A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

AI/ML Overview

The provided text is a 510(k) summary for a medical device: "Better Care Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color." This document describes the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, many of the requested elements for an AI/ML study (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC study, standalone performance) are not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria and reported device performance from the non-clinical tests that were performed to demonstrate substantial equivalence to the predicate device.

Here's the information based on the provided document:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Test Name	Standard / Requirement	Reported Device Performance
Physical and Dimensions Testing	ASTM D-5250-06e1 (Inspection Level S-2, AQL 4.0)	All testing meets requirements for physical and dimensions testing.
Pinhole / Water Fill Test	FDA 1000 ml. Water Fill Test based on ASTM DS151-06 (Inspection Level G-1, AQL 2.5)	Meets these requirements.
Primary Skin Irritation	Standard Biocompatibility Testing	No primary skin irritant reactions.
Skin Sensitization (Allergic Contact Dermatitis)	Standard Biocompatibility Testing	No sensitization reactions.
Residual Powder Test	ASTM D-6124-06 (for "powder-free" claims)	Contains no more than 2 mg powder per glove.

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

Test Set Sample Size:
- For physical and dimensions testing: Inspection Level S-2, AQL 4.0. (Specific number not provided, but these are statistical sampling plans.)
- For FDA 1000 ml. Water Fill Test: Inspection Level G-1, AQL 2.5. (Specific number not provided, but these are statistical sampling plans.)
- For Primary Skin Irritation and Skin Sensitization: Not specified.
- For Residual Powder Test: Not specified (but for powder at finished inspection to ensure "powder-free" claims).
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). These are laboratory tests conducted on samples of the manufactured gloves.

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

This is not applicable to the non-clinical testing of examination gloves. The "ground truth" or acceptance criteria are based on established ASTM standards and FDA requirements, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set:

Not applicable. Performance is measured against physical and chemical standards, not 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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

The "ground truth" for the tests mentioned are the established ASTM standards and FDA requirements for glove performance (e.g., tensile strength, elongation, dimensions, freedom from pinholes, biocompatibility, residual powder limits).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set. The manufacturing process is implicitly "trained" through quality control and adherence to standards, but not in the AI/ML sense.

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

Not applicable.

Summary

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KO92294

EXHIBIT #I Page I of 2

510(K) SUMMARY

OCT 2 1 2009

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: __

1. Submitter's Identification:

Mr. Guixi Liu Better Care Plastic Products Co., Ltd Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province 050000

Date Summary Prepared: June 30, 2009

2. Name of the Device:

Better Care Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color

3. Predicate Device Information:

Grand Work Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color (K061562)

4. Device Description:

5. Intended Use:

A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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6. Comparison to Predicate Devices:

Better Care Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color is substantially equivalent in safety and effectiveness to the Grand Work Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves (Blue Color)

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:

The standards used for Better Care Plastic Products Co., Ltd.'s glove product are bassed on ASTM D-5250-06e1. All testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AQL 4.0.

The FDA 1000 ml. Water Fill Test based on ASTM DS151-06 was also conducted with samplings of AQL 2.5, inspection level G-1, 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 on our labels.

A Residual Powder Test that based on ASTM D-6124-06 for powder at finished inspection 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:

Better Care Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color conform fully to ASTM D-5250-06e1 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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Image /page/2/Picture/1 description: The image shows a black and white seal for the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." is arranged in a circular pattern around the bird symbol. The bird symbol is a stylized representation of a human figure embracing a bird.

Public Health Service

DEC 16 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

BetterCare Plastic Products Company, Limited C/O Ms. Jic Liu Project Manager Surprotect, Incorporated 3973 Schaefer Avenue Chino, California 91710

Re: K092294

Trade/Device Name: Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color Regulation Number: 21CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ. Dated: September 30, 2009 Received: October 1, 2009

Dear Ms. Liu:

This letter corrects our substantially equivalent letter of October 21, 2009.

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 (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 cither 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. Liu

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 (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony O. Nockton

Susan Runner, D.D.S., M.A. Acting 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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Attachment A

INDICATION FOR USE

KD92094 510(K) NUMBER (IF UNKNOW): APPLICANT: Better Care Plastic Products Co., Ltd. DEVICE NAME: Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color

INDICATIONS FOR USE:

A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Count Use J (Optional Format 1-2-96)

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

Phil. A.M. Huidiza

oncurrent of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K092294

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.