(41 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 EXAMINATION GLOVES, COLOR: WHITE
The document describes the summary of a 510(k) premarket notification for "Powder-Free Poly-Vinyl Examination Gloves, Color: White" by GLORMED INTERNATIONAL, INC. This device is classified as a Class I medical device (80LYZ) and is intended for medical purposes to prevent contamination between patient and examiner.
The submission focuses on demonstrating substantial equivalence to previously marketed devices (K002340 and K992979) rather than presenting a detailed de novo device study. Therefore, the information regarding acceptance criteria, study details, and specific performance metrics for this particular device is limited to compliance with established standards.
Here's an breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| ASTM D 5250-00 | Met or exceeded |
| ASTM D 6124-00 | Met or exceeded |
| ASTM D 5151-00 | Met or exceeded |
| Bio-Burden IEST-RP-CC005-2 | Met or exceeded |
| Bio-Compatibility: Dermal Sensitization | Met or exceeded |
| Bio-Compatibility: Primary Skin Irritation | Met or exceeded |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing appears to have been conducted to demonstrate compliance with the listed ASTM and IEST-RP standards, which would typically involve testing a sample of the manufactured gloves.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable and not provided in the document. The device is a patient examination glove, and its performance is evaluated against material and biocompatibility standards, not by expert interpretation of clinical data or images.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Performance is measured against predefined technical and biological standards, not through adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted or reported. This type of study is typically relevant for interpretative devices (e.g., imaging software) where human readers' performance is influenced by the device. For examination gloves, the focus is on material properties and safety.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable and not provided. The device is a physical product (gloves), not an algorithm or software. Its performance is inherent in its physical and chemical properties.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on established industry standards and tests for physical properties (e.g., tear resistance, tensile strength – implied by ASTM standards mentioned) and biological safety (biocompatibility tests).
8. Sample Size for the Training Set
This information is not applicable and not provided. The device is not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided as there is no training set for this type of device.
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6 2002 Jun
510(k) SUMMARY
| Submitted For: | GLORMED INTERNATIONAL, INC. |
|---|---|
| Submitted By: | TUCKER & ASSOCIATESOfficial Correspondent for Glormed InternationalJANNA P. TUCKER, President-CEO198 Avenue de la D'emeraldSparks, NV 89434-9550775-342-2612Phone:Fax:775-342-2613E-Mail:Tuckerjan(@aol.com |
| Date of Submission: | 22 April 2002 |
| Device Name: | POWDER-FREE POLY-VINYL EXAMINATIONGLOVES, COLOR: WHITEClass I Device, 80LYZ |
| Proprietary Name: | (Multiple Labels) Powder-Free Poly-Vinyl ExamGloves, 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 manufactured byGlormed Int'l (K002340) and Shanghai Poseidon PlasticProducts Company, Ltd. (K992979). |
EXHIBIT L
Page 48 of 49
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KO21353
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 6124-00 ASTM D 5151-00
Bio-Burden IEST-RP-CC005-2
Bio-Compatibility: Dermal Sensitization Primary Skin Irritation
Conclusion:
This device is substantially equivalent to the devices Approved as K002340 and K9922979.
EXHIBIT L
Page 49 of 49
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the basic outline of the face visible.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Glormed International, Incorporated C/O Ms Janna Tucker Tucker & Associates 198 Avenue De La D'Emerald Sparks. Nevada 89434
Re: K021353
Trade/Device Name: Powder-Free Vinyl Examination Gloves, Color White Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: April 26, 2002 Received: April 26, 2002
6 2002
JUN
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 (OS) 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
16021353
APPLICANT:
GLORMED INTERNATIONAL, INC.
510(k) NUMBER:
DEVICE NAME:
POWDER-FREE POLY-VINYL 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)
Olin S. Lin
(Division Sign-Off)
EXHIBIT B
Page 2 of
nd General Hospital Infection C
i Ojk) 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.