(28 days)
A patient Vinyl Exam 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.
Vinyl, Patient Exam Gloves, Powdered
This document is a 510(k) clearance letter from the FDA for a Vinyl Powdered Examination Glove. It is primarily a regulatory communication and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) or de novo submission might.
Therefore, I cannot provide the requested information from the given text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts and their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm-only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document states the device is "substantially equivalent" to pre-amendments devices and focuses on regulatory compliance (GMP, labeling, etc.). For examination gloves, the performance criteria typically relate to things like barrier integrity (e.g., freedom from holes), tensile strength, and dimensions, which are usually tested according to industry standards, but these details are not present in this regulatory letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 4 1999
Ms. Ginger Talley Official Correspondent Ouality Assurance VitalCare Group, Incorporated 15800 N.W. 13 Avenue Miami, Florida 33169
Re : K992289 Vinyl Powdered Examination Glove/ Trade Name: Cat. #15-020 Regulatory Class: I Product Code: LYZ Dated: June 30, 1999 Received: July 7, 1999
Dear Ms. Talley:
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. 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Talley
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of 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 regulation (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 ene regaración Shorosou, Marketing () 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.fdg.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Direct br Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Applicant: VitalCare Group, Inc. 15800 N.W. 13th Avenue Miami, FL 33169
Kaa2289 510(k) Number (if Known): __
Device Name: Vinyl, Patient Exam Gloves , Poe dered
Indications for use: A patient Vinyl Exam 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.
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use __
Ot
E
Over-The-Counter X
Chiu S. Lin
510(k)
§ 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.