(74 days)
Synthetic Vinyl Medical Examination Powdered Gloves are worn on the hands of Health care and similar personnel to prevent contamination between health care personnel and the patient.
SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES
The provided FDA 510(k) clearance letter (K993664) for "Synthetic Vinyl Medical Examination Powdered Gloves" does not contain information about acceptance criteria or a study demonstrating the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, etc., which are typically associated with diagnostic or AI-powered devices.
Instead, this document is a clearance letter for a Class I medical device (gloves) and pertains to its substantial equivalence to a predicate device already on the market. For such devices, the primary "acceptance criteria" are related to manufacturing quality, safety (e.g., biocompatibility, freedom from harmful substances), and performance standards applicable to gloves (e.g., barrier integrity, tensile strength), rather than detailed clinical performance metrics.
The letter explicitly states: "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."
Therefore, I cannot provide the requested information as it is not present in the provided document. The 510(k) process for this type of device focuses on demonstrating equivalence to a legally marketed predicate, rather than an extensive clinical study with performance metrics in the way your prompt describes for AI or diagnostic devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
'JAN 1 1 2000
Mr. Loo Sun Nooi Assistant QA Manager Top Glove Sdn. Bhd. Lot 4968 Jalan Teratai Batu 6, Off Jalan Meru, 41050 Klang Selangor, D.E., Malaysia
Re: K993664 Synthetic Vinyl Medical Examination Powdered Trade Name: Gloves Requlatory Class: I LYZ Product Code: Dated: November 27, 1999 December 8, 1999 Received:
Dear Mr. Nooi:
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 requlations 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) requlation (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 requlation 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
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Page 2 - Mr. Nooi
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 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 requlation (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.gpv/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Westmoreland
A. Ulatowski Timothy 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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1.0 Ludications for Use Statement: Include the following or equivalent Indications for Use page. ' Information, data and labeling claims in the culire the 510(k) submission must support and agree v the Indications for Use statement.
| Applicant: | TOP GLOVE SDN. BHD. |
|---|---|
| 510(k) Number (if known): | K993664 |
| Device Name: | SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES |
| Indications For Use: |
Synthetic Vinyl Medical Examination Powdered Gloves are worn on the hands of Health care and similar personnel to prevent contamination between health care personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDEL
Concurrence of CDRH Office of Device Livaluation (ODE)
Clins S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospits 510(k) Number
Prescription Use Per 21 CPR 801.109 ાર
Over-the-Counter
(Optional Forms)
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- For a new submission, do NOT fill in the 510(k) number blank.
§ 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.