(63 days)
Not Found
Not Found
No
The summary describes a standard medical examination glove and contains no mention of AI, ML, or related technologies.
No
Explanation: The device is a patient examination glove, intended to prevent contamination, not to treat a condition or disease.
No
Explanation: The device is described as an examination glove intended to prevent contamination, not to diagnose a medical condition.
No
The device description clearly states it is a "Latex examination 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. This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description is for a physical barrier device (gloves).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purpose and similiar personnel to prevent contamination between health care personnel and the patient.
Product codes
LYY
Device Description
Latex examination gloves (with a protein label claim), Peccaler of Contamp 170 mili grams on 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
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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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 1999
Ms. Sharene Wan Quality Latex Products Malaysia Sdn. Bhd. 18-20, Jalan Kilang 2 Jelapang Light Industrial Estate Taman Pertama 30100 Ipoh, Perak, Malaysia
Re : K993271 Trade Name: Quality Latex Powdered Examination Gloves with Protein Labeling Claim of 170 micrograms or less Regulatory Class: I Product Code: LYY Dated: November 5, 1999 Received: November 9, 1999
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 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, Druq, 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 reqistration, 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Ms. Wan
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 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 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 the regaracion chercless, ":125Panang in 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,
Patricio Cucurella / kk
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
QUALITY LATEX PRODUCTS MALAYSIA SDN. BHD. (59087-U)
Factory 1) 19, Persiaran Kilang, Jelapang Light Industrial Estate, Taman Pertama, 30100 Ipoh. Perak. Malaysia. Tel: 605-5263868 Fax: 605-5263268
- Factory 2) 18 & 20, Jalan Kilang 2, Jelapang Light Industrial Estate, Taman Pertama, 30100 Ipoh. Perak. Malaysia. Tel: 605-5277228 Fax: 605-5277868
Kg9327i
Attachment 2
INDICATIONS FOR USE
Applicant : Quality Latex Products Malaysia Sdn. Bhd., 18-20, Jalan Kilang 2, Jelapang Light Industrial Estate, Taman Pertama, 30100 Ipoh, Perak, Malaysia
Device Name : Latex examination gloves (with a protein label claim), Peccaler of Contamp 170 mili grams on less Indications for Use :
A patient examination glove is a disposable device intended for medical purpose and similiar personnel to prevent 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 OR
Over-The-Conter X
Ction S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number _