(24 days)
Not Found
No
The device description and intended use clearly define a standard examination glove, with no mention of AI/ML or related technologies. The performance studies focus on material properties and biocompatibility, not algorithmic performance.
No
The device, a patient examination glove, is intended to prevent contamination, not to treat a medical condition or ailment.
No
Explanation: The device is a patient examination glove, described as being worn to prevent contamination. Its function is protective, not diagnostic.
No
The device is a physical examination glove, which is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description reinforces the intended use as a barrier device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical properties and biocompatibility of the glove, not on diagnostic accuracy.
- Predicate Device: The predicate device (K021961) is also a patient examination glove, which are not classified as IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
LYZ
Device Description
POWDERED VINYL EXAM GLOVES, WHITE
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals at Dentist and Doctor Offices, Laboratories, Clinics and Hospitals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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)
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
APR 1 7 2003
| KO30927 | |
|---|---|
| 510(k) SUMMARY | |
| Submitted For: | COPIOUMED INTERNATIONAL, INC. |
| Submitted By: | TUCKER & ASSOCIATES |
| Official Correspondent for COPIOUMED | |
| JANNA P. TUCKER, President-CEO | |
| 198 Avenue de la D'emerald | |
| Sparks, NV 89434-9550 | |
| Phone: | |
| 775-342-2612 | |
| Fax: | |
| 775-342-2613 | |
| E-Mail: | |
| Tuckerjan@aol.com | |
| Date of Submission: | 19 March 2003 |
| Device Name: | POWDERED VINYL EXAM GLOVES, |
| WHITE | |
| Class I Device, 80LYZ | |
| Proprietary Name: | (Multiple Private Labels) |
| Labels/Labeling: | This device will be marketed to healthcare professionals at |
| Dentist and Doctor Offices, Laboratories, Clinics and | |
| Hospitals through its distributors for the intended use. | |
| Intended Use: | 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. | |
| Substantial Equivalence: | Both in its intended use and/or physical |
| characteristics, this device is equivalent to devices | |
| currently marketed by U.S. companies. Except for U.S.P. | |
| powder, it is the exact same glove manufactured in | |
| approved 510(k) K021961. |
EXHIBIT K
Page 49 of 50
1
510k) Summary page 2.
HO30927
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 K021961.
EXHIBIT K
Page 50 of 50
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines beneath them.
APR 1 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
COPIOUMED International, Incorporated C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D' emerald Sparks, Nevada 89434-9550
Re: K030927
Trade/Device Name: Powdered Vinyl Examination Gloves, White Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: March 19, 2003 Received: March 24, 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 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 vours.
Susan Runres
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
COPIOUMED INTERNATIONAL, INC. APPLICANT:
510(k) NUMBER: - Ko30927
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_$\checkmark$
(Optional Format 1-2-96)
Olen Slim
sthesiology, General Hospital
510(k) Number: K030927
EXHIBIT B
Page 2 of 50