(35 days)
None
Not Found
No
The 510(k) summary describes a standard medical examination glove and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
No.
The device is a patient examination glove, intended to prevent contamination, not to treat a medical condition.
No
The device description states it is an "examination glove," and its intended use is to prevent contamination, not to diagnose a medical condition.
No
The device is a physical examination glove, not a software application. The description clearly outlines a tangible product made of polymer-coated latex.
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 during a patient examination. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a glove, which is a physical barrier.
- 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 used to perform tests in vitro (outside the body) on samples to gain information about a patient's health status. A patient examination glove is a medical device used in vivo (on the body) as a protective barrier.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purpose and worn on the hand of health care personnel to prevent contamination between health care personnel and the patient.
Product codes
LYY
Device Description
Polymer Coated Powder free latex examination gloves (with a protein label claim 50 MICKOGRAMS OR LESS
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 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
JUL 3 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sharene Wan Ms. Quality Latex Products Malaysia Sdn Bhd 18-20, Jalan Kilang 2 Jelapang Light Industrial Estate Ipoh. Perak, MALAYSIA
Re: K011995 Trade/Device Name: Polymer Coated Latex Medical Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulatory Class: I Product Code: LYY May 28, 2001 Dated: June 26, 2001 Received:
Dear Ms. Wan:
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 regulations 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 Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to
1
Page 2 - Ms. Wan
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 entb response or light on you might have under sections 531 through 542 of the Act for devices under the Electronic chrough Siz or on 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 debtired in your in four alence of your device to a legally rinding or builded device results in a classification for your marketed predicatorermits 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) 594-4692. Additionally, for questions on Compriance at (501) seetising of your device, please contact che promote 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 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/dsma/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
2
K 011995
Attachment 2
INDICATIONS FOR USE
Applicant : Quality Latex Products Malaysia Sdn. Bhd., Quarty Dalan Kilang 2, Jelapang Light Industrial Estate, Taman Pertama, 30100 Ipoh, Perak, Malaysia
Device Name : Polymer Coated Powder free latex examination gloves (with a protein label claim 50 MICKOGRAMS OR LESS
Indications for Use :
A patient examination glove is a disposable device intended for medical purpose and A patient Exammation grovent contamination between health care personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109 ાર
Over-The-Counter
Clair S. Ulm
(Division Sign-Off) Division of Dental, Infection and General Hospital D 510(k) Number