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-5250-06.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Vinyl Patient Examination Glove, Yellow:

This document is a 510(k) summary for a medical device (patient examination glove) and focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel efficacy through detailed clinical studies. Therefore, many of the requested points related to advanced AI/ML studies (like MRMC, effect size, training sets, and detailed ground truth establishment for a complex algorithm) are not applicable in this context. The "acceptance criteria" here mainly refer to meeting established physical, chemical, and biocompatibility standards for gloves.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Physical Dimensions	ASTM D-5250-06 (all requirements)	"All testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AQL 4.0."
Pinholes (Barrier Integrity)	FDA 1000 ml. Water Fill Test, AQL 2.5, inspection level I	"The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level I, meeting these requirements."
Biocompatibility	Primary Skin Irritation and Skin Sensitization testing	"Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions."
Powder Content	ASTM D-6124-06 (no more than 2 mg powder per glove)	"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 'powder-free' claims (contain no more than 2 mg powder per glove)."
General Compliance	Applicable 21 CFR references	"Hong Di Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves, Yellow conform fully to ASTM D-5250-06 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."

Study Details (as applicable for this type of device submission)

Sample size used for the test set and the data provenance:
- Test Set Sample Size:
  - For Physical/Dimensions Testing: Inspection level S-2, AQL 4.0 (specific sample size from a lot is not explicitly stated but is derivable from the AQL tables).
  - For Pinhole (Water Fill) Test: AQL 2.5, inspection level I (specific sample size from a lot is not explicitly stated but is derivable from the AQL tables).
  - For Biocompatibility Testing: Not specified, but standard animal or human patch test panels are typically used for irritation/sensitization.
  - For Residual Powder Test: Not specified, but samples from batches would be tested.
- Data Provenance: The tests were conducted by the manufacturer, Hong Di Plastic Products Co., Ltd., in China. The data would be prospective from their manufacturing and quality control processes.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For this type of device, "ground truth" is established by adherence to recognized industrial standards (ASTM) and FDA test methods. There are no "experts" in the sense of clinical reviewers establishing a diagnostic "ground truth" for the device's performance, but rather qualified lab personnel performing standardized tests.
Adjudication method for the test set:
- Not Applicable. The "adjudication" is essentially the pass/fail criteria defined by the ASTM standards and FDA test methods (e.g., AQL levels for defects, negative results for irritation/sensitization). There's no consensus-based adjudication as would be seen in reading medical images.
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, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (glove), not an algorithm.
The type of ground truth used:
- Standardized Test Results & Compliance to Specifications: The "ground truth" for this device is its performance against established, quantitative specifications outlined in ASTM standards (D-5250-06, D-6124-06) and FDA-mandated tests (1000 mL Water Fill, biocompatibility assays).
The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a training set. The "training" for manufacturing involves process control and adherence to quality systems for all produced gloves.
How the ground truth for the training set was established:
- Not Applicable. As above, no training set in the AI/ML sense. "Ground truth" for manufacturing process quality is established through ongoing quality control and adherence to Good Manufacturing Practices (GMPs) and the specified ASTM standards throughout the production lifecycle.

Summary

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MAR 1 9 2007

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:

1. Submitter's Identification:

Mr. Qiao Zhiqiang Hong Di Plastic Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei, China 050000

Date Summary Prepared: January 14, 2007

Name of the Device:

Hong Di Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves, Yellow

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-5250-06.

5. Intended Use:

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6. Comparison to Predicate Devices:

Hong Di Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves, Yellow- 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 Hong Di Plastic Products Co., Ltd.'s glove production are based on ASTM-D-5250-06. 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 "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:

Hong Di Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves, Yellow conform fully to ASTM D-5250-06 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 U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms reaching upwards, enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2007

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

Re: K070188

Trade/Device Name: Powder Free Vinyl Patient Examination Glove, Yellow Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: March 12, 2007 Received: March 13, 2007

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

Sincerely yours,

Clive Liu, 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): APPLICANT: DEVICE NAME:

Kolo188 Hong Di Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Glove, Yellow.

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)

Shule H. Murphy, D

diston of Anesthesiology, General Hospital, Control, Dental Devices

V) Number ....................................................................................................................................................................

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.