The powder free vinyl patient examination glove (non-sterile) is a disposable device intended for medical purposes that is worn on the examiner's hand or fonger to prevent contamination between patient and examiner. It is sold as non sterile.

Device Description

Powder Free Vinyl Patient Examination Gloves (Non-Sterile), that meets all of the requirement of ASTM standard D 5250-06e1, except for sterility requirements.

AI/ML Overview

This document is a 510(k) Pre-market Notification Summary for Powder-Free Vinyl Patient Examination Gloves (Non-Sterile). It details the device, its intended use, and substantial equivalence to a predicate device.

Here's the information extracted and organized to address your request:

Acceptance Criteria and Device Performance Study

The testing described in the document is for a medical glove, which is a physical device, not an AI/software medical device. Therefore, many of the typical acceptance criteria and study descriptions for AI/software (e.g., human-in-the-loop, MRMC studies, ground truth establishment with experts, training/test set sizes for algorithms) do not apply.

The device's performance is gauged against established ASTM (American Society for Testing and Materials) standards for patient examination gloves. The "acceptance criteria" are these ASTM standards and the "study" is the nonclinical testing performed to show conformity.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristics	Acceptance Criteria (Standard)	Reported Device Performance
Dimension	Meets ASTM D 5250-06e1	Meets ASTM D 5250-06e1
Physical Properties	Meets ASTM D 5250-06e1	Meets ASTM D 5250-06e1
Freedom from pinholes	Meets ASTM D5151-06 (Water Leak Test)	Meets ASTM D5151-06 / 21 CFR 800.20
Powder Residual	Meets ASTM D5250-06e1 and D6124-01	Meets ASTM D5250-06e1 and D6124-01
Biocompatibility	Passes (Implied standard for safety)
Primary Dermal Irritation	N/A (Standard test for safety)	Passes (in rabbits)
Dermal Sensitization	N/A (Standard test for safety)	Passes (in guinea pig)

Note: The predicate device performance is also stated as meeting these same standards, indicating substantial equivalence.

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

The document does not explicitly state the sample sizes (e.g., number of gloves tested) for each specific test (e.g., pinholes, tensile strength) conducted for this particular 510(k) submission. These would be defined by the relevant ASTM standards.

Data Provenance: The testing was conducted by the manufacturer, Lifestyle Safety Products (Hui Zhou) Co., Ltd, in Hui Zhou City, Guang Dong Province, China. The testing is non-clinical performance evaluation, not patient-derived data, so "retrospective or prospective" doesn't directly apply in the usual clinical
AI sense.

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

This is not applicable as the device is a physical glove, not an AI/software device requiring "ground truth" established by human experts in the medical imaging/diagnostic sense. The "ground truth" here is objective measurement against engineering and material science standards (ASTM).

4. Adjudication Method for the Test Set

Not applicable for a physical device being tested against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. This is a non-AI/software device. MRMC studies are specific to evaluating human reader performance with and without AI assistance for tasks like diagnosis or image interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective engineering and material science measurements against:

ASTM (American Society for Testing and Materials) standards (e.g., D5250-06e1 for dimensions and physical properties, D5151-06 for freedom from pinholes, D6124-01 for powder residual).
Biocompatibility tests on animal models (rabbits and guinea pigs) as per standard safety protocols.
FDA regulations (e.g., 21 CFR 800.20 for pinholes).

8. The Sample Size for the Training Set

Not applicable. This is a manufactured product, not an AI model requiring a training set. The manufacturing process is controlled by Good Manufacturing Practices (GMP).

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

Not applicable. No training set as it's not an AI model.

Summary

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SEP 13 2012

510 (K) Summary (21 CFR 807.92)

510(K) Summary

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

(applicant leave blank) The assigned 510(K) number is:

Premarket Notification [510(K)] Summary

[(a)(1)] The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared:

Submitter's name: Submitter's address:

Phone Number: Fax Number: Name of contact person: Date the summary was prepared: Lifestyle Safety Products (Hui Zhou) Co., Ltd Daxiaotang Village, Luoyang Town, Boluo County Hui Zhou City, Guang Dong Province, 516120 China 0086-0752-6865040 0086-0752-6863392 Ms. Yew Sing Mei January 26, 2011

[(a)(2)] The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known

Device/ Proprietary Name: (Non-Sterile) Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product code:

Patient examination glove Patient examination glove 21 CFR 880.6250

Powder Free Vinyl Patient Examination Gloves,

General Hospital LYZ

[{a){3}} An identification of the legally marketed device to which your firm is claiming substantial equivalence.

