(35 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, Class I Device, 80LYZ
This is a 510(k) Summary for Powdered Vinyl Exam Gloves.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| ASTM D 5250-00E4 | Met or exceeded standard |
| ASTM D 5151-99 | Met or exceeded standard |
| ASTM D 6124-01 | Met or exceeded standard |
| ISO 2859 | Met or exceeded standard |
| MIL Std 105E | Met or exceeded standard |
| Bio-Compatibility: Dermal Sensitization | Met or exceeded standard |
| Bio-Compatibility: Primary Skin Irritation | Met or exceeded standard |
| Bio-Burden (Procedure Method 8315) | Met or exceeded standard |
2. Sample Size for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the evaluations were based on standardized performance tests rather than expert interpretation of medical data or images.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluations were based on standardized performance tests rather than human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a medical glove, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not conducted as this device is a medical glove, not an algorithm.
7. Type of Ground Truth Used
The ground truth used was based on the objective measurements and pass/fail criteria defined by the listed industry and regulatory standards (ASTM, ISO, MIL Std, and bio-compatibility tests).
8. Sample Size for the Training Set
This information is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is not an AI/ML algorithm and therefore does not have a training set. The "ground truth" for demonstrating performance was established by the predefined specifications within the referenced ASTM, ISO, and MIL standards, and bio-compatibility testing procedures.
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MAY - 2 2003
510(k) SUMMARY
| Submitted For: | HEYUAN HONGLI INDUSTRIES, 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: | 25 March 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) K022305. |
EXHIBIT J
Page 49 of 50
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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 5250-00E4 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 K022305.
EXHIBIT J
Page 50 of 50
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2003
Heyuan Hongli Indsustries, Incorporated C/O Ms. Janna P. Tucker Tucker & Associates 198 Avenue De La D'emerald Sparks. Nevada 89434-9550
Re: K030997
Trade/Device Name: Powdered Vinyl Examination Gloves, White Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: March 25, 2003 Received: March 28, 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.
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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 your 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.
Simi Rurrer
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
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INDICATIONS FOR USE
HEYUAN HONGLI INDUSTRIES, INC. APPLICANT:
510(k) NUMBER:
K 030997
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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K030997 |
Prescription Use ____ (Per 21 CFR 801.109) OR Over-The-Counter Use ____ (Optional Format 1-2-96)
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.