(76 days)
This glove is a disposable device intended for medical purpose that is worn on the hand of examiner to prevent contamination between patient and examiner.
LATEX PATIENT EXAMINATION GLOVES, POWDER FREE
The provided text is related to an FDA 510(k) clearance for a medical device: "MaxiKleen-Latex Examination Glove Powder-Trade Name: Free", also referred to as "LATEX PATIENT EXAMINATION GLOVES, POWDER FREE".
The document indicates that the device is a Class I medical device and has been determined to be substantially equivalent to legally marketed predicate devices. This means that the device's safety and effectiveness are established by its similarity to existing devices, and a comprehensive study designed to prove specific performance against detailed acceptance criteria, as one might see for a novel or higher-risk device, is not typically required or described in such 510(k) summary documents.
Therefore, I cannot provide the detailed information requested regarding acceptance criteria, study specifics (sample size, data provenance, expert panels, adjudication, MRMC studies, standalone performance), or ground truth establishment for this specific 510(k) clearance. Such information is generally not part of a substantial equivalence determination for Class I devices like examination gloves.
The 510(k) process for this type of device relies on demonstrating equivalence to a predicate device, which implies that the predicate device's established safety and performance are sufficient.
However, I can extract the "Indications for Use" which serve as a high-level description of the device's intended purpose:
Indications For Use:
"This glove is a disposable device intended for medical purpose that is worn on the hand of examiner to prevent contamination between patient and examiner."
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Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services-USA. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the smallest and the bottom profile being the largest. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 1999
Dr. A.S. Tan SinetiMed Latex Sdn. Bhd. 118, Loronq Logam 7 Kamuntaing Raya Industrial Estate, 34600, Taiping, Perak, West Malaysia
K983827 Re : MaxiKleen-Latex Examination Glove Powder-Trade Name: Free Requlatory Class: I Product Code: LYY December 22, 1998 Dated: December 29, 1998 Received:
Dear Dr. Tan:
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 legally marketed predicate 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 The qeneral controls controls provisions of the Act. 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 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Dr. Tan
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 markets 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" (21CFR 807.97). Other qeneral 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/dsma/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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SINETIMED LATEX SDN. BHD.
Lot 118, Jalan Logam 7, Kamunting Raya Industrial Estate 34600 Taiping , Perak Darul Ridzuan, Malaysia. Fax No .: 605-8912999 Tel No.: 605-8912777
1<983827
Indications for Use Statement 3.0
INDICATIONS FOR USE
SINETIMED LATEX SDN. BHD. Applicant
510(k) Number (if know)* :
Device Name : LATEX PATIENT EXAMINATION GLOVES, POWDER FREE
Indications For Use :
This glove is a disposable device intended for medical purpose that is worn on the hand of examiner to prevent contamination between patient and examiner.
PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH Office of Device Evaluation (ODE)
OR Over-The-Counter Prescription Use Per 21 CFR 801.109 (Optional Format 1-2-96)
For a new submission, do NOT fill in the 510(k) number blank.
George A. Miller for Chin S. Lin, Ph.D
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 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.