(130 days)
Not Found
Not Found
No
The summary describes a medical glove, which is a simple barrier device, and contains no mention of AI, ML, or related concepts like image processing or performance studies typically associated with AI/ML devices.
No
Explanation: The device, a medical glove, is intended to prevent contamination, not to diagnose, treat, or alleviate a disease or condition.
No
Explanation: The device is described as "medical gloves... to prevent contamination," which indicates it is a barrier device for protection, not for diagnosing medical conditions.
No
The device is described as a "medical gloves," which is a physical hardware product, 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 physical 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 (gloves).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Medical gloves do not fit this description.
N/A
Intended Use / Indications for Use
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel 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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chua Hooi Koon Alliance Rubbert Products Sdn. Bhd. 878 Jalan Bandar Baru, Sungei Kecil 14300 Nibonq Tebal Pulau Pinanq, MALAYSIA
AUG - 8 1997
K971183 Re: Trade Name: Gold Finger Latex Patient Examination Gloves, Powder-Free with water extractable protein labeling claim Requlatory Class: I Product Code: LYY Dated: July 14, 1997 Received: July 16, 1997
Dear Mr. Koon:
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 registration, listing of devices, good manufacturing practice, labeling, and prchibitions 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 requirement, as set forth in the Quality System Regulation (QS) for Medical
1
General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 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) 594-4618. 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 premarket notification" (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. Wlatowski
ly A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Alliance Rubber Products Sdn.Bhd.
878, Jalan Bar dar Baru, Sungei Kecil, 14300 Nibong Tebal, Pulau Pinang, Malaysia. Tel : (04)-5932235, 5937616 Fax : (04)-5932262, 3322034 Company No. : 52446-U
Your Ref : Date : 13-03-97 Page :1/1 Our Ref :CHK/130397/5
ATTACHMENT 2 :
INDICATION FOR USE
Applicant : ALLIANCE RUBBER PRODUCTS SDN. BHD.
510(k) Number (if known) :
Device Name : LATEX EXAMINATION GLOVES, POWDER FREE U Profess labeling
Trade Name : (1) GOLD FINGERS (2) FOODHANDLER (3) Other clients private labelling
Indication For Use :
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE)
CO Concurrence
Division of Dantat, Internommen,
nd Gener 5 : Olk) Number
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter