(50 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and the patient.
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES. WITH WATER EXTRACTABLE PROTEIN LABELLING CLAIN 100 micron or lease of tatal with extracts
The provided document is a 510(k) premarket notification letter from the FDA to Alliance Rubber Products Sdn. Bhd. for "Polymer Coated Powder Free Latex Examination Gloves." This document does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment for an AI/ML powered device.
It is a clearance letter for a medical device (latex examination gloves) and primarily discusses:
- The FDA's determination of substantial equivalence for the gloves to legally marketed predicate devices.
- Regulatory classifications and general controls applicable to the device.
- Instructions for the company regarding marketing, labeling, and other regulations.
- The intended use of the gloves, which is "a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and the patient."
Therefore, I cannot provide the requested information based on this document.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 1999
Chua Hooi Koon Alliance Rubber Products Sdn. Bhd. Lot 2716 & 2720, MK7 Kawasan Perindustrian Bukit Panchor 14300 Nibong Tebal Pulau Pinang, Malaysia
Re : K992870 Polymer Coated Powder Free Latex Examination Trade Name: Gloves Requlatory Class: I LYY Product Code: Dated: August 19, 1999 Received: August 26, 1999
Dear Chua Hooi Koon:
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, labeling, and prohibitions aqainst 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 Regulations, Title 21, Parts 800 to 895. ਜੋ 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
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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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 requlation 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,
Susan Pinson
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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Image /page/2/Picture/0 description: The image shows the logo for Alliance Rubber Products Sdn.Bhd. The logo consists of a stylized graphic to the left of the company name. The graphic is a black, intertwined design. The company name is written in a serif font.
Lot 2716 & 2720, MK7, Kawasan Perindustrian Bukit Panchor, 14300 Nibong Tebal, Company No. 52446-U Pulau Pinang, Malaysia. Fax : (04)-5932262, 3322034 E-mail : allianc@po.jaring.my Tel : (04)-5932235, 5937616 Our Ref : CHK/190899/18 Date : 19/08/99 Page : 1/1 Your Ref :
ATTACHMENT 2 :
INDICATION FOR USE
Applicant : ALLIANCE RUBBER PRODUCTS SDN. BHD.
K992870 510(k) Number (if known) : ___________________________________________________________________________________________________________________________________________________
Device Name : POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES. WITH WATER EXTRACTABLE PROTEIN LABELLING CLAIN 100 micron or lease of tatal with extracts Trade Name : (1) SAFEPLUS
(2) Other clients private labeling
Indication For Use :
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE)
Qhis S. Lin
(Division Sign-Off) Division of Dental, Infection Control and General Hospital 510(k) Number
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter
§ 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.