(56 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Syntex Powder-Free Polymer-Coated Nitrile Examination Gloves
This document is a 510(k) premarket notification letter from the FDA regarding "Syntex Powder-Free Polymer-Coated Nitrile Examination Gloves." It confirms the device's substantial equivalence to legally marketed predicate devices and permits its marketing.
The request for "acceptance criteria and the study that proves the device meets the acceptance criteria" is not applicable to this document. This letter is an FDA clearance, not a study report. It does not contain information about:
- A table of acceptance criteria and the reported device performance: This document does not detail specific performance criteria or test results.
- Sample size used for the test set and the data provenance: No test set details are provided.
- Number of experts used to establish the ground truth...: This is irrelevant to an FDA clearance letter for examination gloves.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device (gloves), not an AI algorithm.
- 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.
The document indicates that the device is "substantially equivalent" to legally marketed predicate devices. For examination gloves, this typically means demonstrating performance parameters (like barrier integrity, tensile strength, freedom from pinholes) that meet recognized consensus standards (e.g., ASTM standards) to be as safe and effective as existing gloves on the market. However, the details of these tests and their results are not present in this specific FDA clearance letter. Such information would be found in the 510(k) submission itself, not in the clearance letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 022002
Mr. Tan Swu Choon Deputy General Manager Syntex Healthcare Products Company Limited No. 1 Fanjiazhung Industrial Zone Xinii City, Hebei Province, CHINA 052360
Re: K020751
Trade/Device Name: Syntex Powder-Free Polymer-Coated Nitrile Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: February 28, 2002 Received: March 7, 2002
Dear Mr. Choon:
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. Tan Swu Choon
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 modified in any Federal statutes and regulations administered by other Federal agencies. or and rest of 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 and iboms (2) 02 11 1 1 1 1 4 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 5100(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 and additionally 21.CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
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): _K 02075/
Powder-Free Polymer-Coated Nitrile Device Name : Examination Glove
Indication For Use :
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A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: OR Over The Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-95)
Oline S. lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number J
§ 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.