(189 days)
IS A PATIENT EXAMINATION GLOVE WHICH IS A DISPOSABLE MEDICAL DEVICE INTENDED FOR MEDICAL PURPOSES THAT ARE WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT (50 MICROGRAMS OR LESS)
This document is a 510(k) premarket notification decision letter from the FDA to Oon Corporation Resources (M) Sdn. Bhd. regarding "Powder-Free (Chlorinated) Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms Or Less)."
This letter approves the device for marketing due to its substantial equivalence to legally marketed predicate devices. However, the document does not contain specific acceptance criteria, study details, or performance data beyond the device's labeling claim of "50 Micrograms Or Less" for protein content.
Therefore, I cannot provide the requested information about acceptance criteria, study design, sample sizes, ground truth establishment, or expert information because:
- Acceptance Criteria and Reported Device Performance: These are not explicitly stated in the provided text. The letter only mentions a "Protein Content Labeling Claim (50 Micrograms Or Less)," which implies a performance characteristic but doesn't define formal acceptance criteria against a specific standard or test.
- Study Details (Sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth type, training set size, training ground truth): The document is a regulatory approval letter based on an application, not the study report itself. It does not describe the specific studies or data submitted by the manufacturer to support their claims. It only confirms the FDA's review and determination of substantial equivalence.
In summary, the provided text confirms the regulatory status of the device but lacks the detailed scientific study information requested.
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DEC 7 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Clement K.K. Oon Executive Director Oon Corporation Resources (M) Sdn. Bhd. Lot 59, Senawang Industrial Estate 70450 Seremban, Negeri Sembilan Darul Khusus MALAYSIA
K981917 Re : Powder-Free (Chlorinated) Latex Examination Trade Name: Gloves with Protein Content Labeling Claim (50 Micrograms Or Less) Regulatory Class: I LYY Product Code: October 14, 1998 Dated: October 21, 1998 Received:
Dear Mr. Oon:
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 reqistration, 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (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 Register. 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. Oon:
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 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 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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Applicant: __ OON_CORP_RESQURCES_(M)SUN_BU1 510(k) Number (if known): CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT
Device Name: Device Name. - Gibbeling CARDERING (50 MICROGRAMS OR LESS)
IS A PATIENT EXAMINATION GLOVE WHICH IS A DISPOSABLE MEDICAL DEVICE INTENDED FOR MEDICAL PURPOSES THAT ARE WORN ON THE EXAMINER'S HAND 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)
Prescription Usc Per 21 CFR 801.109 (Optional Format 1-2-96) OR Over-The-Counter
Olin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 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.