(29 days)
A 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
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (less than 50 ug/g per glove)
I am sorry, but the provided text is a Food and Drug Administration (FDA) clearance letter for a medical device, specifically "Polymer Coated, Powder-Free Latex Examination Gloves with Protein Labeling."
This document does not contain the information required to answer your request about acceptance criteria and a study proving device performance.
The letter focuses on:
- Confirming that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device.
- Outlining regulatory requirements and general controls provisions.
- Providing contact information for further guidance.
- Stating the intended use of the gloves.
There is no mention of:
- Specific acceptance criteria for performance.
- Any study data, sample sizes, data provenance.
- Expert involvement for ground truth, adjudication methods.
- Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- Training set details.
Therefore, I cannot generate the requested table or answer the specific questions based on the provided input.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird with outstretched wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2004
Shun Thai Rubber Gloves Industry Public Company, Limited C/O Ms. Janna P. Tucker Official Correspondent Tucker & Associates 198 Avenue De La D' Emerald Sparks, Nevada 89434-9550
Re: K040408
Trade/Device Name: Polymer Coated, Powder-Free Latex Examination Gloves with Protein Labeling (Less Than 50 Ug/Per Glove) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: February 5, 2004 Received: February 17, 2004
Dear Ms. Tucker:
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 - Ms. Tucker
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. 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 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,
for Venkatesh
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
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INDICATIONS FOR USE
| APPLICANT: | SHUN THAI RUBBER GLOVESINDUSTRY PUBLIC COMPANYLIMITED |
|---|---|
| 510(k) NUMBER: | K040408 |
| DEVICE NAME: | POLYMER COATED, POWDER-FREELATEX EXAMINATION GLOVESWITH PROTEIN LABELING (less than50 ug/g per glove) |
A 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
Martha T. O. Lira
(Division Sign-Off) for Dr. Fen
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number K040408
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Martha T. O'Lone
INCB Interim Branch Chief
§ 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.