(15 days)
Not Found
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device, a patient examination glove, is intended to prevent contamination, not to treat a disease or condition.
No
The device is described as examination gloves used to prevent contamination, not to diagnose a medical condition.
No
The device description clearly states it is "POWDER FREE LATEX EXAMINATION GLOVES," which are physical hardware devices.
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 the examiner and the patient by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description is for examination gloves, which are a physical barrier device.
- 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 samples
- Providing information for diagnosis, monitoring, or screening
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. Examination gloves do not perform such tests.
N/A
Intended Use / Indications for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and the patient.
Product codes
LYY
Device Description
Not Found
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
examiner
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 & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with its wings spread, suggesting a sense of protection and care.
JUN - 5 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chua Beng Chuan Managing Director U.O.P. Rubber Products Sdn Bhd 878 Jalan Bandar Baru Nibong Tebal Penang. MALAYSIA
Re : K011563 Powder Free Latex Examination Gloves Trade/Device Name: with Water Extractable Protein Labeling Claim ( 50 Micrograms or Less ) Requlation Number: 880.6250 I Regulatory Class: Product Code: LYY Dated: May 5, 2001 May 21, 2001 Received:
Dear Mr. Chuan:
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 legally marketed predicate 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 of the Act. The general controls provisions 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that,
1
Page 2 - Mr. Chuan
through periodic QS inspections, the Food and Drug Chrough periodic go inspectify such assumptions. Failure to Adminisclacion (IMP regulation may result in regulatory In addition, FDA may publish further announcements action. action: In aur device in the Federal Register. Please note: concerning your acvros in area in a submission submission does chirs response to your promobility have under sections 531 not arress and the Act for devices under the Electronic chrough 342 or eno notrol provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as Inis receir will arrew your your market notification. The FDA described in your srown provilence of your device to a legally Finding of subbeaneral oquination in a classification for your marketed predicate awves 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 regaradian (stic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compreason as (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" (21CFR 807.97). Other general information on your responsibilities under the Act may be Information on Journali Manufacturers Assistancers Assistance obtained from che biving (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
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
U.O.P. Rubber Products Sdn.Bhd.
878 Jalan Bandar Baru, 14300 Nibong Tebal, Pulau Pinang, Malaysia. Fax : (04)-5932218 Tel : (04)-5931121, 5931122 Our Ref : CBC/050501/04 Date : 05/05/2001 Your Ref :
ATTACHMENT 2 :
INDICATION FOR USE
Applicant : U.O.P. RUBBER PRODUCTS SDN. BHD.
01 1563 510(k) Number (if known) : _
Device Name : POWDER FREE LATEX EXAMINATION GLOVES. WITH WATER EXTRACTABLE PROTEIN LABELLING CLAI
Page : 1/1
Trade Name : (1) SANI-SAFE (2) Other clients private labeling
Indication For Use :
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The-Counter | X | |
|---|---|---|---|---|
| Per 21 CFR 801.109 |
Qin S. Lim
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K011563 |
|---|---|
| --------------- | --------- |