A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Device Description

Class I powder-free patient examination glove LYZ, meets all of the requirements of ASTM Standard D5250-00E1. Class I powdered patient examination glove, LYZ, also meets all the requirements of ASTM Standard D5250-00E1. as well as all the requirements of ASTM Standard D6124-01 for powdered glove and its residue powder.

AI/ML Overview

The provided text describes a 510(k) summary for disposable PVC examination gloves. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a clinical study with performance metrics. Therefore, most of the requested information (acceptance criteria, study details, sample sizes, expert ground truth, MRMC study, standalone performance, training set) is not applicable or cannot be extracted from this document, as it pertains to a different type of regulatory submission or product evaluation.

Here's an analysis based on the provided text, highlighting what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is substantial equivalence to predicate devices. This means the device must be as safe and effective as legally marketed devices. Another criterion mentioned is adherence to ASTM Standard D5250-00E1 (for both powdered and powder-free gloves) and ASTM Standard D6124-01 (for powdered gloves and residue powder). It also mentions meeting "pinhole FDA requirements," "biocompatibility requirements," and "labeling claim requirements."
Reported Device Performance: The document states that the device "meets all of the requirements" of the specified ASTM standards and "meets pinhole FDA requirements, biocompatibility requirements and labeling claim requirements." It confirms substantial equivalence based on "Non-clinical tests."

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Devices	Established based on Non-clinical tests; declared substantially equivalent.
ASTM Standard D5250-00E1 (for all gloves)	Meets all requirements.
ASTM Standard D6124-01 (for powdered gloves)	Meets all requirements.
Pinhole FDA Requirements	Meets requirements.
Biocompatibility Requirements	Meets requirements.
Labeling Claim Requirements	Meets requirements.

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

Not Applicable/Not Provided. The document refers to "Non-clinical tests" but does not specify sample sizes or data provenance (country of origin, retrospective/prospective). This is common for device submissions like examination gloves where performance is typically assessed through standardized laboratory tests and material properties rather than clinical test sets with human subjects.

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

Not Applicable/Not Provided. Ground truth established by experts is typically relevant for diagnostic devices or AI algorithms. For examination gloves, performance is assessed against physical and chemical standards.

4. Adjudication method for the test set:

Not Applicable/Not Provided. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among experts in ground truth establishment for diagnostic or subjective assessments, which isn't the case for examination gloves.

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 is a medical device (examination glove), not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.

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

Not Applicable. This is not an AI algorithm.

7. The type of ground truth used:

Standard Specifications and Laboratory Test Results: The "ground truth" here is the adherence to established industry standards (ASTM D5250-00E1, ASTM D6124-01) and specific FDA requirements for glove performance (e.g., pinhole, biocompatibility). Performance is measured through non-clinical laboratory tests.

8. The sample size for the training set:

Not Applicable. This is not a machine learning or AI device that requires a training set.

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

Not Applicable. As above, no training set is involved.

Summary of what can be extracted:

The 510(k) summary indicates that the device's acceptance criteria are based on substantial equivalence to existing predicate devices and compliance with specific ASTM standards and FDA requirements (pinhole, biocompatibility, labeling). The "study" that proves this involves non-clinical laboratory tests that demonstrate the device meets these standards and requirements. No human subject studies, expert consensus, or AI performance evaluations are detailed in this type of submission.

Summary

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510(k) Summary

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

The assigned 510(k) number is: K053259

し Submitter:
George Su Crosslinks International 1800 Century Park East, Suite 600 Los Angeles, CA 90067 USA Tel: 310-229-5748 Fax: 310-388-1067 Email: Crosslinks2000@aol.com

Date of Summary: Jan 5, 2006

1. Name of Device Disposable PVC Examination Glove, Powdered and Powder-free
Predicate Device Information 3.
- (1) Powder-free Vinyl Examination Gloves Bernard Technologies, Inc. K-number: K033229
- (2) Pre-Powdered Non-Sterile Vinyl Examination Glove Shangdong Perfect Plastic Co., Ltd K-number: K042213
1. Device Description:

1. Intended Use
  A patient examination glove, either powder-free, is a disposable device intended for medical purposes that is worn on the hand of healthcare and other personnel to prevent contamination between healthcare personnel and the patient's body.

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6. Comparison to predicate device:

Practical Protective Plastic Manufactory, Ltd. Disposable PVC Examination Glove, Powdered, and Powder-free, are substantially equivalent in safety and effectiveness to the Pre-powdered Non-sterile Vinyl Examination Glove. from Shandong Perfect Plastic Co., Ltd., and the Powder-free Vinyl Examination Glove of Bernard Technologies, Inc. This conclusion was established based on the Non-clinical tests, and by being brought in conformance with the Standard of ASTM D 5252-00E1.

7. Conclusion:

Practical Protective Plastic Manufactory, Ltd. Disposable PVC Examination Gloves, Powdered, and Powder-free, are substantially equivalent in safety and effectiveness to the legally marketed gloves on the US market: Pre-powdered Non-sterile Vinyl Examination Glove from Shandong Perfect Plastic Co., Ltd., and the Powder-free Vinyl Examination Glove of Bernard Technologies, Inc. It also conforms to ASTM D5250-00E1 standards, as well as applicable 21 CFR references, and, meets pinhole FDA requirements, biocompatibility requirements and labeling claim requirements.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized representation of an eagle with three lines forming its wings and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the eagle in a circular pattern.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2006

Practical Protective Plastic Manufactory Limited C/O Ms. Laura Danielson Responsible Third Party Official TÜV America, Incorporated 1775 Old Highway 8 New Brighton, Minnesota 55112-1891

Re: K053259

Trade/Device Name: (Mutiple Brand Name) Disposable Vinyl Patient Examination Gloves, Powdered and Powder-Free Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: January 3, 2006 Received: January 9, 2006

Dear Ms. Danielson:

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 (Spccial 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 Ms. Danielson

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 (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Ques

Chiu Lin, Ph.D. 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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Indications for Use

Applicant Name:	Practical Protective Plastic manufactory, Ltd.
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Device Name: (Mutiple Brand Name) Disposable Viny) Patient Examination Gloves, Powdered and Powder-free

WW & WA BoV BASAAP	10111:.- CHINDAN	1tB & Course Collection Corporation Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Comp	. BALLA BERESHIP AND A B A LEGICARD CONNECT LAND LAND LAND LA LE CHARACT AN LE LE CHARACT COLLEGIAL COLLMARK A L L L C L C . L . L . L . L . L

Indications for Use:

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

anoral Houplia

Shuh H. Munguy to 1/2/06

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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.