(62 days)
Not Found
Not Found
No
The summary describes a simple, disposable finger cot with no mention of AI or ML capabilities.
No
The device, a finger cot, is intended to prevent contamination between patient and examiner, not to provide therapy or treatment for a disease or condition.
No
Explanation: The device is a finger cot, which is used to prevent contamination between patient and examiner and does not perform any diagnostic function.
No
The device description clearly states it is a "Latex Finger Cot," which is a physical, hardware device. There is no mention of software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the examiner's finger. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: A finger cot is a physical barrier device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A finger cot is a disposable device intended for medical purposes that is worn on the examiner's finger to prevent contamination between patient and examiner.
A patient examination glove is a disposable device intended for medical purposes that is to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This device will be marketed to healthcare professionals at dentist, and doctor offices, laboratories, clinics and hospitals through its intended use.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K980827
4 1998 MAY
510(k) SUMMAR Y
| Submitted By: | Janna Tucker & Associates
19001 S. Richfield #185
Green Valley, AZ 85614
Phone: 520-625-2904
FAX: 520-625-3908 | | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Janna P. Tucker, Official Correspondent for
Sinochem Ningbo Latex Gloves Factory | | |
| Date of Submission: | 2 March 1998 | | |
| Device Name: | Latex Finger Cot, Powder-Free, with Protein Labeling | | |
| Proprietary Name: | (Multiple Labels) Latex Finger Cot, Powder-Free, with
Protein Labeling | | |
| Labels/Labeling: | This device will be marketed to healthcare professionals at dentist,
and doctor offices, laboratories, clinics and hospitals through its
intended use. | | |
| Intended Use: | A finger cot is a disposable device intended for
medical purposes that is worn on the examiner's finger
to prevent contamination between patient and examiner. | | |
| Substantial Equivalence: | This device is equivalent to those in commercial distribution. They
are to be worn as a protective device on the examiner's finger. | | |
Both in its intended use and/or physical characteristics, this device is equivalent to devices currently marketed by U.S. companies.
EXHIBIT L
Page 39 of 40
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a caduceus, which is a symbol of medicine and health. The caduceus is made up of three stylized human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1998 MAY
Sinochem Ningbo Latex Gloves Factory C/O Ms. Janna P. Tucker Official Correspondent for Sinochem Ningbo Latex Gloves Factory Ms. Janna Tucker & Associates 19001 South Richfield #185 Green Valley, Arizona 85614
K980827 Re : Latex Finger Cot, Powder-Free, with Protein Trade Name: Content Labeling Claim (50 Micrograms or Less) Regulatory Class: I Product Code: LZB March 2, 1998 Dated: March 3, 1998 Received:
Dear Ms. Tucker:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major -----regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
2
Page 2 - Ms. Tucker
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-20A1 or (301) 443-6597 or at its internet address "http://www.fdajgov/cdrh/dsmamain.html".
Sincerely yours,
Timothy R. Ulatowski
Tim Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
:
.' '. Sinochem Ningbo Latex Gloves Factory APPLICANT: 980827 510(K) NUMBER : LATEX FINGER COT, POWDER-FREE, WITH PROTECTION CONTENT DEVICE NAME: LABELING CLAIM ( 50 MACROGRAMS OR LESS)
A patient examination glove is a disposable device intended for medical purposes that is
t and A patient examination glove is a disposable device incomination 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 Dental, Infection Control, and General Hospital Devices | |
|---|---|
| 510(k) Number | K980827 |
| Prescription Use_ | OR | Over-The-Counter Use_X |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
EXHIBIT B
Page 2 of 40