(84 days)
A 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.
Chlorinated, Polymer-coated Powder-free Latex Patient Examination Glove, with extractable protein content labeling claim (50 microgram per gram of glove or less)
This document is a 510(k) premarket notification clearance letter for a medical device, specifically a "Chlorinated, Polymer-coated Powder-free Latex Patient Examination Glove." The letter indicates that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
However, this type of document (a 510(k) clearance letter) does not typically contain detailed information about acceptance criteria or specific study results in the way you've requested for performance validation. Instead, it confirms that the manufacturer has submitted sufficient information to demonstrate substantial equivalence to a predicate device, often based on adherence to recognized standards and general safety/performance considerations.
Therefore, I cannot extract the specific information you are asking for (acceptance criteria table, sample sizes for test/training, expert details, adjudication methods, MRMC study results, standalone performance, or detailed ground truth methods) directly from this document. These details would typically be found in the submission's technical documentation, test reports, or clinical study summaries, which are not part of this clearance letter.
The clearance letter focuses on:
- Device Name: Chlorinated, Polymer-coated Powder-free Latex Patient Examination Glove with Extractable Protein Content Labeling Claim (50 Microgram per gram of Glove of Less)
- Regulation Number/Name: 21 CFR 880.6250, Patient Examination Glove, Class I
- Indication for Use: A disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
- Key Claim: "extractable protein content labeling claim (50 microgram per gram of glove or less)" - this implies a specific performance characteristic related to latex protein content, which is often a key criterion for latex gloves.
To answer your questions, one would need access to the actual 510(k) submission and its supporting documentation, not just the FDA's clearance letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kossan Latex Industries (M) Sdn. Bhd. C/O Mr. James F. Logan Medical Reports Exchange, Incorporated 2530 Riva Road, Suite 308 Annapolis, MD 21401
DEC 2 2 2006
Re: K062965
Trade/Device Name: Chlorinated, Polymer-coated Powder-free Latex Patient Examination Glove with Extractable Protein Content Labeling Claim (50 Microgram per gram of Glove of Less) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: December 5, 2006 Received: December 7, 2006
Dear Mr. Logan:
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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Page 2 - Mr. Logan
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely yours,
Anthony D. Watson ber
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
Enclosure
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Indication for Use
510 (K) Number(If known):
Device Name:
大062965
Chlorinated, Polymer-coated Powder-free Latex Patient Examination Glove, with extractable protein content labeling claim (50 microgram per gram of glove or less)
Indication For Use:
A 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.
Prescription Use _ (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula H. Murphy, MD
logy, General Hospi
cal Center, Loric Devices
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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.