(18 days)
Not Found
Not Found
No
The device is a disposable examination glove and the summary contains no mention of AI or ML.
No
The device, examination gloves, is intended to prevent contamination, not to treat a disease or condition.
No
Explanation: The device is described as a "disposable patient examination glove" worn on the hand to prevent contamination. This function is for barrier protection, not for diagnosing medical conditions.
No
The device is described as "Colored Powder Free Nitrile Examination Gloves," which are physical hardware. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on the hand of healthcare personnel to prevent contamination. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an examination glove.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
- No Mention of IVD-Related Information: The document lacks any information typically associated with IVDs, such as performance metrics like sensitivity, specificity, or details about analytical or clinical validation.
Therefore, the Brightway TM Brand Colored Powder Free Nitrile Examination Gloves (Orange) are a medical device, but they fall under the category of a barrier device for infection control, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Brightway TM Brand Colored Powder Free Nitrile Examination Gloves (Orange) ia a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination from patient and examiner.
Product codes
LZA
Device Description
Brightway TM Brand Colored Powder Free Nitrile Examination Gloves (Orange) ia a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination from patient and examiner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare and similar personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, resembling a symbol or abstract representation of a person.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2002
Mr. G. Baskaran Managing Director Brightway Holdings Sdn. Bhd. Lot 1559, Jalan Istimewa Batu Belah, 42100 Klang, Selangor Darul Ehsan, MALAYSIA
Re: K022878
Trade/Device Name: Brightway Brand Colored Powder Free Nitrile Examination Gloves, Orange Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: August 23, 2002 Received: August 30, 2002
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.
1
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 (QS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Tim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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? " Indication for use
| Applicant | : BRIGHTWAY HOLDINGS SDN. BHD |
|---|---|
| 510(K) No | : K022878 |
| Device Name | : Brighway TM Brand Colored Powder Free |
| Nitrile Examination Gloves (Orange) |
Indication for use
Brightway TM Brand Colored Powder Free Nitrile Examination Gloves (Orange) ia a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination from patient and examiner.
Qiu Si Lin
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K022828