(149 days)
This product is a patient examination glove. 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.
Nitrile Powder Free Examination Glove - Cranberry
This document is a 510(k) premarket notification decision letter from the FDA for Nitrile Powder-Free Examination Gloves. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of the requested AI/medical device study information.
The document indicates that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It pertains to a physical medical device (examination gloves) and not an AI/software as a medical device.
Therefore, I cannot provide the requested information such as:
- A table of acceptance criteria and the reported device performance: Not applicable, as this is a physical device clearance based on substantial equivalence, not performance metrics against specific criteria.
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone performance was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 1999
Mr. Chong Yoon Tat Director Cranberry (M) Sdn. Bhd. Lot 85, Jalan Portland Tasek Industrial Estate 31400 Ipoh, Perak Darul Ridzuan MALAYSIA
Re : K983334 Nitrile Powder-Free Examination Gloves Trade Name: Requlatory Class: I Product Code: LZA Dated: January 15, 1999 January 19, 1999 Received:
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 aqainst 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 requlations 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 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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Page 2 - Mr. Chong Yoon Tat
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 findinq 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 requlation 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) 638-2041 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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CRANBERRY (M) SDN. BHD. (104994 - w9 (A MEMBER OF THE YEE LEE GROUP)
Lot 85, Jalan Portland, Tasek Industrial Estate, 31400 Ipoh, Perak Darul Ridzuan, Malaysia. Cor 60, 005 1055 / 546 1055 Fax: (05) 547 3962 / 547 9862 Telex: YLOIL MA 44556
Applicant : CRANBERRY (M) SDN. BHD. LOT 85, JALAN PORTLAND, TASEK INDUSTRIAL ESTATE, 31400, IPOH, PERAK, MALAYSIA
510(k) Number (if known): $983334
Device Name: Nitrile Powder Free Examination Glove - Cranberry
Indications For Use:
This product is a patient examination glove. 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chiu S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number
Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use
X
§ 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.