(34 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or contamination between patient and finger to prevent examiner.
Powdered Green Latex Examination Gloves
The provided document is an FDA 510(k) clearance letter for "Powdered Green Latex Examination Gloves." This document does not contain any information regarding acceptance criteria, device performance studies, or details about AI-based device evaluations.
The letter is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses general controls, regulations, and contact information for the manufacturer.
Therefore, I cannot answer your request based on the provided text. There is no information in the document about:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts, or adjudication methods for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Type of ground truth or training set details.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 16588
Mr. Lee Aik Lim Managing Director Besglove Medicare Sdn. Bhd. Lot 6, Jalan P/2A, Bangi Industrial Estate, 43650 Bandar Baru Bangi, Selangor Darul Ehsan, MALAYSIA
Re : K982284 Powdered Green Latex Examination Gloves Trade Name: Regulatory Class: I Product Code: LYY Dated: June 22, 1998 Received: June 30, 1998
Dear Mr. Lee Aik Lim:
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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Lee Aik Lim
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4692. 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,
S. Dutnam for
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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Attachment 7
510(k) number(if known): _K982284
Device Name: Powdered Green Latex Examination Gloves
Indications For Use:
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or contamination between patient and finger to prevent examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Qun S. Lin
(Division Sign Off)
Division Sign Off) Division of Dental. Infection Cont and General Hospi 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 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.