(70 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI, ML, or related technologies.
No.
The device is a glove for preventing contamination, not for treating any medical condition.
No
Explanation: The device, Nitrile Exam Gloves, is described as preventing contamination between patient and examiner and is used for medical purposes, but it does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a physical product (Nitrile Exam Gloves) and the performance studies relate to physical properties and biocompatibility, not software performance.
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 during physical examination, not a device used to examine specimens in vitro (outside the body).
- Device Description: "Nitrile Exam Gloves" further reinforces the nature of the device as a physical barrier.
- Lack of IVD Indicators: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
- Performance Studies: The performance studies listed (ASTM standards, water leak test, biocompatibility) are relevant to the physical properties and safety of a glove, not the analytical performance of an IVD.
IVDs are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This glove does not perform such a function.
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
LZA
Device Description
Nitrile Exam Gloves, Powder-Free, 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/tests:
ASTM D 3578-95
ASTM D 5151
FDA Water Leak Test (before & after aging)
Bio-Compatibility
Dermal Sensitization
Primary Skin Irritation
Bio-Burden (bacteria/mold)
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
Image /page/0/Picture/0 description: The image shows the logo for Janna Tucker & Associates. The logo features a stylized Kokopelli figure on the left. The text "JANNA TUCKER & ASSOCIATES" is written in a bold, sans-serif font to the right of the figure.
FEB 2 5 1998
510(k) SUMMARY
19001 S. Richfield #185 Green Valley, AZ 85614 Telephone: (520) 625-2904 Fax: (520) 625-13908
Submitted Bv:
Janna Tucker & Associates 19001 S. Richfield #185 Green Valley, AZ 85614 520-625-2904 Phone: FAX: 520-625-3908
Contact Person: Janna P. Tucker, Official Correspondent for Sinochem Ningbo Latex Glove Factory
Date of Submission: 16 December 1997
Device Name: Nitrile Exam Gloves, Powder-Free, White
Proprietary Name: (Multiple Labels) Nitrile Exam Glove, Powder Free
Labels/Labeling: This device will be marketed to healthcare professionals at dentist. and doctor offices, laboratories, clinics and hospitals through its intended use.
A patient examination glove is a disposable device intended for Intended Use: 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 Influx Pacific SDN. BHD. K970216 for a Nitrile Exam Glove, Powdered,
EXHIBIT M
Page 33 of 34
1
Test Results (Means and/or Results):
This device has met or exceeded the following standards/tests:
ASTM D 3578-95 ASTM D 5151 FDA Water Leak Test (before & after aging) Bio-Compatibility Dermal Sensitization Primary Skin Irritation Bio-Burden (bacteria/mold)
Conclusions:
This device is substantially equivalent to the Influx Pacific SDN. BHD. device approved under K970216.
EXHIBIT M
Page 34 of 34
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EEB 2 5 1998
Ms. Janna P. Tucker Official Correspondent Sinochem Ningbo Latex Gloves Factory C/O Janna Tucker Associates 19001 S. Richfield #185 Green Valley, Arizona 85614
K974710 Re : Nitrile Exam Glove, Powder-Free/White Trade Name: Regulatory Class: I Product Code: LZA Dated: January 19, 1998 Received: January 26, 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 The general controls provisions of the Act 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 (Premarket Approval), it may Existing major be subject to such additional controls. regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಡಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
3
Page 2 - Ms. Tucker
through 542 of 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricia Crassitoffer
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
INDICATIONS FOR USE
| APPLICANT: | Sinochem Ningbo Latex Glove Factory |
|---|---|
| 510(K) NUMBER: | K974710 |
| DEVICE NAME: | Nitrile Exam Glove, Powder-Free |
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)
Chùm S. Lim
(Division Sign-Off)
Division of Dental, Infection Control,
510(k) Nu
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
EXHIBIT B
Page 2 of 34.