(60 days)
LaGlove™ Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color) is a disposable patient examination glove which is worn on the hand of a healthcare and similar personnel to prevent contamination between patient and examiner.
LaGlove™ Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color)
The provided text is a 510(k) Premarket Notification from the FDA for medical gloves. It does not contain any information about a study that proves a device meets acceptance criteria in the way you've described for AI/medical imaging devices.
The document is a regulatory approval for "LaGlove™ Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free-Blue Color)", establishing its substantial equivalence to legally marketed predicate devices. This type of regulatory submission for Class I medical devices like examination gloves primarily focuses on:
- Manufacturing standards: Ensuring the gloves are produced under good manufacturing practices.
- Material safety: Demonstrating the materials used are safe for patient contact.
- Performance specifications: Meeting established physical properties for gloves (e.g., tensile strength, puncture resistance, freedom from holes).
The details you've requested (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are typical for the evaluation of diagnostic devices, especially those utilizing AI or complex algorithms for image analysis or disease detection.
Therefore, I cannot provide the requested information based on the provided text because it is not relevant to the type of device and regulatory submission discussed.
To reiterate, this document is a letter from the FDA granting clearance for a physical medical device (examination gloves), not a report on a clinical or performance study involving complex data analysis or AI.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 6 2004
Mr. G. Baskaran Group Managing Director Laglove (M) Sdn. Bhd Lot 478, Jalan Simpang Balak, Off Batu 13, Jalan Cheras, 43000 Kajang, Selangor D.E. MALAYSIA
Re: K042618
Trade/Device Name: LaGlove™ Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free-Blue Color) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: FMC Dated: October 25, 2004 Received: October 27, 2004
Dear Mr. Baskaran:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Carl
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K042618
Device Name: LaGlove™ Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color)
Indications For Use: LaGlove™ Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color) is a disposable patient examination glove which is worn on the hand of a healthcare and similar personnel to prevent contamination between patient and examiner.
Quls
(Division Sign-Off) (Division of Anesthesiology, General Hospital. Infection Control, Dental De
510(k) Number:
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
X
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.