(90 days)
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, Trade Name : Arsoft OR other client's trade name.
The provided document is an FDA 510(k) clearance letter for Nitrile Examination Gloves and does not contain information about acceptance criteria or a study proving device performance as typically expected for complex medical devices with performance claims (e.g., diagnostic AI tools).
The document is a regulatory approval notice, indicating that the device is substantially equivalent to a legally marketed predicate device. This type of clearance generally relies on demonstrating equivalence in terms of intended use, technological characteristics, and safety and effectiveness, rather than a detailed performance study against specific acceptance criteria.
Therefore, almost all of the requested information cannot be extracted from this document, as it is not a performance study report.
Here's what can be inferred or explicitly stated based on the document's nature:
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A table of acceptance criteria and the reported device performance: Not applicable. The document is an FDA clearance letter, not a performance study report. There are no acceptance criteria or reported device performance metrics in this context. The clearance is based on substantial equivalence.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This document does not describe a performance study with a test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. This document does not describe a performance study with a test set.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This document does not describe a performance study with a test set.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an examination glove, not an AI or diagnostic device that would involve human readers or MRMC studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an examination glove, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a medical glove in the context of substantial equivalence primarily relates to its material properties, physical dimensions, leak resistance, and biocompatibility, which are typically assessed through standardized tests and comparisons to predicate devices, not expert consensus on diagnostic images or pathology.
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The sample size for the training set: Not applicable. This document does not describe a performance study involving a training set for an algorithm.
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How the ground truth for the training set was established: Not applicable. This document does not describe a performance study involving a training set for an algorithm.
In summary: The provided document is an FDA 510(k) clearance letter for medical gloves, indicating substantial equivalence to a predicate device. It does not contain the type of detailed performance study information with acceptance criteria, sample sizes, and expert adjudication that would be requested for an AI/diagnostic device.
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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
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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
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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
§ 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.