(28 days)
A nowder liee patient examination glove is a disposable device made of synthetic material that may bear a tracc annount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.
POWDER FREE NITRILE EXAMINATION GLOVES
The provided document is a 510(k) premarket notification approval letter for "Powder Free Nitrile Examination Gloves" (K993258). It does not contain sections detailing acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to an AI/ML device.
This document is from 1999 and pertains to a physical medical device (gloves), not an AI/ML powered device. Therefore, the requested information categories are not applicable to the content of this document.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 1999
Mr. Stanley Thai Managing Director Managing Director
Supermax Glove Manufacturing Sdn. Bhd. Lot 42, Pultra Industrial Park Bukit Rahman Putra 47000 Sungai Buloh 47666 Bangar Darul Ehsan, Malaysia
Re: K993258
Powder Free Nitrile Examination Gloves Trade Name: Regulatory Class: I Product Code: LZA Dated: September 25, 1999 Received: September 29, 1999
Dear Mr. Thai:
We have reviewed your Section 510(k) notification of intent to we have reviewed your beceion becamed we have determined the market the nevice fereiched above (for the indications for device is substancially cquivated (is success marketed in interstate use stated in the encrosure, co te enactment date of the commerce prior co nay be, or to devices that have been Medical Device Amendices, with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, Food, Drug, and Cosmetic nee (1.00, .
market the device, subject to the general controls provisions market the device, Babject to says of the Act of the Act. The general onnual registration, listing of Include requiremufacturing practice, labeling, and devices, good manabass misbranding and adulteration.
If your device is classified (see above) into cither class II II your device Is childred (bod we market Approval), it may (Special Controls) or Stilling Controls. Existing major be subject to sach address device can be found in the Code of regulations arrecting forms 21, Parts 800 to 895. A Rederal Regulations, frere try ination assumes compliance with substancially equivalent actice for Medical Devices: General the Good Manufacturing Praoch 820) and that, through periodic (GMP) Legulation (2) erk Fard Drug Administration (FDA) will GMF Inspections) choons. Failure to comply with the GMP vertify such abbumpelons. regulatory action. In addition, FDA regulation may resure in the ments concerning your device in
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Page 2 - Mr. Thai
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 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,
Timothy A. Ulatowski
Timothy A. Ulatowski Diredtor 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) : K 993258
DEVICE NAME : POWDER FREE NITRILE EXAMINATION GLOVES
INDICATIONS FOR USE :
A nowder liee patient examination glove is a disposable device made of synthetic material that may bear a tracc annount of glove powder and is intended to be worn on the hand or fingers for medical purposes to provide a barrier against potential infectious materials and other contaminants.
(PLEASE DO NOT WRITE RELOW THIS LINE - CONTINUE ON ANDTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use , (per 21 CFR 801.109)
Over-The-Counter- Use ાર (Optional Format 1-2-96)
Elaine Silin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number .
§ 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.