(59 days)
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Not Found
No
The 510(k) summary describes a standard medical glove and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML devices.
No.
The device description and intended use clearly state it is an examination glove, used to prevent contamination, not to treat a condition or restore a function.
No
Explanation: The device is described as an examination glove used to prevent contamination, not to diagnose a condition or disease.
No
The device is described as latex examination gloves, which are a physical 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 clearly states that the gloves are worn on the hand of healthcare personnel to prevent contamination. This is a barrier function, not a diagnostic function performed on samples taken from the body.
- Device Description: The description focuses on the material (Natural Rubber), protein content, and sterility, all of which relate to the physical properties and intended barrier use of the glove.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
BRIGHTWAY™ Brand Latex Examination Gloves (Powdered, sterile) containing 150 ugm or less of water extractable protein per gram is a disposable patient examination glove made of Natural Rubber which is worn on the hand of healthcare and similar personnel to prevent contamination from patient and examiner.
Product codes
LYY
Device Description
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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
healthcare 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)
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Reference Device(s)
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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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2003
Mr. G Baskaran Managing Director Brightway Holdings SDN. BHD. Lot 1559, Jalan Istimewa, Batu Belah, 42100 Klang, Selangor Darul Ehsan MALAYSIA
Re: K032938
Trade/Device Name: Brightway Brand Latex Examination Gloves (Powdered, Sterile) Containing 150 ugm or Less of water Extractable Protein Per Gram Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: September 15, 2003 Received: September 22, 2003
Dear Mr. Baskaran:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -Mr. Baskaran
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Susan Gunn
/Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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3.0 Indications for use
| Applicant
| 510(k) number | : BRIGHTWAY HOLDINGS SDN. BHD. |
|---|---|
| Device name | |
| 1 . 1 . 1 | : BRIGHTWAY™ Brand Latex Examination |
| Gloves (Powdered, Sterile) | |
| Containing 150 ugm or less of water | |
| extractable protein per gram. |
Indications for use:
BRIGHTWAY™ Brand Latex Examination Gloves (Powdered, sterile) containing 150 ugm or less of water extractable protein per gram is a disposable patient examination glove made of Natural Rubber which is worn on the hand of healthcare and similar personnel to prevent contamination from patient and examiner.
Susanna F. Panik
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K032938
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)