BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)

• K Number: K990876
• Device Name: BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)
• Manufacturer: BRIGHTWAY HOLDINGS SDN. BHD.
• Date Cleared: 1999-06-23 ( 99 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Age Range: All
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Brightway™ Brand Colored Nitrile Examination Glove (Powdered) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

Device Description

Brightway™ Brand Colored Nitrile Examination Glove (Powdered)

AI/ML Overview

This is a 510(k) clearance letter for "Brightway™ Brand Blue Nitrile Examination Gloves (Powdered)". As such, it does not contain the detailed study results, acceptance criteria, and performance data typically found in a clinical study report or a pre-market approval (PMA) application.

510(k) clearances are based on a showing of substantial equivalence to a predicate device, rather than a demonstration of clinical efficacy and safety through extensive clinical trials. Therefore, the document will not provide answers to most of your specific questions regarding acceptance criteria, performance metrics, sample sizes, ground truth establishment, or multi-reader studies.

Here's what can be inferred or stated based on the provided document and the nature of 510(k) submissions for this type of device:

1. A table of acceptance criteria and the reported device performance:

   • Not available in this document. For examination gloves, acceptance criteria typically relate to physical properties (e.g., tensile strength, elongation, freedom from holes) and biocompatibility. The performance would be tested against recognized standards (e.g., ASTM standards for medical gloves). This document only states that the device is "substantially equivalent."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not available in this document. Such details would be in the 510(k) summary or full submission, not the clearance letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. This question pertains to diagnostic or analytical devices where expert interpretation of results is crucial for ground truth. For examination gloves, "ground truth" relates to the physical and chemical properties of the material and their performance against established standards, not expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. See point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is an examination glove, not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is an examination glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For examination gloves, the "ground truth" for showing substantial equivalence would typically be:
     • Standardized laboratory testing: Against recognized consensus standards (e.g., ASTM D6319 for Nitrile Examination Gloves) for attributes like freedom from holes (water leak test), tensile strength, elongation, and dimensions.
     • Biocompatibility testing: According to ISO 10993 series (e.g., cytotoxicity, irritation, sensitization).
   • The document itself does not specify these, only implies that the device met the requirements for substantial equivalence.

8. The sample size for the training set:

   • Not applicable and not available. This is not an AI/machine learning device. The concept of a "training set" in this context is irrelevant. For manufacturing quality control, there would be sampling plans, but not a "training set" in the AI sense.

9. How the ground truth for the training set was established:

   • Not applicable. See point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 1999

Mr. G. Baskaran Managing Director Brightway Holdings Sdn. Bhd. Lot 1559, Jalan Istimewa Batu Belah, 42100 Klang Selangor Darul Ehsan MALAYSIA

Re : K990876 Briqhtway™ Brand Blue Nitrile Examination Trade Name: Gloves (Powdered) Requlatory Class: I Product Code: LZA Dated: June 4, 1999 Received: June 8, 1999

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 aqainst 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 Requlations, 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Paqe 2 - Mr. Baskaran

this response to your premarket notification Please note: 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.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fdaygov/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 Radioloqical Health

Enclosure

{2}------------------------------------------------

3.0 Indications for use

.. ..

Applicant	: BRIGHTWAY HOLDINGS SDN. BHD.
510(k) number	: K 990876
Device name	: Brightway™ Brand Colored NitrileExamination Gloves (Powdered)

Indications for use:

Brightway™ Brand Colored Nitrile Examination Glove (Powdered) is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

Qus S. him
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital II 510(k) Number .

Regulation Number and Section

§ 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.