(18 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: WHITE
This submission is for "POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE". The device is a Class I medical device (80LZA).
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| ASTM D 5250-00 | Met or exceeded |
| ASTM D 5151-00 | Met or exceeded |
| ASTM D 6124-00 | Met or exceeded |
| Bio-Burden | Met or exceeded |
| Bio-Compatibility: Dermal Sensitization | Met or exceeded |
| Primary Skin Irritation | Met or exceeded |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective). The studies refer to meeting or exceeding ASTM standards and biocompatibility tests, which imply a defined methodology within those standards for sample selection and testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The device is an examination glove, and its performance is assessed against technical standards (ASTM) and biological safety tests (biocompatibility, bio-burden), rather than requiring expert interpretation of diagnostic output to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for this type of device and study. The testing involves laboratory measurements against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices where human readers interpret medical images or data. The device in question is an examination glove.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done. The device is a physical product (examination glove), not an algorithm or AI system. Its performance is assessed through physical and biological testing.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is defined by the specifications and pass/fail criteria outlined in the referenced ASTM standards (D 5250-00, D 5151-00, D 6124-00) and the acceptable levels for Bio-Burden, Dermal Sensitization, and Primary Skin Irritation. These standards represent scientifically established benchmarks for glove quality and safety.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product, not an AI or machine learning model that requires a 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 device.
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JUL = 2 2002
Ko21961
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: | 10 June 2002 |
| Device Name: | POWDER-FREE POLY-VINYL EXAM GLOVES,COLOR: WHITEClass I Device, 80LZA |
| Proprietary Name: | (Multiple Labels) Powder-Free Poly-Vinyl Exam Gloves,Color: White |
| 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. Except for color, itis substantially Equivalent to the devices manufacturedby Shanghai Poseidon Plastic Products Company Limited,(K992979) and Glormed International (K002340) |
EXHIBIT L
Page 50 of 51
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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:
Except for color, this device is substantially equivalent to the devices approved as K992979 and K002340
EXHIBIT L
Page 51 of 51
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of an eagle with three profiles, suggesting a focus on people and health.
JUL = 2 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: K021961
Trade/Device Name: Powder-Free Poly-Vinyl Examination Gloves, White Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: June 10, 2002 Received: June 14, 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 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.
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,
Timothy 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
COPIOUMED INTERNATIONAL, INC. APPLICANT: K021961 510(k) NUMBER: POWDER-FREE POLY-VINYL DEVICE NAME: EXAMINATION GLOVES, COLOR: WHITE
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)
Qlin S. Lim
EXHIBIT B
Page 2 of 51
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 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.