(64 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.
POWDERED VINYL EXAM GLOVES, WHITE
This document describes the acceptance criteria and study proving a device meets these criteria. The device is 'Powdered Vinyl Exam Gloves, White' (K031104) from Glormed International, Inc.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| ASTM D 5250-00E4 | Met or Exceeded |
| ASTM D 5151-99 | Met or Exceeded |
| ASTM D 6124-01 | Met or Exceeded |
| ISO 2859 | Met or Exceeded |
| MIL Std 105E | Met or Exceeded |
| Bio-Compatibility: Dermal Sensitization | Met or Exceeded |
| Bio-Compatibility: Primary Skin Irritation | Met or Exceeded |
| Bio-Burden (Procedure Method 8315) | Met or Exceeded |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test. However, the tests referenced are recognized industry standards for gloves.
- Data Provenance: The document does not specify the country of origin of the data. It implies the data was collected as part of the regulatory submission process. The study appears to be prospective in the sense that the tests were conducted specifically to demonstrate compliance for this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The "ground truth" for this type of device is established by meeting the specified performance standards rather than expert consensus on individual observations.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation is based on objective measurements against established technical standards, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed and is not relevant for this type of medical device (examination gloves). Such studies are typically conducted for diagnostic imaging devices where human interpretation plays a role.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study is not applicable as this is a physical medical device (gloves), not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth used for this device is based on objective measurements and adherence to established industry-specific performance standards (e.g., ASTM, ISO, MIL Std for physical properties, and specific bio-compatibility tests). There is no "expert consensus," "pathology," or "outcomes data" in the conventional sense for proving the functional performance of examination gloves.
8. Sample Size for the Training Set
There is no training set for this type of device. The device's performance is evaluated against predefined standards, not by training an algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this device.
{0}------------------------------------------------
Kos1104
JUN 1 0 2003
510(k) SUMMARY
| Submitted For: | GLORMED INTERNAIONAL, INC. |
|---|---|
| Submitted By: | TUCKER & ASSOCIATESOfficial Correspondent for COPIOUMEDJANNA P. TUCKER, President-CEO198 Avenue de la D'emeraldSparks, NV 89434-9550Phone:775-342-2612Fax:775-342-2613E-Mail:Tuckerjan@aol.com |
| Date of Submission: | 2 April 2003 |
| Device Name: | POWDERED VINYL EXAM GLOVES,WHITEClass I Device, 80LYZ |
| Proprietary Name: | (Multiple Private Labels) |
| 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 U.S.P.powder, it is the exact same glove manufactured inapproved 510(k) KO21353. |
EXHIBIT K
Page 49 of 50
{1}------------------------------------------------
KO31104
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 5250-00E4 ASTM D 5151-99 ASTM D 6124-01 ISO 2859 MIL Std 105E Bio-Compatibility: Dermal Sensitization Primary Skin Irritation Bio-Burden (Procedure Method 8315)
Conclusion: Except for the U.S.P. powder, this device is the same glove as approved in K021353.
EXHIBIT K
Page 50 of 50
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The seal is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2003
Glormed International, Incorporated C/O Ms. Janna P. tucker Tucker & Associates 198 Avenue de la D' emerald Sparks, Nevada 89434-9550
Re: K031104
Trade/Device Name: Powdered Vinyl Examination Gloves, White Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: April 2, 2003 Received: April 30, 2003
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.
{3}------------------------------------------------
Page 2 - Ms. Tucker
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 vour 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 (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 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Reusse
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE
GLORMED INTERNATIONAL, INC. APPLICANT:
KO31104
510(k) NUMBER:
POWDERED VINYL EXAM GLOVES, DEVICE NAME: 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__________________________________________________________________________________________________________________________________________________________
Olin S. him. (Opti
(Optional Format 1-2-96)
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D
510(k) Number: K031104
EXHIBIT B
Page 2 of 50
§ 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.