(137 days)
This product is a powder free patient examination glove with 50 Micrograms or less of latex protein. It 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.
Powder Free Latex Examination Gloves with Protein Labelling Claim (50 Micrograms or Less)
This document is a 510(k) premarket notification from the FDA, and it does not contain the detailed information about acceptance criteria and study results typically found in a clinical study report or a premarket approval (PMA) application. It focuses on the substantial equivalence of the device (Cranberry Powder-Free Latex Examination Gloves with Protein Content Labeling Claim) to a predicate device.
Therefore, I cannot provide answers to most of your questions based solely on the provided text. The document does not describe the specific testing or studies performed to demonstrate the "50 Microgram or Less" protein content claim or other performance criteria.
However, I can extract the following limited information:
- Device Name: Cranberry Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Microgram or Less)
- Product Code: LYY
- Indications For Use: "This product is a powder free patient examination glove with 50 Micrograms or less of latex protein. It 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." This indication explicitly includes the protein content claim of "50 Micrograms or less," which functions as a performance acceptance criterion for the device's labeling claim.
To answer your full set of questions, one would need to consult the actual 510(k) submission document, which would include the testing protocols and results that support the claims made about the device, particularly the protein content.
In summary, based on the provided text, I can only state that a key performance claim, and therefore a de-facto acceptance criterion for labeling, is a latex protein content of "50 Micrograms or less." The document does not include a study description, sample sizes, expert details, or other specifics of how this criterion was met.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 1900
Mr. Chonq Yoon Tat Director Cranberry (M) Sdn. Bhd. Lot 85, Jalan Portland, Tasek Industrial Estate 31400 Ipoh, Perak Darul Ridzuan, MALAYSIA
Re: K984039 Cranberry Powder-Free Latex Trade Name: Examination Gloves with Protein Content Labeling Claim (50 Microgram or Less) Requlatory Class: Product Code: LYY Dated: January 29, 1999 Received: February 9, 1999
Dear Mr. Chong Yoon Tat
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 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 The general controls provisions of the Act 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. ਸੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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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" (21 CFR 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) 638-20#1 or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/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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510(K) Number (if known): K984039
Devices Names: Powder Free Latex Examination Gloves with Protein Labelling Claim (50 Micrograms or Less)
Indications For Use:
This product is a powder free patient examination glove with 50 Micrograms or less of latex protein. It 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.
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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over The Counter Use X
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number.
(Optional Format 1-2-96)
§ 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.