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 contamingtion between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical a 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, Powder Free Vinyl Synthetic Examination Gloves with Aloe Vert Creen Color, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.

AI/ML Overview

The provided text describes a 510(k) summary for "Ever Light Plastic Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color." This document is focused on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study in the way one would for diagnostic or therapeutic devices.

Therefore, many of the typical acceptance criteria and study details requested (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable in this context. This is a Class I medical device (patient examination glove), which typically requires demonstrating adherence to recognized standards and biocompatibility, not clinical performance studies with specific statistical metrics like sensitivity or specificity.

Here's a breakdown of the information that is available based on your request, highlighting where information is not applicable or not provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Test)	Reported Device Performance
ASTM D-5250-00E4 (Physical and Dimensions)	Meets all requirements for physical and dimensions testing. (Inspection level S-2, AQL 4.0)
FDA 1000 ml. Water Fill Test (Pinhole/Barrier Integrity)	Meets requirements. (Sampling AQL 2.5, inspection level I)
Primary Skin Irritation Test	Results showed no primary skin irritant reactions.
Skin Sensitization Test (Allergic Contact Dermatitis)	Results showed no sensitization reactions.
ASTM D-6124-01 (Residual Powder)	Meets "powder-free" claims (contains no more than 2 mg powder per glove).
Biocompatibility Requirements	Meets biocompatibility requirements (specifically mentioned in conclusions, likely supported by the skin irritation/sensitization tests).
Labeling Claims	Meets labeling claims (no special claims, not hypoallergenic).

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

Sample Size:
- For ASTM-D-5250-00E4 (Physical & Dimensions): Inspection level S-2, AQL 4.0. (Specific number of gloves not stated, but defined by the inspection level and AQL for lot acceptance).
- For FDA 1000 ml. Water Fill Test: Sampling AQL 2.5, inspection level I. (Specific number of gloves not stated, but defined by the inspection level and AQL for lot acceptance).
- For Primary Skin Irritation and Skin Sensitization: Not specified (usually involves a number of human subjects or animal models, but specific count not provided).
- For Residual Powder Test: Not specified (usually involves a number of gloves from a batch, but specific count not provided).
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective clinical data). Given it's a device manufactured in China (Ever Light Products Co., Ltd. is based in Hebei, China), the testing would likely have been conducted by the manufacturer or a contracted lab to meet international and US standards. The studies described are non-clinical, related to product quality and safety characteristics, not clinical performance in a patient population.

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

This is not applicable. The ground truth for these types of tests (physical properties, barrier integrity, biocompatibility) is established by the specifications of the ASTM standards and FDA test methods, not by expert consensus on clinical findings. For example, a pinhole is a physical hole, not an interpretation.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for interpreting ambiguous clinical cases, often in diagnostic imaging. The tests described here have objective pass/fail criteria based on measured physical or chemical properties.

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

No. An MRMC study is relevant for diagnostic devices where human readers interpret data (e.g., medical images). This document describes examination gloves, which do not involve human interpretation in this manner.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This question is also not applicable as it pertains to AI/algorithm performance. The device is a physical product (gloves).

7. The Type of Ground Truth Used

The ground truth used is based on objective standards and test methods:
- ASTM Standard D-5250-00E4: Defines acceptable physical dimensions and properties.
- FDA 1000 ml. Water Fill Test: Defines acceptable barrier integrity (absence of pinholes).
- Primary Skin Irritation and Skin Sensitization testing protocols: Define methods and criteria for evaluating biocompatibility.
- ASTM D-6124-01: Defines acceptable levels of residual powder.
- Biocompatibility principles: Informed by scientific understanding of material interaction with the body.

8. The Sample Size for the Training Set

This is not applicable. The device is not an AI/ML algorithm or diagnostic tool that requires a "training set." The testing described relates to quality control and meeting product standards.

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

This is not applicable for the reasons stated in point 8.

Summary

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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: _______________________________________________________________________________________________________________________________________________

1. Submitter's Identification:

JUL - 7 2006

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

Date Summary Prepared: March 14, 2006

2. Name of the Device:

Ever Light Plastic Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color

3. Predicate Device Information:

Shijiazhuang Grand Work Plastic Products Co., Ltd Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color (K042830)

4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder Free Vinyl Synthetic Examination Gloves with Aloe Vert Creen

Color, 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 Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color is substantially equivalent in safety and effectiveness to the Shijiazhuang Grand Work Plastic Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color.

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 Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color conform fully to ASTM D-5250-00E4 stadard 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 seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2006

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

Re: K060785

Trade/Device Name: Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: June 16, 2006 Received: June 19, 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 vours.

Sujit J. Michael, 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

K060185 510 (k) NUMBER (IF KNOW): APPLICANT: Even Light Plastic Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Aloe DEVICE NAME: Vera, Green Color

INDICATIONS FOR USE:

A patient examination glove is disposable device intended for medical a 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

い 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)
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Shula H. Murphy, R.D. 7/16/04
Sign-Off

ion of Anesthesiology, General Hospital,
ion Control, Dental Devices

Number K060785

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.