(29 days)
Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs (Blue) is a disposable device intended for Medical Purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This davice also provides protection against exposure to certain chemotherapy drugs.
Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs (Blue)
The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (Blue)". It does not contain information about acceptance criteria or a study proving the device meets said criteria.
Instead, the letter establishes that the device is "substantially equivalent" to legally marketed predicate devices and therefore can be marketed, subject to general controls. It also outlines regulatory requirements, but it does not detail any specific performance acceptance criteria or a study report.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the document.
- Sample sized used for the test set and the data provenance: This information is not present in the document because no specific study results are detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the document.
- Adjudication method: This information is not present in the document.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present in the document.
- If a standalone performance (algorithm only) study was done: This information is not present in the document, as it pertains to a physical medical device (gloves), not an algorithm.
- The type of ground truth used: This information is not present in the document.
- The sample size for the training set: This information is not present in the document.
- How the ground truth for the training set was established: This information is not present in the document.
The document primarily focuses on the regulatory clearance process for a medical device (nitrile examination gloves) and its "Indications for Use," which states: "Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs (Blue) is a disposable device intended for Medical Purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs."
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and health. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2005 APR 7
Mr. Foo Khon Pu Managing Director SMART GLOVE CORPORATION SDN.BHD Lot 6487 Batu 5 ¾, Sementa Jalan Kapar, 42100 Klang Selangor Darul Ehsan MALAYSIA
Re: K050598
Trade/Device Name: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (Blue) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: March 28, 2005 Received: March 30, 2005
Dear Mr. Pu
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becasin 910(4) the device is substantially equivalent (for the referenced above and have determined to tegally marketed predicate devices marketed in intercations for use stated in the environment date of the Medical Device interstate comments, or to truy 20, 1978, and essified in accordance with the forcements of Amendinens, of to devrees that have one in the equire approval of a premarket the Federal Food, Drug, and Cosment of therefore, market the device, subject to the general approval application (1 Mrx). - Fou ney, controls provisions of the Act include controls provisions of the Fred. "The gentles, good manufacturing practice, requirements for annual reagainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into examines. Existing major regulations affecting (PMA), if may be subject to such additional connections, Title 21, Parts 800 to 898. In the Colors your device can oc found in the Couce of Prescents one reach one ming your device in the Federal Register.
{1}------------------------------------------------
Page 2 – Mr. Pu
Please be advised that FDA's issuance of a substantial equivalence determination does not I loase be advisod that 1 Dr. I termination that your device complies with other requirements Incan that 1 277 has made a actestians administered by other Federal agencies. 01 the Act of ally I ederal backed and equirements, including, but not limited to: registration r ou must comply with and 07); labeling (21 CFR Part 801); good manufacturing practice and ilsung (21 CFR Part 807), and ity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the qt 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) This letter wifi anow you to of substantial equivalence of your device to a premaired 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), If you desire spoolite at too mpliance at (240) 276-___ Also, please note the regulation picase contact the Office or Octine to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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/industry/support/index.html.
Sincerely yours,
Suerte Michino Oms
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): K020598
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE Device Name: WITH CHEMOTHERAPY DRUGS (BLUE)
Indications For Use:
Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs (Blue) is a disposable device intended for Medical Purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This davice also provides protection against exposure to certain chemotherapy drugs.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ X___ (21 CFR 801 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shiela N. Murphy, LC 4/7/05
Jivision Sign-Off) Division of Ananthonin's v. General Hospital, Infection Control, Des
Page 1 of
2(k) Number: K050598
§ 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.