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-5250-00E4.

AI/ML Overview

The document is a 510(k) Pre-market Notification for a medical device: Ever Light Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves-Powdered. It focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating AI performance. Therefore, many of the requested categories related to AI studies, multi-reader multi-case studies, and ground truth for AI training and testing are not applicable.

Here's the information that can be extracted from the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Study Type
Conforms to ASTM D-5250-00E4	Meets all requirements for physical and dimension testing.	Non-Clinical, based on ASTM D-5250-00E4
FDA 1000 ml. Water Fill Test requirements (AQL 2.5, inspection level I)	Meets these requirements.	Non-Clinical, FDA 1000 ml. Water Fill Test
No primary skin irritant reactions	Results showed no primary skin irritant reactions.	Non-Clinical, Primary Skin Irritation testing
No sensitization reactions (allergic contact dermatitis)	Results showed no sensitization reactions.	Non-Clinical, Skin Sensitization testing
Residual Powder Test (no more than 10mg/dm2) based on ASTM D-6124-01	Meets the "powdered" claims (implied to be ≤ 10mg/dm2).	Non-Clinical, Residual Powder Test based on ASTM D-6124-01
Biocompatibility requirements	Meets biocompatibility requirements.	Non-Clinical (implied by skin irritation/sensitization tests)
Labeling claims	Meets labeling claims.	Non-Clinical

Study Details

Sample size used for the test set and the data provenance:
- For ASTM D-5250-00E4 compliance and FDA Water Fill Test, inspection levels, and AQL (Acceptable Quality Level) are mentioned:
  - ASTM testing: Inspection level S-2, AQL 4.0
  - Water Fill Test: AQL 2.5, inspection level I
- Specific raw sample sizes (number of gloves) are not explicitly stated, but these AQL and inspection levels define the sampling plan used.
- Data Provenance: The device is manufactured by Ever Light Products Co., Ltd. in Hebei, China. The testing was performed by them or on their behalf. The data is retrospective in the sense that it's performed on manufactured batches of gloves.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a physical device testing, not an AI evaluation requiring human expert ground truth.
Adjudication method for the test set:
- Not applicable. Results are based on objective physical and chemical tests against defined 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 document describes a physical medical device (gloves), not an AI-powered diagnostic or assistive technology.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document describes a physical medical device (gloves), not an AI algorithm.
The type of ground truth used:
- Objective physical and chemical standards: The "ground truth" for the performance of the gloves is established by predefined standardized tests and limits (e.g., ASTM D-5250-00E4, FDA 1000 ml. Water Fill Test requirements, ASTM D-6124-01 for residual powder, and biocompatibility standards measured by irritation/sensitization tests).
The sample size for the training set:
- Not applicable. This is not an AI study requiring a training set. The "training" in a manufacturing context would refer to process parameters and quality control, not data used to train an algorithm.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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K060784

1 2006 MAY

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: -----------------------------------------------------------------------------------------------------------------------------------------------

l. Submitter's Identification:

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

Date Summary Prepared: March 16, 2006

2. Name of the Device:

Ever Light Plastic Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves-Powdered

3. Predicate Device Information:

Shijiazhuang Great Eagle Plastic Products Co., Ltd Powdered Vinyl Patient Examination Gloves (K983645)

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-5250-00E4.

5. Intended Use:

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6. Comparison to Predicate Devices:

Ever Light Plastic Products Co., Ltd.'s Synthetic Vinyl Patient Examination Gloves-Powdered is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd.'s Powdered 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 "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:

Ever Light Plastic Products Co., Ltd.'s Synthetic Vinyl Patient Examination Gloves-Powdered 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2006 MAY

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

Re: K060784

Trade/Device Name: Synthetic Vinyl Patient Examination Glove-Powdered Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: March 16, 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,

Sufite Y. Bxchan O.m.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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INDICATION FOR USE

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

Even Light Plastic Prodcuts Co., Ltd. Synthetic Vinyl Patient Examination Glove-Powdered.

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)

Shula A. Murphy Lo

11.esiblogy, General Hospital oniol. Dental Devices

K860784

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.