(79 days)
The provided text does not contain any predicate devices with K/DEN numbers. The "Predicate Device(s)" section explicitly states "Not Found".
Currently, the provided text does not contain any K/DEN numbers for Reference Devices.
No
The device is a simple examination glove and the summary explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
A therapeutic device is used to treat or alleviate a medical condition. Examination gloves prevent contamination but do not directly treat a patient's condition.
No
The device, Powder Free Latex Examination Gloves, is described as a disposable device worn for contamination prevention between patient and examiner. Its intended use focuses on protection and hygiene, not on identifying, detecting, or measuring a medical condition or disease, which are characteristics of a diagnostic device.
No
The device is described as "Powder Free Latex Examination Gloves," which are physical hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The description clearly states the device is a "Powder Free Latex Examination Glove" intended to be worn on the hand or finger to prevent contamination. This is a barrier device used for protection, not a test performed on a sample from the body.
The information provided describes a medical device, specifically a personal protective equipment (PPE) item, but it does not fit the definition of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Powder Free Latex Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
Powder Free Latex Examination Gloves
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
medical purposes
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 seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three swooping lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2004
Mr. Lee Son Hong Chief Executive Officer Asia Pacific Latex Sdn. Bhd. Lot 12, Medan Tasek, Tasek Industrial Estate, 31400 Ipoh, Perak Darul Ridzuan, MALAYSIA
Rc: K033530
Trade/Device Name: Asia Pacific Latex Sdn. Bhd. Powder Free Latex Examination Gloves, Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: December 6, 2003 Received: December 18, 2003
Dear Mr. Hong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 adultcration.
If your device is classified (sec above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Nr.), I randy of the Codc of Federal Regulations, Title 21, Parts 800 to 898. In
1
Page 2 - Mr. Hong
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the rece of any vote all the Act's requirements, including, but not limited to: registration 1 od intiles comply wart 807); labeling (21 CFR Part 801); good manufacturing practice and ifoung (21 cert forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as lectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a promative nouted on one 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), n you deente specific at the of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 vours.
Chiu Lin, Ph., D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(K) Number (if known)
K 033530
Powder Free Latex Examination Gloves Powder Free Latex Extraction Clouden Clouden.
The Powder Free Latex Examination Gloves is a disposable The Powder Free Lates, Examination That is worn on the device intended for medical parposer manager management patient and examiner.
Prescription Use (Part 21CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Ko33530
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IE NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pat Anf. Stetson Arnold Chef 1/2/04
Page 1 of
(Division Sign-Off) Division of Anesthesiology. General Hospital, Infection Control, Dental Devices
510(k) Number: K033530