(90 days)
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No
The device description and intended use clearly describe a standard medical glove, with no mention of AI/ML capabilities or related technologies like image processing or data analysis.
No
The intended use of the device is to prevent contamination, not to provide therapy or treatment for a condition.
No
Explanation: The device is described as medical gloves, which are used to prevent contamination between healthcare personnel and patients. This is a barrier function, not a diagnostic one. Diagnostic devices are used to identify diseases or conditions.
No
The device description clearly states it is "NITRILE EXAMINATION GLOVES," which are physical hardware.
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: The description is for "NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE". This is 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. Medical gloves, while used in a healthcare setting, do not perform this function.
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
LZA
Device Description
Nitrile Examination Gloves, Non-Sterile, Powder-Free
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand
Indicated Patient Age Range
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Intended User / Care Setting
health care and similar personnel
Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/2 description: The image shows a partial view of a logo or emblem. The visible portion includes the stylized depiction of three human profiles facing to the right, arranged in a stacked formation. To the left of the profiles, there is a curved text that reads "DEPARTMENT OF HEALTH &". The text is oriented vertically, following the curve of the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1998 DEC
Mr. Chua Hooi Koon Managing Director Alliance Rubber Products Sendirian Berhad Lot 2716 & 2720, MK 7, Kawasan Perindustrian Bukit Panchor, 14300 Nibong Tebal, Pulau Pinang, MALAYSIA
Re : K983146 Arsoft, Nitrile Examination Gloves, Non-Trade Name: Sterile, Powder-Free Blue Regulatory Class: I Product Code: LZA October 24, 1998 Dated: Received: November 5, 1998
Dear Mr. Chua Hooi 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 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 The general controls controls provisions of the Act. 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. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical 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 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 not affect any obligation you might have under sections 531
1
Paqe 2 - Mr. Chua Hooi Koon:
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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
premarket notification" (21CFR 807.97). Other genera Other qeneral 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
y A. Ulatowski 11 i mo Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo for Alliance Rubber Products Sdn.Bhd. The logo consists of a stylized graphic to the left of the company name. The company name is written in a serif font. The graphic is a black, abstract design.
Lot 2716 & 2720, MK 7, Kawasan Perindustrian Bukit Panchor, 14300 Nibong Tebal, Company No. : 52446-U Pulau Pinang, Malaysia. Fax : (04)-5932262, 3322034 E-mail : allianc@po.jaring.my Tel : (04)-5932235, 5937616 Our Ref : CHK/150898/04 Date : 15-08-98 Page : 1/1 Your Ref :
ATTACHMENT 2 :
INDICATION FOR USE
Applicant : ALLIANCE RUBBER PRODUCTS SDN. BHD.
510(k) Number (if known) : _ K 98 31 4 6
Device Name : NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE,
Trade Name : Arsoft OR other client's trade name.
Indication For Usc :
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)
Chun S. Lin
(Division Sign-Off)
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devic
510(k) Number K983146
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter
er-The-Counter