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 I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Weilin Plastic and Rubber Products Co., Ltd. Vinyl Examination Powder Free Gloves, Clear (K123590), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This device is a patient examination glove and its acceptance criteria are based on meeting ASTM Standard D5250-06 and specific FDA requirements for glove integrity and biocompatibility, along with demonstrating substantial equivalence to a predicate device (K992821).

Acceptance Criteria (from ASTM D5250-06 & FDA)	Reported Device Performance (Weilin Plastic and Rubber Products Co., Ltd.)
Physical and Dimensions Testing:
Inspection Level S-2, AQL 2.5	Meets requirements (implicitly for all physical/dimensional attributes)
Before Aging:
Tensile Strength (Mpa)	16.9 Mpa (Average)
Ultimate Elongations	550% (Average)
After Aging:
Tensile Strength (Mpa)	14.4 Mpa (Average)
Ultimate Elongations	500% (Average)
Dimensions (Medium Size):
Overall Length	Average over 230mm
Width of Palm	Average 95mm
Palm Thickness	Average 0.073 mm
Figure Thickness	Average 0.090 mm
Residual Powder (ASTM D6124-06):
< 2 mg per glove	< 2 mg per glove, no defect gloves found
Pinhole Results (ASTM D5151-06 & FDA 1000ml Water Fill Test):
FDA 1000 ml Water Fill Test requirements (AQL 2.5, Inspection Level I)	Meets requirements
Pinhole AQL 2.5 (from ASTM D5151-06)	Less than two pinholes out of 125 gloves. AQL 2.5 is met.
Biocompatibility (ISO 10993-10):
Primary Skin Irritation	Passes
Dermal Sensitization	Passes

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

Pinhole Testing: 125 gloves were tested for pinhole results (ASTM D5151-06).
FDA 1000 ml Water Fill Test: Sample sizes were based on AQL 2.5, Inspection Level I, though the exact number is not explicitly stated.
Physical and Dimensions Testing: Sample sizes for these tests were based on Inspection Level S-2, AQL 2.5, though the exact number is not explicitly stated.
Residual Powder: Sample sizes were not explicitly stated but guided by ASTM D6124-06.
Biocompatibility: Sample sizes for ISO 10993-10 (Primary Skin Irritation and Dermal Sensitization) were not explicitly stated.
Data Provenance: The document does not explicitly state the country of origin for the data, but the submitter is based in Qingzhou, Shandong, China, suggesting the testing was likely conducted there or overseen by the company. The studies are assumed to be retrospective as they are described as "tests performed" to demonstrate compliance.

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

This type of device (patient examination gloves) does not typically involve "experts" establishing a "ground truth" in the way a diagnostic imaging AI would. The "ground truth" for these tests comes from objective measurements against established international and FDA standards (ASTM, ISO). Therefore, this section is not applicable in the context of this device.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective measurements against defined standards, not subjective assessments requiring expert adjudication.

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 physical glove, not an AI-powered diagnostic tool, so MRMC studies are not relevant.

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

Not applicable. This device is a physical glove, not an algorithm, so standalone AI performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance relies on objective physical, chemical, and biological measurements compared against:

Established international consensus standards (ASTM D5250-06, ASTM D6124-06, ASTM D5151-06, ISO 10993-10).
Regulatory requirements (e.g., FDA 1000 ml Water Fill Test).

8. The sample size for the training set

Not applicable. There is no training set for a physical device like a glove. The product is manufactured and tested according to quality control specifications.

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

Not applicable. There is no training set for this device.

Summary

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K123590

510 (K) SUMMARY

JUN 1 7 2013

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

Submitter's Identification: 1.

Weilin Plastic and Rubber Products Co., Ltd. 601 Jiangjunsan Road Qingzhou, Shandong, China

Date summary prepared: Nov 03, 2012

2. Name of the Device:

Weilin Plastic and Rubber Products Co., Ltd. . Vinyl Examination Powder Free Gloves; Clear; Size Large

· 3. Predicate Device Information:

Shiiiazhuang 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 I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.

