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 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 I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00€4.

AI/ML Overview

The provided document describes a 510(k) premarket notification for Powdered (White) Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing an AI/ML-based device and its performance. Therefore, the requested information pertaining to acceptance criteria and ground truth for an AI/ML device is not applicable in this context.

Here's a breakdown based on the information available:

The device in question is a medical glove, and the regulatory submission is a 510(k) aiming to show that it is "substantially equivalent" to an already marketed predicate device, not a novel AI/ML device requiring extensive performance studies as described in your request.

Here's why each of your requested points is not applicable or cannot be extracted:

A table of acceptance criteria and the reported device performance:
- Not Applicable: This document describes a physical medical device (gloves) and its compliance with established ASTM standards and FDA requirements for such devices, rather than performance metrics for an AI/ML algorithm. The acceptance criteria relate to physical properties and biocompatibility as per standards.
Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable: The "tests" here are for physical properties, water integrity, and biocompatibility of gloves, not test sets for an AI/ML algorithm. The sample sizes mentioned are for inspection levels for attributes like pinhole defects (AQL 2.5, inspection level I) and residual powder, as well as general physical and dimensional testing (inspection level S-2, AQL 4.0). Data provenance for these types of tests typically refers to where the manufacturing and testing occurred (China, in this case), not detailed data provenance for an algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable: Ground truth as described (expert consensus, pathology) is not relevant for evaluating medical gloves. The acceptance is based on laboratory testing against established physical and biocompatibility standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable: Adjudication methods are for clinical interpretation or labeling of images/data, which is not relevant for this device.
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 type of study is for evaluating diagnostic or interpretive AI/ML tools, not medical gloves.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable: The "ground truth" for medical gloves is adherence to the specifications outlined in standards like ASTM D-5250-00E4 and FDA requirements for pinholes and biocompatibility.
The sample size for the training set:
- Not Applicable: There is no training set for a physical medical device like gloves.
How the ground truth for the training set was established:
- Not Applicable: There is no training set mentioned or implied.

In summary, the provided document describes a regulatory filing for a medical glove, demonstrating its substantial equivalence to a predicate device through conformity to established standards and physical/biocompatibility testing, not an AI/ML-driven medical device. Therefore, the questions related to AI/ML device acceptance criteria and studies do not apply.

Summary

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

SEP 1 8 2006

EXHIBIT #1 Page 1 of 2

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: كيف (OG2 كيج

1. Submitter's Identification:

Mr. Guixi Liu Shijiazhuang Junfei Plastic Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei, China 050000

Date Summary Prepared: August 30, 2006

2. Name of the Device:

Shijiazhuang Junfei Plastic Products Co., Ltd. Powdered (White) Vinyl Patient Examination Gloves

3. Predicate Device Information:

Shijiazhuang Great Eagle Plastic Products Co., Ltd Powdered (White) Vinyl Patient Examination Gloves (K000166)

4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00€4.

5. Intended Use:

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

6. Comparison to Predicate Devices:

Shijiazhuang Junfei Plastic Products Co., Ltd.'s Powdered (White) Vinyl Patient Examination Gloves is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd.'s Powdered (White) Viny) Patient Examination Gloves.

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

The standards used for Shijiazhuang Junfei Plastic Products Co., Ltd.'s glove

production are based on ASTM-D-5250-00E4. 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 was also conducted with samplings of AQL 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.

A Residual Powder Test that based on ASTM D-6124-06 for Starch at finished inspection is conducted to insure that our gloves meet our "powdered" claims (contain no more than 10mg/dm2).

8. Labeling:

There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.

9. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic Claim.

10. Conclusions:

Shijiazhuang Junfei Plastic Products Co., Ltd.'s Powdered (White) Vinyl Patient Examination Gloves conform fully to ASTM D-5250-00€4 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.

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

Image /page/2/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, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 8 2006

Shijiazhuang, Junfei Plastic Products Company Limited C/O Ms. Kathy Liu Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710

Re: K062655

Trade/Device Name: Powdered (White) Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: August 30, 2006 Received: September 8, 2006

Dear Ms. Liu:

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 (Special 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.

{3}------------------------------------------------

Page 2 - Ms. Lin

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

{4}------------------------------------------------

Attachment A

INDICATION FOR USE

KO62652 510 (k) NUMBER (IF KNOW): APPLICANT: Shijiazhuang Junfei Plastic Prodcuts Co., Ltd. DEVICE NAME: Powdered (White) Vinyl Patient Examination Gloves

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-Counter-Use
(Optional Format 1-2-96)

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

Concurrent of CDRH, Office of Device Evaluation (ODE)

	K06263
	Shula Murthy, MD
	9/18/06

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

510(k) Number:	K062635
----------------	---------

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.