(93 days)
The Glove Seal D'Pro Latex Examination glove is a disposable patient examination glove that is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Glove Seal D'Pro Latex Examination Glove, Powdered with 100 mcgm or Less of Total Water Extractable Protein Per Gram
The provided text is a 510(k) clearance letter from the FDA for a latex examination glove. This type of document does not contain the acceptance criteria or a study description as typically found for complex AI/ML-driven medical devices.
The FDA 510(k) clearance process for devices like examination gloves primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves:
- Performance Standards: Glov_es are subject to various ASTM standards regarding tensile strength, elongation, barrier integrity (pinholes), and often protein levels for latex gloves to address allergic reactions.
- Biocompatibility: Tests to ensure the materials are not harmful to human tissue.
- Labeling and Manufacturing: Adherence to good manufacturing practices (GMP) and appropriate labeling.
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 legally marketed predicate devices."
Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria and study details as it pertains to AI/ML device evaluations. The document relates to a simple medical device (examination glove) and its regulatory clearance process, which does not involve AI performance studies.
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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 1999
Mr. Vinayagan Ramalingam Contract Latex Dippers Sdn. Bhd. No. 11, 2nd Floor Jalan Sri Hartamas 7, 50480 Kuala Lumpur, MALAYSIA
K983570 Re : Glove Seal D'Pro Latex Examination Glove, Trade Name: Powdered with 100 mcgm or Less of Total Water Extractable Protein Per Gram Requlatory Class: I Product Code: LYY December 12, 1998 Dated: December 30, 1998 Received:
Dear Mr. Ramalingam:
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 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 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 Requlations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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 - Mr. Ramalingam
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" (21CFR 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.qov/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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3.0 Indications for Use Statement:
Contract Latex Dippers Sdn Bhd
510(k) Number: Device Name: Indications for Use:
Applicant:
Glove Seal D'Pro Latex Examination Glove, Pour due turitte
The Glove Seal D'Pro Latex Examination glove is a disposable patient examination glove that is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Reorge l. Zuli
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
FDA
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§ 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.