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, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.

AI/ML Overview

The provided text describes the regulatory submission for the "Ever Light Plastic Products Co., Ltd. Synthetic (Yellow) Vinyl Patient Examination Gloves-Powder Free." This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria in the context of, for example, an AI/ML medical device, is largely not applicable to this submission. The device is a patient examination glove, and its evaluation relies on established standards for physical properties and biocompatibility, not on AI-driven performance metrics.

Below, I've addressed the relevant sections based on the available information and indicated where the requested details are not applicable.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance (as stated in the document)
Physical & Dimensions	ASTM D-5250-00E4 requirements	"All testing meets requirements for physical and dimensions testing conducted on gloves."
Pinhole/Barrier Integrity	FDA 1000 ml. Water Fill Test	"The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level I, meeting these requirements."
Residual Powder	ASTM D-6124-01 for Starch	"Our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per glove)."
Primary Skin Irritation	Not explicitly stated standard	"Results showing no primary skin irritant reactions."
Skin Sensitization	Not explicitly stated standard	"Results showing no...sensitization reactions."
Biocompatibility	Not explicitly stated	"Conform fully to...biocompatibility requirements." (This is a summary statement, not specific test results in this section, but implied by the irritation/sensitization testing).

Additional Requested Information:

This section will address the remaining points, noting their applicability to a medical glove submission.

Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size:
  - For Physical & Dimensions testing: "Inspection level S-2, AQL 4.0." (ASTM D-5250-00E4)
  - For Water Fill Test: "samplings of AQL 2.5, inspection level I."
  - For Primary Skin Irritation and Skin Sensitization: Not specified, but implied to be sufficient for a "no primary skin irritant or sensitization reactions" conclusion.
  - For Residual Powder Test: Not specified, but implied to be sufficient to "insure that our gloves meet our 'powder-free' claims."
- Data Provenance: Not explicitly stated beyond the tests being conducted for the submitter, Ever Light Plastic Products Co., Ltd., which is based in Hebei, China. The tests are assumed to be prospective, carried out on samples from the manufacturing process.
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. For medical gloves, "ground truth" is established by adherence to recognized industrial standards (ASTM) and regulatory requirements (FDA water fill test, biocompatibility). These criteria are objective measurements, not subjective interpretations by medical experts in fields like radiology.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., image review by radiologists). For the objective tests performed on gloves (e.g., tensile strength, dimensions, pinhole detection, chemical residue), no such adjudication is necessary. The results are quantitative and directly compared against the specified limits in the standards.
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 patient examination glove and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is irrelevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical medical product (gloves), not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is based on objective measurements against established engineering and safety standards (e.g., ASTM D-5250-00E4 for physical properties, ASTM D-6124-01 for residual powder, FDA's water fill test for barrier integrity, and biocompatibility testing for skin irritation/sensitization). There is no "expert consensus" or "pathology" in the sense of diagnostic interpretation for a glove.
The sample size for the training set
- Not Applicable. This device is a physical product, not a machine learning model; therefore, there is no "training set."
How the ground truth for the training set was established
- Not Applicable. As there is no training set for a physical device like a glove, this question is not relevant.

Summary

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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 8807.92.

14060786 The assigned 510(K) number is:

1. Submitter's Identification:

Mr. Yang Ying Ever Light Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei, China 050000

Date Summary Prepared: March 10, 2005

2. Name of the Device:

Ever Light Plastic Products Co., Ltd. Synthetic (Yellow) Vinyl Patient Examination Gloves-Powder Free

3. Predicate Device Information:

Shijiazhuang Great Eagle Plastic Products Co., Ltd Synthetic Powder-Free (Yellow) Vinyl Patient Examination Gloves (K992861)

4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all

requirements of ASTM standard D-5250-00E4.

5. Intended Use:

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EXHIBIT #1 Page 2 of 2 K060786

6. Comparison to Predicate Devices:

Ever Light Plastic Products Co., Ltd.'s Synthetic (Yellow) Vinyl Patient Examination Gloves-Powder Free is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd.'s Synthetic Powder-Free (Yellow) Vinyl Patient Examination Gloves.

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

The standards used for Ever Light 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-6124-01 for Starch 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. 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:

Ever Light Plastic Products Co., Ltd.'s Synthetic (Yellow) Vinyl Patient Examination Gloves-Powder Free conform fully to ASTM D-5250-00E4 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 the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping lines that resemble a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY -8 2006

Ever Light Plastic Products Company Limited C/O Ms. Kathy Liu Official Correspondent for Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710

Re: K060786

Trade/Device Name: Even Light Plastic Products Co. Ltd. Synthetic (Yellow) Vinyl Patient Examination Glove-Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: March 10, 2006 Received: March 22, 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.

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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); 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.

Chih Lin, Ph.D.

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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Attachment A

INDICATION FOR USE

510 (k) NUMBER (IF KNOW): K060786 APPLICANT: DEVICE NAME:

Even Light Plastic Prodcuts Co., Ltd. Synthetic (Yellow) Vinyl Patient Examination Glove-Powder Free.

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)

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)

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

K Number: K060786

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.