(48 days)
Not Found
Not Found
No
The summary describes a standard medical glove with no mention of AI/ML capabilities or related technical details.
No.
The device is described as a medical glove for preventing contamination, not for treating a disease or condition.
No
Explanation: The device is described as a "medical glove" worn to prevent contamination. Its intended use does not involve diagnosing any medical condition, disease, or injury.
No
The device description clearly states it is a "Powder-Free Nitrile Examination Glove," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a medical glove worn on the hand to prevent contamination. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description is of a physical glove made of nitrile.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This glove does not perform such a function.
N/A
Intended Use / Indications for Use
As a medical glove, worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Product codes
LZA
Device Description
Powder-Free Nitrile Examination Glove, Blue or White (non-colored)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care and similar personnel
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and three curved lines extending from the bottom of the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 29 1997
Absolute Synthetic Technologies Malaysia Sdn. Bhd. C/O Mr. Tom Bowman Project Chemist Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
K972195 Re : Powder-Free Nitrile Examination Glove, Blue Trade Name: Or White (Non-Colored) Regulatory Class: 工 LZA Product Code: Dated: July 14, 1997 Received: July 16, 1997
Dear Mr. Bowman:
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 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. A 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:
1
Page 2 - Mr. Bowman
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 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,
Patrici Cucentiffor
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
Absolute Synthetic Technologies Malaysia Sdn. Bhd. Applicant:
510(k) Number:
Device Name: Powder-Free Nitrile Examination Glove, Blue or White (non-colored)
Indications for Use:
As a medical glove, worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
| (Division Sign-Off) | Patara Canti |
|---|---|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K972195 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Over-The-Counter______________________________________________________________________________________________________________________________________________________________