(34 days)
Not Found
Not Found
No
The device description and intended use clearly define a standard examination glove, with no mention of AI/ML or related technologies.
No.
The device, a patient examination glove, prevents contamination between patient and examiner but does not treat any medical condition.
No
The device, a patient examination glove, is intended for preventing contamination between patient and examiner, not for diagnosing medical conditions.
No
The device description clearly states it is a "Powdered Nitrile Examination Glove," which is a physical hardware device. There is no mention of software as the primary or sole component.
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 hand or finger to prevent contamination. This is a physical barrier device used during patient examination.
- 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 treatment decisions based on in vitro analysis.
IVDs are devices used to examine specimens taken from the human body to provide information about a person's health. A glove is a physical barrier and does not perform this 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 Patient Examination Glove, Powdere (NATURAL COLOR)
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
Not Found
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 Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1993 JUN
Mr. Tan Kong Chang Executive Director PERUSAHAAN GETAH ASAS SDN. BHD. Lot. 754, Jalan Haji Sirat, Off Jalan Kapar, 42100 Klanq, P.O. Box 188, 41720 Klang, Selangor, Darul Ehsan, MALAYSIA
Re : K991511 Trade Name: Powdered Nitrile Examination Glove, White (Non-Colored) Requlatory Class: I Product Code: LZA Dated: April 27, 1999 Received: April 30, 1999
Dear Mr. Chang:
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.
1
Page 2 - Mr. Chang
In addition, FDA may publish further announcements concerning your device in the Federal Register.
this response to your premarket notification Please note: Flease note: "Chip reflect any obligation you might have under sections 531 through 542 of the Act for devices under the Scettons 301 chrough tontrol provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as first receir will as 10 (k) premarket notification. The FDA acboing of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marice 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 regaracion (stic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact che Dffice of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regaration" (21 CFR 807.97). Other general premation 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,
Timothy A. Ulatowski
Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
Section 3
510 (K) Number (if known) : K99 151
Device Name
: Nitrile Patient Examination Glove, Powdere (NATURAL COLOR)
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ( Per 21 CFR 801. 109 ) OR
Over-The-Counter Use
( Optional Format 1-2-96 )
Qun S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hosp 510(k) Numbe
Page 1 of 1