(56 days)
Not Found
Not Found
No
The device is a simple medical glove and the summary contains no mention of AI or ML.
No
The device, a medical glove, is intended to prevent contamination between healthcare personnel and patients, not to treat a medical condition or disease.
No
Explanation: The device description states "NITRILE EXAMINATION GLOVES", and its intended use is to "prevent contamination between health care personnel and the patient". This indicates a barrier device, not one used for diagnosis.
No
The device description clearly states it is "NITRILE EXAMINATION GLOVES," which are physical hardware.
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 healthcare personnel and the patient by being worn on the hand. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description is for "NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED." This is a physical product used for protection.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening
IVDs are used to perform tests in vitro (outside the body) on samples to provide diagnostic information. Medical gloves are a physical barrier used in vivo (on the body) for protection.
N/A
Intended Use / Indications for Use
A medical gloves is 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
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED.
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
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 shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three parallel lines instead of a single staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 1998
Mr. Chua Hooi Koon Manaqing Director Alliance Rubber Products Sendirian Berhad 878, Jalan Bandar Baru, Sungei Kecil, 14300 Nibong Tebal, Pulau Pinang, MALAYSIA
Re : K980589 ARsafe Nitrile Examination Gloves, Powdered, Trade Name: Non-sterile Regulatory Class: I Product Code: LZA Dated: March 18, 1998 Received: April 9, 1998 --
Dear Mr. Chua Hooi Koon:
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 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your
1
Page 2 - Mr. Chua Hooi Koon
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)-638-2041 or (301) 443-6597 or at its internet address "http://www.fdag.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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/6
Alliance Rubber Products Sdn.Bhd.
878, Jalan Bandar Baru, Sungei Kecil, 14300 Nibong Tebal, Pulau Pinang, Malaysia. Fax : (04)-5932262, 3322034 ( ompany No. : 52446-U Tel : (04)-5932235, 5937616
Page :1/1 Date : 18-03-98 Your Ref : Our Ref :CHK/180398/5
ATTACHMENT 2 :
INDICATION FOR USE
Applicant : ALLIANCE RUBBER PRODUCTS SDN. BHD.
510(k) Number (if known) :
Device Name : NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED.
Trade Name : ARsafe or other client's trade name.
Indication For Use : ........ . ... ........ . . .
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K980589 |
0
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter X