A 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.

Device Description

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00aE3.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the device, structured to address your specific points:

This document describes the 510(k) submission for a Non-Sterile Powder-Free Blue Nitrile Patient Examination Glove. The information provided focuses on the device's conformance to established standards rather than clinical performance against specific disease conditions.

Acceptance Criteria and Device Performance

A specific table format for acceptance criteria and reported device performance is not explicitly provided in the document. However, the document outlines the standards the device meets and the relevant performance metrics.

Acceptance Criteria (Standard / Test)	Reported Device Performance
ASTM D6319-00aE3	Met all requirements.
Physical & Dimensions Testing	Met requirements for Inspection Level S-2, AQL 4.0.
FDA 1000 ml. Water Fill Test	Met requirements for AQL 2.5, Inspection Level G-1.
Primary Skin Irritation Test	No primary skin irritant reactions.
Skin Sensitization Test	No sensitization reactions (allergic contact dermatitis).
Residual Powder Test (ASTM D6124-01)	Met "powder-free" claim (no more than 2 mg powder per glove).

Study Details

Given this is a 510(k) submission for a patient examination glove, the "study" context differs significantly from, for example, a diagnostic AI device. The "studies" here refer to testing performed to ensure the glove meets established safety and performance standards.

The document does not describe a "test set" in the context of machine learning, but rather samples from the manufactured product undergoing quality control and conformance testing.

Sample size used for the test set and the data provenance:
- Pinhole (FDA 1000 ml. Water Fill Test): Sampling of AQL 2.5, Inspection Level G-1. (Specific numerical sample size not provided, but these AQL levels imply a defined sample size based on lot size).
- Physical & Dimensions Testing: Sampling of Inspection Level S-2, AQL 4.0. (Specific numerical sample size not provided).
- Biocompatibility (Primary Skin Irritation and Skin Sensitization): No specific sample size mentioned for these tests, typically these involve a smaller, controlled number of subjects or animal models as per standard biocompatibility testing protocols.
- Residual Powder Test: No specific sample size mentioned for this test, but it is conducted at "finished inspection."
- Data Provenance: The tests were conducted internally by Shijiazhuang Tillotson Rubber Products Co., Ltd. as part of their production and quality control process. The country of origin for the data is implicitly China, where the manufacturer is located. The nature of these tests is prospective in the sense that they are performed on newly manufactured batches to ensure ongoing compliance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device and submission. The "ground truth" here is defined by objective physical and chemical standards (e.g., specific measurement values, pass/fail criteria for irritation). There are no human "experts" establishing a subjective "ground truth" for interpretations. For the biocompatibility tests, qualified laboratory personnel would interpret the results against established criteria.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, often in image analysis. For glove testing, the results are typically determined by objective measurements and observations against predefined acceptance criteria. For example, a glove either leaks under the water fill test or it doesn't.
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:
- No. An MRMC study is not applicable for this device. This type of study is relevant for diagnostic devices (especially AI-powered ones) where human readers (e.g., radiologists) interpret cases and their performance (with or without AI assistance) is evaluated. This device is a medical glove, not a diagnostic tool requiring interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or basis for acceptance) is established by objective technical standards and laboratory test results. This includes:
  - Physical measurements (e.g., dimensions, tensile strength based on ASTM D6319-00aE3).
  - Performance criteria (e.g., absence of pinholes in the water fill test).
  - Chemical analysis (e.g., residual powder content based on ASTM D6124-01).
  - Biocompatibility observations (e.g., absence of irritation or sensitization reactions in standardized tests).
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set." The manufacturing process is controlled by established engineering and quality management principles, not by training an algorithm on a data set.
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant. The "ground truth" for the overall device's performance as a medical glove is established by its adherence to internationally recognized and FDA-accepted standards like ASTM D6319-00aE3.

Summary

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SEP 2 0 2004

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: _ k_042378

1. Submitter's Identification:

Mr. Yang Ying Shijiazhuang Tillotson Rubber Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei Province P.R. China

Date Summary Prepared: August 30, 2004

2. Name of the Device:

Shijiazhuang Tillotson Rubber Products Co., Ltd. Non-Sterile Powder-Free Blue Nitrile Patient Examination Glove

3. Predicate Device Information:

Tillotson Healthcare Corp.

True Advantage Non-Sterile Powder-Free Blue Nitrile Patient Examination Glove (K013016)

4. Device Description:

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00aE3.

5. Intended Use:

A 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.

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6. Comparison to Predicate Devices:

Shijiazhuang Tillotson Rubber Products Co., Ltd. Non-Sterile Powder Free Blue Nitrile Patient Examination Glove is substantially equivalent in safety and effectiveness to the Tillotson Healthcare Corp. True Advantage Non-Sterile Powder Free Blue Nitrile Patient Examination Glove.

7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:

The standards used for Shijiazhuang Tillotson Rubber Products Co., Ltd. glove production are based on ASTM-D-6319-00aE3. 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 G-1, 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.

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

A Residual Powder Test that based on ASTM D6124-01 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. Discussion of Clinical Tests Performed:

Not Applicable - There is no hypoallergenic Claim.

9. Conclusions:

Shijiazhuang Tillotson Rubber Products Co., Ltd. Non-Sterile Powder Free Blue Nitrile Patient Examination Glove conform fully to ASTM-D-6319-00a€3 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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SEP 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shijiazhuang Tillotson Rubber Products Compamy Limited Mr. James Chu Official Correspondent Gloveco, Incorporated 590 West Central Avenue, #D Brea, California 92821

Re: K042378

R042378
Trade/Device Name: Non-Sterile Powder Free Blue Nitrile Patient Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 1, 2004 Received: September 1, 2004

Dear Mr. Chu:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have rottewou your was 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 Interstate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to ac nove that metic Act (Act) that do not require approval of a premarket the rederal 1 004, Drag, and Sommay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providions of the sistration, 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 If your device is classified (500 as 1011). Existing major regulations affecting (1 Mr), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the becas nouncements concerning your device in the Federal Register.

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Page 2 - Mr. Chu

Please be advised that FDA's issuance of a substantial equivalence determination does not Please oc auvisor that I DT 3 issuainse on that your device complies with other requirements Incall that I DX mas made a actes and regulations administered by other Federal agencies. of the Act of any I oderal blance tax sequirements, including, but not limited to: registration 1 ou must conting (21 CFR Part 801); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 et revers), systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in at a 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) Fins feter will and in Jose Finding of substantial equivalence of your device to a premitset notification. - The Pire 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), If you desite specific at 12 mpliance at (301) 594-4618. 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 may overn 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/dsma/dsmamain.html

Sincerely vours,

Clus

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

INDICATIONS FOR USE

k 042378 510(k) NUMBER (IF KNOWN) : Shijiazhuang Tillotson Rubber Products Co., Ltd. APPLICANT: Non-Sterile Powder Free Blue Nitrile Patient Examination Glove DEVICE NAME:

INDICATIONS FOR USE:

A patient examination glove is disposable device intended for medical purposes 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 X (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)

Kein Muly

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K042378

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.