(43 days)
Biopro™, Correct Touch® (Powdered) is a medical glove which is worn on the hand of health care and similar personnel to prevent contamination between patient and the examiner.
Latex Powdered Examination Glove
This document is a marketing clearance letter for Latex Powdered Examination Gloves. As such, it does not contain the detailed technical study information like performance data, ground truth establishment, or sample sizes for AI/algorithm-based devices. The request is for information on a device and its acceptance criteria and the study that proves the device meets the acceptance criteria. This document is a regulatory approval for a physical medical device not a software medical device. The information requested (acceptance criteria, details of a study with sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets) are specific to the validation of software algorithms or AI-based medical devices. This document pertains to traditional physical medical devices.
Therefore, most of the requested information cannot be extracted from this document, as it outlines marketing approval based on substantial equivalence for a physical glove, not a software device's performance study.
Here's what can be stated based on the provided text:
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A table of acceptance criteria and the reported device performance: Not applicable/Not available. This document does not detail specific performance criteria for the latex glove beyond its intended use for preventing contamination. The primary "acceptance criteria" here is substantial equivalence to a legally marketed predicate device, not performance metrics based on a clinical or technical study.
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Sample size used for the test set and the data provenance: Not applicable/Not available. No test set or data provenance details are provided as this is not a software device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not available. No ground truth establishment by experts is described for a latex glove.
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Adjudication method: Not applicable/Not available. No adjudication method is described.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable/Not available. This type of study is for diagnostic software devices.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/Not available. This is not a software algorithm.
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The type of ground truth used: Not applicable/Not available. Ground truth, in the context of AI/software, is not relevant for a physical medical glove. Its approval is based on material properties, manufacturing standards, and substantial equivalence.
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The sample size for the training set: Not applicable/Not available. There is no training set for a physical glove.
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How the ground truth for the training set was established: Not applicable/Not available. There is no training set or ground truth for a physical glove.
What the document does indicate regarding "acceptance":
The device (Latex Powdered Examination Glove) was accepted by the FDA based on substantial equivalence to devices marketed prior to May 28, 1976. This is the primary regulatory "acceptance criteria" for this type of device and submission (510(k)).
The "study that proves the device meets the acceptance criteria" in this context refers to the 510(k) submission itself, which demonstrates substantial equivalence, typically through comparison of physical and chemical properties, intended use, and performance claims (e.g., barrier integrity, biocompatibility) to a predicate device, rather than a clinical performance study with human readers or AI algorithms. The document does not provide the specifics of how that substantial equivalence was demonstrated (e.g., specific test results on barrier integrity, tensile strength, etc.), as it is merely the clearance letter.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract shapes that resemble a person with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2000
Mr. James H. Lale Chief Executive Officer Biopro (M) Sdn. Bhd. Lot 14, PT 4204 Lingkaran Sultan Hishamuddin North Port Industrial Estate 42000 Port Klang, Selangor Darul Ehsan, Malaysia
K994043 Re : Latex Powdered Examination Glove Trade Name: Requlatory Class: I Product Code: LYY Dated: December 15, 1999 December 20, 1999 Received:
Dear Mr. Lale:
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, Drug, 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 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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
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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 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. Ulatowski
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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510(k) Submission - Powdered Latex Examinations Gloves Submitted by Biopro (M) Sdn Bhd (603) 376-1390 Fax (603) 376-1787
3.0 Indications for Use Statement:
Biopro (M) Sdn Bhd
510(k) Number (if known) K994043
Device Name:
Applicant:
Biopro™ Correct Touch or any other private labeling Powdered Latex Examination Gloves
Indications For Use:
Biopro™, Correct Touch® (Powdered) is a medical glove which is worn on the hand of health care and similar personnel to prevent contamination between patient and the examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Devices Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The Counter Use (Optional Format 1-2-96)
Qun S. Lin
Division of Dental, Infection Control. and General Hospital Devices
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OR
§ 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.