5. Intended Use:

6. Comparison to Predicate Devices:

Weilin Plastic and Rubber Products Co., Ltd. Vinyl Examination Powder Free Gloves, clear, are substantially equivalent in safety and effectiveness to the Shijiazhuang Hongxiang Plastic Products Co., Ltd.(K992821). See Table 7-2.

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

The standards used for Weilin Plastic and Rubber Products Co., Ltd. glove production are based on ASTM-D-5250-06. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 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).

8. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic claim.

9. Conclusions:

Weilin Plastic and Rubber Products Co., Ltd. Vinyl Examination Powder Free Gloves, clear, conform fully to ASTM-D-5250-06 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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	Proposed Device	Predicate Device (K992821)
Description	Weilin Plastic and Rubber Products Co., LtdPowder-Free Vinyl Patient ExaminationGloves, Clear	Shijiazhuang Hongxiang Powder-freeVinyl Patient Examination Gloves
Labeling: Instructionfor use	A garment covering the hand and waist area.Clovers have separate sheaths or openings foreach finger and the thumb.	Substantially equivalent
Labeling: Labels onthe carton	Labels include: Product name; color; "singleuse Only" size, piece count, lot number,distributor name, and manufacturer address.	Substantially equivalent
Device Materials	Poly Vinyl ChloridePolyurethaneDiisononyl Phthalate (DINP)	Substantially equivalent
Before Aging: TensileStrength(Mpa) andUltimate Elongations	Average Tensile Strength (Mpa): 16.9Average Ultimate Elongations: 550%	Substantially equivalent
After Aging: TensileStrength(Mpa) andUltimate Elongations	Average Tensile Strength (Mpa): 14.4Average Ultimate Elongations: 500%	Substantially equivalent
Overall Length onMedium Size	Average over 230mm	Substantially equivalent
Width of Palm onMedium Size	Average 95mm	Substantially equivalent
Palm Thickness	Average 0.073 mm	Substantially equivalent
Figure Thickness	Average 0.090 mm	Substantially equivalent
Residual Powder	According to ASTM D6124-06 Standard TestMethod for Residual Powder on Medical glovesfor the determination of residual powdercontent. Testing result indicates the weight ofall types of residual or powder on finishedpowder-free gloves as < 2 mg per glove andthere is no defect glove found according toASTM D6124-06.	Substantially equivalent
Pinhole Results	According to ASTM D5151-06, Testing resultindicates pinhole were found less than twopieces gloves out of 125 pieces gloves. AQL2.5 is met.	Substantially equivalent
BiocompatibilityResult: Primary SkinIrritation	ISO 10993-10 passes	Substantially equivalent
Dermal Sensitization	ISO 10993-10 passes	Substantially equivalent
Summary ofcomparison	Weilin Plastic and Rubber Products Co., Ltd. powder-free Vinyl examination gloves,clear color (subject device) and Shijiazhuang Hongxiang, powder-free Vinylexamination glove (predicate device) are substantially equivalent in all technologicalcharacteristics, including tensile strength, ultimate elongations size, thickness, residualpowder and pinhole.

Table 7-2. Side by-Side Comparison of Intended Use, Design, Material, Blocompatibility, and Performance Testing

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

June 17, 2013

Weilin Plastic and Rubber Products Company, Limited C/O Mr. Ling Zhu Basic Medical Industries, Incorporated 12390 East End Avenue CHINO CA 91710

Re: K123590

Trade/Device Name: Vinyl Examination Powder Free Gloves, Clear Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: March 22, 2013 Received: May 16, 2013

Dear Mr. Zhu:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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-Sincerely-yours,-

Tejas
Clinic
DAGI

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRIO

FOR

Kwame Ulmer M.S Acting Division Director Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows a black and white drawing of a hand with fingers spread apart. The hand is positioned inside of a square frame. The hand appears to be reaching out or waving. The image is simple and lacks any background details.

Weilin Plastic and Rubber Products Co., Ltd.

601 Jiangjunsan Road Qingzhou, Shandong, China

INDICATIONS FOR USE

Applicant: Weilin Plastic and Rubber Products Co., Ltd.

510(k) Number:

Vinyl Examination Powder Free Gloves, Clear 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 _________________________________________________________________________________________________________________________________________________________ X

Factory Initials

Elaine S. Mayha

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

510(k) Number; K123590

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.