(23 days)
Not Found
No
The summary describes a standard medical glove and contains no mention of AI or ML technology.
No
The device, a patient examination glove, is intended to prevent contamination, not to treat or cure a disease or condition.
No
A patient examination glove is intended to prevent contamination between patient and examiner, not to diagnose a medical condition.
No
The device description clearly states it is a physical product (Nitrile Exam Gloves) and the performance studies refer to physical tests (ASTM standards, water leak test, bio-compatibility). There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove...worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination, not a device used to examine specimens from the human body to provide diagnostic information.
- Device Description: The description "Nitrile Exam Gloves, Powder-Free, Blue" further reinforces that this is a physical barrier device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or analytical methods
Therefore, this device falls under the category of a medical device used for protection and hygiene, not an in vitro diagnostic device.
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 (comma separated list FDA assigned to the subject device)
LZA
Device Description
Nitrile Exam Gloves, Powder-Free, Blue
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
This device has met or exceeded the following standards/tests: ASTM D 3578-95 ASTM D 5151FDA Water Leak Test (before & after aging) Nitrile Glove Draft ASTM, Sept 97. Bio-Compatibility Dermal Sensitization Primary Skin Irritation Bio-Burden (bacteria/mold)
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.
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
Image /page/0/Picture/0 description: The image shows the logo for Janna Tucker & Associates. The logo features a stylized figure of a Kokopelli, a fertility deity often depicted as a humpbacked flute player. The text "JANNA TUCKER & ASSOCIATES" is written in bold, sans-serif font to the right of the Kokopelli figure.
MAR 2 5 1998
19001 S. Richfield #185 Green Valley, AZ 85614 Telephone: (520) 625-2904 Fax: (520) 625-3908
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: | 27 February 1998 |
| Device Name: | Nitrile Exam Gloves, Powder-Free, Blue |
| Proprietary Name: | (Multiple Labels) Nitrile Exam Glove, Powder Free, Blue |
| 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 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:
This device is equivalent to those in commercial distribution. They are to be worn as a protective device on the examiner's hand or finger.
Both in its intended use and/or physical characteristics, this device is equivalent to devices currently marketed by U.S. companies. It is substantially equivalent to the device manufactured by Sinochem Ningbo Latex Gloves Factory for a Nitrile Exam Glove, Powder-Free, White K974710.
EXHIBIT M
Page 33 of 34
1
Test Results (Means This device has met or exceeded the following and/or Results): standards/tests: ASTM D 3578-95 ASTM D 5151FDA Water Leak Test (before & after aging) Nitrile Glove Draft ASTM, Sept 97. Bio-Compatibility Dermal Sensitization Primary Skin Irritation Bio-Burden (bacteria/mold) This device is substantially equivalent to the Sinochem Ningbo Conclusions: Latex Gloves Factory device approved under K974710.
EXHIBIT M
Page 34 of 34
2
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 stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 25 1998
Sinochem Ningbo Latex Glove Factory C/O Ms. Janna P. Tucker Official Correspondent for Sinochem Ningbo Latex Glove Factory Janna Tucker & Associates 19001 South Richfield #185 Green Valley, Arizona 85614
Re : K980802 Nitrile Exam Glove, Powder-Free, Blue Trade Name: Requlatory Class: I Product Code: LZA Dated: February 27, 1998 Received: March 2, 1998
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 of the Act. The general controls provisions of the Act include reguirements 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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
3
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 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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Whittier
Timothy A. Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
Sinochem Ningbo Latex Gloves Factory
510(K) NUMBER:
K9Y80802
DEVICE NAME:
Nitrile Exam Glove, Powder-Free, Blue
A patient examination glove is a disposable device intended for medical purposes that is I I parvate causiner'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 Dental, Infection Control,
and General Hospital Devices
510(k) Number K980802
Prescription Use_**_
(Per 21 CFR 801.109)
OR
Over-The-Counter Use✗
(Optional Format 1-2-96)
EXHIBIT B
PAGE 2 of 34