(43 days)
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Not Found
No
The summary describes a standard medical glove and contains no mention of AI, ML, or related technologies.
No
The device prevents contamination between the patient and examiner, which is a preventive measure, not a therapeutic treatment for a disease or condition.
No
The device, a medical glove, is intended to prevent contamination, not to diagnose a condition or disease.
No
The device is a physical medical glove, not a software application.
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 patient and examiner by being worn on the hand. This is a barrier function, not a diagnostic function performed on samples taken from the body.
- Device Description: It's described as a "Latex Powdered Examination Glove," which 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
Therefore, the Biopro™, Correct Touch® (Powdered) glove is a medical device, but it falls under the category of a barrier device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
LYY
Device Description
Powdered Latex Examination Gloves
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)
Not Found
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/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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Page 2 - Mr. Lale
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
2
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