(65 days)
A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infections materials and other contaminants.
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTENCED OD IMER CORTED LATEX EXAMINA HON GLOVES
Here's an analysis of the provided text regarding the acceptance criteria and study for the device:
The provided text is a 510(k) premarket notification letter from the FDA to KL Kepong Rubber Products Sdn Bhd, concerning "Powder Free Polymer Coated (Acrylic Based) Latex Patient Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)."
This document does not contain the specific information required to complete your request. It is an FDA clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices, meaning it doesn't need a Premarket Approval (PMA) application. This letter does not include details about device performance, acceptance criteria, or specific studies conducted to prove the device meets performance criteria.
Therefore, I cannot provide the requested information from the given text.
To elaborate on why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: This letter only states the device is "substantially equivalent" to predicate devices. It doesn't list specific performance metrics or their acceptance thresholds.
- Sample sized used for the test set and the data provenance: There is no mention of any test set size or where the data came from.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment and expert details are not part of this type of regulatory clearance letter.
- Adjudication method: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: MRMC studies are typically for diagnostic devices or AI algorithms where reader performance is a key metric. This is a physical glove, so an MRMC study would not be applicable in this context.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This pertains to AI algorithms, which is not what this device is.
- The type of ground truth used: Not mentioned, and generally not applicable for a physical barrier device like a glove in this context.
- The sample size for the training set: This refers to AI algorithms; not applicable here.
- How the ground truth for the training set was established: This refers to AI algorithms; not applicable here.
In summary, the provided document is a regulatory approval letter and does not contain the detailed study results or acceptance criteria you're looking for. Such information would typically be found in the 510(k) submission itself (the "premarket notification") rather than the FDA's response letter.
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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 stylized image of an eagle with three heads, all facing to the right. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top and left side of the circle.
JAN 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
·Ms. Yim Hoon Pung General Manager KL Kepong Rubber Products Sdn Bhd. Ladang Pinji, Bahagian Sengat, 31300 Kampung Kepayang, Ipoh, Perak Darul Ridzuan, MALAYSIA
Re: K023866
Trade/Device Name: Powder Free Polymer Coated (Acrylic Based) Latex Patient Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less) Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: November 19, 2002 Received: November 20, 2002
Dear Mr. Pung:
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. Pung
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), 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) you may obtain. 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,
Susa Russo
Timothy A. Ulatowski 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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3.0 INDICATIONS FOR USE STATEMENT :
APPLICANT : KL KEPONG RUBBER PRODUCTS SDN. BHD.
| 510(K) | KO23866 |
|---|---|
| -------- | --------- |
DEVICE NAME POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTENCED OD IMER CORTED LATEX EXAMINA HON GLOVES
N FOR USE INDICATION FOR USE .
A powder-free patient examination glove is a disposable device
made of natural rubber latex or synthetic material that may bear a
trace amount of glove powder and is intended to be worn on the
hand or finger(s) for medical purposes to provide a barrier against
potentially infections materials and other contaminants.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clain Schim
Gener
510(k) Number: K023866
§ 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.