(253 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hand or finger to prevent contamination between patient and examiner.
NITRILE EXAMINATION GLOVES ( POWDERED
The provided text is related to a 510(k) clearance letter from the FDA for "Nitrile Powdered Examination Gloves." It does not contain any information about acceptance criteria, device performance studies, or AI/software analysis.
Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for the device, as none of this information is present in the provided document.
The document primarily focuses on the FDA's determination of substantial equivalence for the nitrile gloves to predicate devices and outlines regulatory responsibilities.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Gan Soong Tee Managing Director Influx Pacific Sdn. Bhd. Lot 61, Jalan Usaha 9 Air Keroh Industrial Estate Malacca, West Malaysia
SEP 26 1997
Re: K970216 Nitrile Powdered Examination Gloves Trade Name: Regulatory Class: I Product Code: LZA Dated: September 9, 1997 September 11, 1997 Received:
Dear Mr. Soong Tee:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marice 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 against 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 regulations 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does
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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 requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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 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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours;
Timothy A. Ulatowski
Time Ulatowski W A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Applicant:
INFLUX PACIFIC SDN BHD
510(k) Number (if known):
Device Name:
NITRILE EXAMINATION GLOVES ( POWDERE D
Indications For Use:
A patient examination glove is a disposable device intended for medical purposes that is A parent examiner's hand or linger to a migreat contamination between patient and exominer.
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Concurrence of CDRH Office of Device Evaluation (ODE)
Olin S. Lihn
(Division Sign-O Division of Dental, and General Ha 5 1 O(k) Numbe
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter X
(Optional Pormal 1-2-96)
§ 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.