(113 days)
A powdered patient examination glove is a disposable device made of natural rubber latex that bears powder to facilitate donning and is intended to be worn on the hand or finger (s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Powdered Latex Examination Gloves, Non-sterile
This document is a 510(k) clearance letter from the FDA for "Multisafe Powdered Latex Examination Gloves, Nonsterile." It does not contain any information regarding acceptance criteria, study details, or device performance metrics like sensitivity, specificity, or accuracy that would be relevant to AI/ML medical devices.
The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It refers to general controls, GMP regulations, and labeling requirements.
Therefore, it is impossible to extract the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) for an AI/ML device from this document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 2000
Mr. Goh Seok Huei Quality Management Representative Multisafe Sdn. Bhd. Lot 764, Bidor Industrial Estate 35500 Bidor, Perak Darul Ridzuan Malaysia
Re : K993811 Multisafe Powedered Latex Examination Trade Name: Gloves, Nonsterile Regulatory Class: I Product Code: LYY February 11, 2000 Dated: February 16, 2000 Received:
Dear Mr. Huei:
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 Regulations, 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 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. Huei
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 described in your in four equivalence of your device to a legally marketed predicate device results in a classification for your marketca predicato amits 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) 594-4690. 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 ene regaration" (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 at its internet address "http://www.fdaggov/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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MULTISAFE SDN BHD (236507-X)
( A MEMBER OF THE YEE LEE GROUP)
LOT 764, BIDOR INDUSTRIAL ESTATE, 35500 BIDOR, PERAK DARUL RIDZUAN. TEL: 05-4348269 - 72 FAX:05-4348266
510(K) Number (If known): K993811
Devices Names : Powdered Latex Examination Gloves, Non-sterile
Indications For Use :
:
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A powdered patient examination glove is a disposable device made of natural rubber latex that bears powder to facilitate donning and is intended to be worn on the hand or finger (s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
| Prescription Use(Per 21 CFR 801.109) | OR | Over The Counter Use | X |
|---|---|---|---|
| ------------------------------------------ | ---- | ---------------------- | --- |
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
(Optional Format 1-2-96)
| 510(k) Number | K993811 |
|---|---|
| --------------- | --------- |
§ 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.