Predicate Device Information:

(1) K100978, "Powder-Free Non-Sterile Vinyl Examination Glove", manufactured by "Jiangsu Sunshine Plastic Products, Co., Ltd"

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[(a){4)| A description of the device

Device Description: Powder Free Vinyl Patient Examination Gloves (Non-Sterile), that meets all of the requirement of ASTM standard D 5250-06e1, except for sterility requirements.

[{a)(5)] The summary describes the intended use of the device

Device Intended Use: Powder Free Vinyl Patient Examination Gloves (Non-Sterile) 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. It is sold as non sterile.

Comparison to Predicate Devices

The Powder free Vinyl patient examination gloves (Non-Sterile) are compared with the following Predicate Devices in terms of intended use, design, material, specification, and performance.

(1) K100978, "Powder-Free Non-Sterile Vinyl Examination Glove", manufactured by "Jiangsu Sunshine Plastic Products, Co., Ltd"

(2)

The following table shows similarities and differences of use, design, and material between our device and the predicate devices.

Description	Our Device	Predicate Device (K100978)
Indication for Use	Disposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner	Same
Basic Design Material	Poly Vinyl Chloride	Same
Size	S, M, L, XL	Same
Single Use	Yes	Yes
Sterile	Non sterile	Non sterile

Table 5.1 Comparison of Intended Use, Design, and Material

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[(a)(6)] A summary of the technological characteristics of new device compared to the predicate device

The Powder Free Vinyl Patient Examination Gloves (Non-Sterile) are summarized with the following technological · characteristics compared to ASTM or equivalent standard.

Characteristics	Our device	Predicate Device Performance
Dimension	Meets ASTM D 5250-06e1	Meets ASTM D 5250-06e1
Physical Properties	Meets ASTM D 5250-06e1	Meets ASTM D 5250-06e1
Freedom from pinholes	Meets ASTM D5151-06	Meets 21 CFR 800.20
Powder Residual	Meets ASTM D5250-06e1 and D6124-01	Meets ASTM D6124-01
Biocompatibility	Primary Dermal Irritation in rabbits	Passes
	Dermal Sensitization in the guinea pig	Passes

[{b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence.

Powder Free Vinyl Patient Examination Gloves (Non-Sterile), meet the requirements per ASTM D5250-06e1, per ASTM D6124-01, and ASTM 5151-06. It is safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended uses.

[(b)(2)] A brief discussion of the clinical submitted, reference, or replied on in the premarket notification submission for a determination of substantial equivalence.

Clinical data is not needed for gloves or for most devices cleared by the 510(K) process.

[(b)(3)] The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than legally marketed device identified in (a)(3). 1

Based on the comparison of intended use, design, materials, and performance, it can be concluded that our vinyl disposable examination gloves powder free non-sterile, meets the ASTM standard or equivalent standard and FDA requirements for water leak test on pinhole AQL, meet labeling claims and are substantial equivalent to its predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Lifestyle Safety Products (Hui Zhou) Company, Limited C/O Registrar Corporation Ms. Rhonda T. Alexander Senior Regulatory Specialist Medical Device & Drug Division 144 Research Drive Hampton, Virginia 23666

SEP 13 2012

Re: K112741

Trade/Device Name: Powder-Free Vinyl Patient Examination Gloves (Non-Sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: September 4, 2012 Received: September 5, 2012

Dear Ms. Alexander:

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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Page 2- Ms. Alexander

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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.

Sincerely yours,

For

Anthony D. Watson, B.S., M.S., M.B.A. 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: Lifestyle Safety Products (Hui Zhou) Co., Ltd

510(k) Number (if known): ___N/A (112441

Device Name: Powder Free Vinyl Patient Examination Gloves (Non-Sterile)

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

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Rohit Gangulin 9/12/12

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Anesthesiology, General Hospital Infection Control, Dental

510(k) Number:

11.2+41

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.