(275 days)
Patient examination gloves are "disposable medical devices intended for medical purposes that are worn on the examiner's hand to help prevent contamination between patient and examiner".
Latex Patient examination gloves, Powder Free
This document is a 510(k) clearance letter from the FDA for "Powder-Free, Latex Patient Examination Gloves." It does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria.
The letter simply states that the FDA has reviewed the submission and determined the device is "substantially equivalent" to legally marketed predicate devices. It does not provide:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance, or ground truth establishment.
- Information on expert adjudication, MRMC studies, or standalone algorithm performance.
- Any specifics on the studies conducted to demonstrate the device's performance.
The letter is a regulatory approval, not a scientific study report. Therefore, I cannot fulfill your request with the provided input.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 1997
MD Yusof Bin Ibrahim •PT. Sarana Indoprotex JL. IR. Sutami KM. 07 P.O. Box 214 TNK, Bandar Lampunq 35001 Indonesia
Re : K970773 Powder-Free, Latex Patient Examination Trade Name: Gloves Requlatory Class: I Product Code: LYY Dated: November 21, 1997 November 21, 1997 Received:
Dear Mr. Ibrahim:
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 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. ਰੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does
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Paqe 2 - Mr. Ibrahim
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic enroduct 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 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 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.gov/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 Radiological Health
Enclosure
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510(k) Number (if known): K970773
Device Name: Latex Patient examination gloves, Powder Free
Indications For Use: Patient examination gloves are "disposable medical devices intended for medical purposes that are worn on the examiner's hand to help prevent contamination between patient and examiner".
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qhim Salim
(Division Sign-Off) Division of Dents and General Ho 510(k) Numbe
Prescription Use (Pcr 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 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.