(69 days)
Not Found
Not Found
No
The summary describes a medical glove, which is a passive barrier device, and there is no mention of AI or ML in the provided text.
No
The device, a medical glove, is intended for contamination prevention, not for treating or preventing a disease or condition.
No
Explanation: The device, a medical glove, is intended to prevent contamination between healthcare personnel and patients, not to diagnose any condition.
No
The 510(k) summary describes a medical 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 to prevent contamination between healthcare personnel and the patient by being worn on the hand. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: While "Not Found" is listed, the intended use clearly describes a physical barrier device.
- No Mention of Diagnostic Testing: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition.
- No Mention of Image Processing, AI, DNN, or ML: These are often associated with diagnostic devices that analyze data.
- Input Imaging Modality: Listed as "Not Applicable," further indicating it's not an imaging-based diagnostic.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. A medical glove does not fit this description.
N/A
Intended Use / Indications for Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Product codes
LZA
Device Description
Patient Examination Gloves, Nitrile Powder; Omni Flex Nitrile Examination Glove, Powder Free, Turquoise
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
healthcare 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)
Not Found
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of a human figure with three lines extending from the head, resembling wings or feathers. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 1999
K.C. Choong Vice President of Manufacturing OmniGrace (Thailand) LTD. 641 Moo 5 Kanchanawanit Road Tambon Banpru Hatyai, Songkhla Thailand 90250
Re: K991845 Patient Examination Gloves, Nitrile Powder Trade Name: Free, Turquoise Requlatory Class: I Product Code: LZA May 28, 1999 Dated: Received: May 28, 1999
Dear K.C. Choong:
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 Regulations, Title 21, Parts 800 to 895. ਉ 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 requlation may result in regulatory action.
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Page 2 - K.C. Choong
In addition, FDA may publish further announcements concerning your device in the Federal Register.
this response to your premarket notification Please note: 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 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 one rogen and ification" (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
Timothy A. Ulatowski
Tim ty A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
KANCHANAWANIT ROAD TAMBON BANPRU HATYAI SONGKHLA THAILAND 90250 TEL: (6674) 439 526 FAX: (6674) 210 600
May 1999 Attachment II
OmniGrace (Thailand) Ltd. 510(k) Premarket Notification Patient Examination Glove, Nitrile, Powder- Free, Turquoise
INDICATIONS FOR USE STATEMENT
Applicant : OmniGrace (Thailand) Ltd. 510(k) Number : K 99 1845 Device Name : Omni Flex Nitrile Examination Glove, Powder Free, Turquoise
Indications For Use
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE)
| Prescription Use
| Per 21 CFR 801.109 | |
|---|---|
| OR Over-The-Counter | X |
Chin S. Lin
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | V991845 |
|---|---|
| (5) |