(13 days)
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.
POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study conducted for the Powder-Free Poly-Vinyl Exam Gloves:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| ASTM D 5250-00 (Vinyl Patient Examination Gloves) | Met or exceeded |
| ASTM D 5151-00 (Detection of Holes in Medical Gloves) | Met or exceeded |
| ASTM D 6124-00 (Residual Powder on Medical Gloves) | Met or exceeded |
| Bio-Burden Data | Met or exceeded |
| Bio-Compatibility: Dermal Sensitization | Met or exceeded |
| Bio-Compatibility: Primary Skin Irritation | Met or exceeded |
2. Sample Size for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each of the tests (ASTM D 5250-00, D 5151-00, D 6124-00, Bio-Burden, Dermal Sensitization, Primary Skin Irritation). For medical device testing, these ASTM standards and biocompatibility tests typically involve specific sample size requirements.
The data provenance is also not explicitly stated. While the manufacturer is based in Taiwan, and the submitter is in the US, the location where the tests were performed is not mentioned. The document does not indicate whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
The document does not mention using experts to establish ground truth for the test set. The tests performed are objective, laboratory-based tests against established ASTM standards and biological safety criteria. These types of tests do not typically rely on subjective expert consensus for "ground truth" in the same way an imaging diagnostic algorithm might.
4. Adjudication Method for the Test Set:
An adjudication method is not applicable here. The tests are objective, with pass/fail criteria based on the specified ASTM standards and biological safety assessments. There is no subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images and the AI's impact on their performance is evaluated. The device in question is a patient examination glove, and its performance is assessed through physical and biological property testing, not diagnostic interpretation.
6. Standalone Performance Study:
Yes, a standalone study was done. The entire set of tests listed (ASTM D 5250-00, ASTM D 5151-00, ASTM D 6124-00, Bio-Burden, Dermal Sensitization, Primary Skin Irritation) represents the standalone performance evaluation of the device. These tests were conducted on the gloves themselves to demonstrate that they meet the specified standards and safety requirements. The performance reported in the table reflects the algorithm-only (device-only) performance against the established criteria.
7. Type of Ground Truth Used:
The "ground truth" for the performance evaluation is based on established industry standards and biological safety criteria.
- ASTM D 5250-00, D 5151-00, D 6124-00: These are ground truths based on published consensus standards for material properties, barrier integrity, and residual powder.
- Bio-Burden: Ground truth would be acceptable limits for microbial contamination.
- Bio-Compatibility (Dermal Sensitization, Primary Skin Irritation): Ground truth is established biological safety thresholds and responses (e.g., absence of irritation or sensitization reactions in test subjects/models).
8. Sample Size for the Training Set:
This information is not applicable/not provided. The device is a physical product (examination gloves), not an artificial intelligence or machine learning algorithm that requires a "training set" of data. The manufacturing process itself is implicitly 'trained' through quality control and process validation, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" for this type of device.
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JUN 1 0 2002
510(k) SUMMARY
| Submitted For: | COPIOUMED INTERNATIONAL, INC.6f-1, No. 169-12, Sec. 2Chang AN East RoadTaipei, Taiwan, ROC |
|---|---|
| Submitted By: | TUCKER & ASSOCIATESOfficial Correspondent for Copioumed International, Inc.JANNA P. TUCKER, President-CEO198 Avenue de la D'emeraldSparks, NV 89434-9550 |
| Phone: | 775-342-2612 |
| Fax: | 775-342-2613 |
| E-Mail: | Tuckerjan@aol.com |
| Date of Submission: | 20 May 2002 |
| Device Name: | POWDER-FREE POLY-VINYL EXAM GLOVES,COLOR: YELLOWClass I Device, 80LZA |
| Proprietary Name: | (Multiple Labels) Powder-Free Poly-Vinyl Exam Gloves,Color: Yellow |
| Labels/Labeling: | This device will be marketed to healthcare professionals atDentist and Doctor Offices, Laboratories, Clinics andHospitals through its distributors for the intended use. |
| Intended Use: | A patient examination glove is a disposable device intendedfor medical purposes that is worn on the examiner's handor finger to prevent contamination between patient andexaminer. |
| Substantial Equivalence: | Both in its intended use and/or physicalcharacteristics, this device is equivalent to devicescurrently marketed by U.S. companies. It is substantiallyEquivalent to the devices manufactured by ShanghaiPoseidon Plastic Products Company Limited, (K992979)and Glormed International (K002340) |
EXHIBIT L
Page 45 of 46
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510k) Summary page 2.
Test Results (Means and/or Successful Results:
This device has met or exceeded the following standards and/or tests:
ASTM D 5250-00 ASTM D 5151-00 ASTM D 6124-00 Bio-Burden
Bio-Compatibility: Dermal Sensitization Primary Skin Irritation
Conclusion:
This device is substantially equivalent to the devices Approved as K992979 and K002340
EXHIBIT L
Page 46 of 46
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle with three lines representing its wings and head.
Public Health Service
JUN 1 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Copioumed International, Incorporated C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D' Emerald Sparks. Nevada 89434-9550
Re: K021743
Trade/Device Name: Powder-Free Poly-Vinyl Examination Gloves, Color Yellow Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: May 20, 2002 Received: May 28, 2002
Dear Ms. Tucker:
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 vour 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.
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.
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Page 2 - Ms. Tucker
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours
Tim A. Utterback
Timt th A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
APPLICANT: COPIOUMED INTERNATIONAL, INC. 14021743 510(k) NUMBER: DEVICE NAME: POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Optional)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 510:k) Number
§ 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.