POWDERED VINYL EXAMINATION GLOVES by SHU TONG XINGHUA CO., LTD.

A Powdered Viny! Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

Powdered Vinyl Examination Gloves

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powdered Vinyl Examination Glove":

Important Note: The provided document is a 510(k) clearance letter from the FDA for a medical device (Powdered Vinyl Examination Glove). It is NOT a detailed study report. Therefore, much of the information typically found in a study report, such as specific sample sizes for training/test sets, details about ground truth establishment, or expert qualifications, will not be present in this type of document. This letter primarily confirms that the device is "substantially equivalent" to predicate devices, meaning it meets existing standards and specifications.

Based on the nature of this document and the product (examination gloves), the acceptance criteria are generally based on physical performance standards rather than diagnostic performance metrics for an AI/algorithm-driven device.

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is an examination glove, the "performance" is related to its physical properties and barrier integrity, not diagnostic accuracy. The FDA clearance implies that the device meets the applicable standards, which would include criteria like those in ASTM D5250 for vinyl examination gloves.

Acceptance Criteria Category	Specific Acceptance Criteria (Example from relevant ASTM standards)	Reported Device Performance (Implied by 510(k) Clearance)
Physical Dimensions	Varies by size (e.g., length, palm width, thickness) within specified tolerances.	Meets dimensional specifications for examination gloves.
Freedom from Holes (AQL)	Acceptable Quality Level (AQL) for pinholes (e.g., 2.5% for critical defects).	Device demonstrated an AQL for pinholes that met the standard.
Tensile Strength	Minimum tensile strength (e.g., before and after accelerated aging).	Meets minimum tensile strength requirements.
Elongation at Break	Minimum elongation at break (e.g., before and after accelerated aging).	Meets minimum elongation at break requirements.
Protein Content	(Less relevant for vinyl, but a criterion for latex gloves).	Not applicable for vinyl gloves.
Biocompatibility	Absence of skin irritation, sensitization (ISO 10993 series).	Demonstrated biocompatibility suitable for skin contact.
Sterility	(If claimed sterile, but examination gloves are often non-sterile).	(If non-sterile: Meets non-sterile requirements).

Note: The 510(k) letter itself does not explicitly list these criteria or detailed results. It states that the device is "substantially equivalent" to predicate devices, which means it has been demonstrated to perform as safely and effectively as legally marketed devices under similar specifications and standards. The underlying testing would have been conducted by the manufacturer to demonstrate compliance with these standards.

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

Sample Size: Not specified in the 510(k) letter. For physical testing of gloves, sample sizes are dictated by relevant ASTM/ISO standards (e.g., ANSI/ASQ Z1.4 for AQL sampling). This would typically involve taking samples from production lots (e.g., 200 gloves per lot for a specific AQL level) over a period to demonstrate consistency.
Data Provenance: The manufacturer, Shu Tong Xinghua Company, Limited (China), would have conducted the tests. The data would be prospective in the sense that the testing is performed on manufactured lots of the device.

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

This question is not applicable in the context of an examination glove's functional performance where "ground truth" refers to diagnostic accuracy. The "ground truth" for glove testing is derived from standardized laboratory measurements (e.g., water leak tests for pinholes, mechanical testers for tensile strength).
The "experts" involved would be qualified laboratory technicians and quality control personnel, trained in performing the specific ASTM/ISO tests. Their qualifications would involve training in laboratory procedures, quality assurance, and potentially relevant engineering or scientific degrees.

4. Adjudication Method for the Test Set:

Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., medical image reading) where disagreement among experts might occur. Glove testing involves objective physical measurements that have established 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 physical product (examination glove), not an AI-driven diagnostic or interpretative system. Therefore, no MRMC study, AI assistance, or human reader improvement metrics are relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

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

7. The Type of Ground Truth Used:

The "ground truth" for examination gloves is based on objective physical and chemical measurements against established national and international standards (e.g., ASTM D5250, D6319 for synthetic gloves, ISO 10993 for biocompatibility). Examples include:
- Direct measurement: Glove dimensions (length, width, thickness).
- Water leak test: For detection of pinholes.
- Mechanical testing: Tensile strength and elongation at break.
- Chemical analysis: For material composition and potential leachables.
- Biocompatibility testing: In-vitro and/or in-vivo tests for irritation and sensitization.

8. The Sample Size for the Training Set:

Not applicable in the AI sense. For manufactured goods, the "training set" could be loosely analogous to the data collected during product development and early manufacturing runs to refine the production process and ensure consistency. However, sample sizes for such internal validation are not typically disclosed in 510(k) clearances and are part of the manufacturer's internal quality system documentation.

9. How the Ground Truth for the Training Set Was Established:

Not applicable in the AI sense. Ground truth for manufacturing processes is established through adherence to engineering specifications, material standards, and quality control procedures. Any "training" of a manufacturing process would involve iterative testing and refinement based on the measurable outcomes of the physical tests mentioned in point 7.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is composed of three curved lines, giving it a modern and abstract appearance. The text is in a simple, sans-serif font, and the overall design is clean and professional.

Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MI) 20993-00002

April 11, 2014

Shu Tong Xinghua Company, Limited Mr. Su Song Shi General Manager West of Xi Huan Road Economic Development District Xinghua City, Jiangsu 225700 CHINA

Re: K122176

Trade/Device Name: Powdered Vinyl Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: March 17, 2014 Received: April 1, 2014

Dear Mr. Shi:

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 mislcading.

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.

{1}------------------------------------------------

Page 2 - Mr. Shi

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 (reporting of medical device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Image /page/1/Picture/7 description: The image contains a combination of text and graphic elements. The text includes "Tejashri Purohit-Sheth, M.D.," "Clinical Deputy Director," and "DAGRID." There is also a signature present. The letters FDA are in a triangle shape.

Sincerely yours,

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K122176

Device Name

Powdered Vinyl Examination Gloves

Indications for Use (Describe)

A Powdered Viny! Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

.. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CONTRACTOR CONTRACT CONTRACT FOR FOR FOR FOR FOR FOR FOR FOR CONSTITUTION CONTROLLERS CONTRACTOR Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/2/Picture/14 description: The image shows the name "Elizabeth F. Claverie -S" in bold font. Below the name is the date and time "2014.04.11 12:56:57 -04'00'" also in bold font. The date and time are likely a timestamp.

FORM FDA 3881 (1/14)

Page 1. of 2

001 } 40-674

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.