(46 days)
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No
The 510(k) summary describes a standard examination glove and contains no mention of AI, ML, or any related technologies.
No
The device is described as a "disposable patient examination glove" worn to "prevent contamination," which indicates it is a barrier device for examination purposes, not a therapeutic intervention.
No
Explanation: The "Intended Use / Indications for Use" states that the device is a "disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner." This describes a protective barrier, not a device used to diagnose a medical condition.
No
The device description clearly states it is a physical product (gloves) and does not mention any software components.
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 test performed on samples taken from the body.
- Device Description: The description focuses on the physical characteristics of the glove (polymer coated latex, powder-free, protein content). It doesn't mention any reagents, assays, or analytical components typically found in IVDs.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting substances, or providing diagnostic information.
IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
BrightwayTM Brand Polymer Coated Latex Examination Glov Powder Free containing 50 micro grams or less of water extractab protein per gram is a disposable patient examination glove which worn on the hand of healthcare and similar personnel to prever contamination between 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 is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an emblem that appears to be an abstract representation of an eagle or other bird, with three stylized lines forming the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ਰ APR
Mr. G. Baskaran Managing Director Brightway Holdings Sdn. Bhd. Lot 1559, Jalan Istimewa, Batu Belah, 42100 Klang, Selangor Darul Ehsan MALAYSIA
Re : K990543 Brightway™ Brand Polymer Coated Latex Trade Name: Examination Glove Powder-Free (Contains 50 Mcgm or Less of Water Extractable Protein Per Gram) Regulatory Class: I Product Code: LYY Dated: February 16, 1999 February 22, 1999 Received:
Dear Mr. Baskaran:
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. ਜੋ 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 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.
1
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 requlation 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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REVISED LABELING : 22td MARCH 1999 : K 990543 510 (K) NO. POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE containing 50 ugm or less of water extractable protein per gram
3.0 Indications for use
| Applicant | : BRIGHTWAY HOLDINGS SDN. BHD. |
|---|---|
| 510(k) number | : K 990543 |
| Device name | : BrightwayTM Brand . Polymer Coated La |
| Examination Gloves, Powder Free containing | |
| µgm or less of water extractable protein per gram. |
Indications for use:
BrightwayTM Brand Polymer Coated Latex Examination Glov Powder Free containing 50 micro grams or less of water extractab protein per gram is a disposable patient examination glove which worn on the hand of healthcare and similar personnel to prever contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clim S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital, Intection
510(k) Number K990543
Prescription Use (Per 21 CFR 801.109)
1 24 2017
OR
Over-The-Counter Use X
(Optional Format 1-2-96)
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