Fill Test	AOL 2.5 (Inspection Level I)	Meets these requirements with samplings of AOL 2.5, Inspection Level I.	Section 7
Biocompatibility Testing:
- Primary Skin Irritation	No primary skin irritant reactions	Results showing no primary skin irritant reactions.	Section 7
- Skin Sensitization (allergic contact dermatitis)	No sensitization reactions	Results showing no sensitization reactions.	Section 7
Powder-Free Claim:	No more than 2 mg powder per glove	Conducted to insure that our gloves meet our "powder-free" claims.	Section 7

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

Sample Size for Physical and Dimensions Testing: The document mentions "Inspection Level S-2, AOL 2.5". This refers to an Acceptance Quality Limit (AQL) sampling plan described in ASTM standards. However, the specific number of gloves sampled for these tests is not explicitly stated.
Sample Size for FDA 1000 ml. Water Fill Test: The document mentions "samplings of AOL 2.5, Inspection Level I". The specific number of gloves sampled for this test is not explicitly stated.
Sample Size for Biocompatibility Testing: The specific number of subjects or samples used for primary skin irritation and skin sensitization testing is not explicitly stated.
Data Provenance: The tests were conducted by the manufacturer, Zibo Wanci Plastic & Rubber Co., Ltd., presumably in China. The data is retrospective for the purpose of this 510(k) submission, meaning the tests were performed prior to the submission to demonstrate compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. For medical gloves, "ground truth" is not established by expert consensus on diagnoses or interpretations. Instead, compliance with objective, measurable performance standards (e.g., tensile strength, dimensions, freedom from holes, biocompatibility) is the "ground truth." These standards are developed by organizations like ASTM and regulatory bodies like the FDA. The testing itself is typically performed by trained technicians in a laboratory setting according to the standard's methodology.

4. Adjudication method for the test set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, especially in image-based diagnostic studies. For objective physical and chemical properties of medical gloves, the results are determined by adherence to pre-defined numerical thresholds and test methodologies, not by expert consensus or adjudication. The "adjudication" is met when the test results fall within the specified AQLs (Acceptance Quality Limits) or pass/fail criteria.

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

Not Applicable. This device is a medical glove, a physical product, not an AI-powered diagnostic tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to its evaluation.

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

Not Applicable. As mentioned, this is a physical medical device (glove), not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for this device's performance is based on objective, measurable criteria defined by recognized consensus standards (e.g., ASTM-D-5250-00) and regulatory requirements (e.g., FDA Water Fill Test, biocompatibility guidelines). These standards specify acceptable ranges for physical properties (dimensions, tensile strength, elongation), maximum permissible defect rates (pinholes), and biological reactions (irritation, sensitization).

8. The sample size for the training set

Not Applicable. The concept of a "training set" applies to machine learning algorithms. This document describes the testing of a physical medical device, not the development of an AI model.

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

Not Applicable. As there is no training set for an AI model, this question is not relevant.

Summary

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KCS 3047

FEB 1 2 2009

510 (K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21CFR 807.92.

1. Submitter's Identification:

Geng, Xiao Cong Zibo Wanci Plastic & Rubber Co., Ltd. Hi-tech Industry Area, Cross of Jiging and Zhangtian freeway Zibo, Shandong, China Date summary prepared: October 9, 2008

2. Name of the Device:

Zibo Wanci Plastic & Rubber Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free

3. Predicate Device Informaton:

Shijiazhuang Hongxiang Plastic Products Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free (K992821)

4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-00.

ਨ Intended Use:

Comparison to Predicate Devices: 6.

Zibo Wanci Plastic & Rubber Co., Ltd. Synthetic Vinyl Patient Examination Gloves, Powder-Free are substantially equivalent in safety and effectiveness to the Shijiazhuang Hongxiang Plastic Products Co., Ltd. and Sunmax Enterprise Shanghai Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, Powderfree.

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.7. Discussion of Non-Clinical tests performed for Determination of Substantial Equivalence are as follows:

The standards used for Zibo Wanci Plastic & Rubber Co., Ltd. glove production are based on ASTM-D-5250-00. All testing meets requirements for Physical and Dimensions Testing conducted on gloves. Inspection Level S-2. AOL 2.5.

The FDA 1000 ml. Water Fill Test was also conducted with samplings of AOL 2.5, Inspection Level I, 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 is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).

Discussion of Clinical Tests Performed: 8.

Not Applicable -- There is no hypoallergenic claim.

9. Conclusions:

Zibo Wanci Plastic & Rubber Co., Ltd. Synthetic Vinyl Patient Examination Gloves, Powder-Free conform fully to ASTM-D-5250-00 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the top half of the circle. The bottom half of the circle contains a stylized image of a human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zibo Wanci Plastic & Rubber Company, Limited C/o Mr. John Zhao Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710

FEB 1 2 2009

K083047 Re:

Trade/Device Name: Patient Vinyl Examination Gloves, Powder Free, Non-Sterile Regulation Number: 21 CFR 880.6250 | | | | | Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: February 3, 2009 Received: February 4, 2009

Dear Mr. Zhao:

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. Zhao

Enclosure

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Anthony D. Nastair for
Civil Judicial MD

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Zibo Wanci Plastic & Rubber Co., Ltd.

Hi-tech Industry Area, Cross of Jiqing and Zhangtian freeway, Zibo, Shandong, China

INDICATIONS FOR USE

Zibo Wanci Plastic & Rubber Co., Ltd. Applicant:

510(k) Number:

Patient Vinyl Examination Gloves, Powderfree, Non-Sterile Device Name:

Indications of Use:

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

Prescription Use

Over the Counter Use

Factory Initials

GCJ (fa 48m)

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

510(k) Number: KO83047

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.