(39 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, Trade Name: Powdered
The provided text is a 510(k) clearance letter from the FDA for "Disposable Vinyl Synthetic Exam Gloves, Trade Name: Powdered". This type of document does not contain acceptance criteria or a study proving device performance in the way you've described for a typical medical device with analytical or clinical performance metrics.
A 510(k) clearance signifies that a device is "substantially equivalent" to a predicate device already legally marketed. This process primarily relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate, or if there are differences, that those differences do not raise new questions of safety and effectiveness.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not on a detailed performance study with specific acceptance criteria, sample sizes, expert ground truth, or statistical analysis.
However, I can extract the following relevant information from the provided document:
- Device Name: Disposable Vinyl Synthetic Exam Gloves, Trade Name: Powdered
- Regulatory Class: I
- Product Code: LYZ
- Indications For Use: "A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER."
- Applicant: Shanghai Palomar Mountain Industries, Incorporated
- FDA Decision: Substantially equivalent to devices marketed prior to May 28, 1976.
- Type of Submission: Premarket Notification (510(k))
- Decision Date: February 19, 1999
To reiterate, the kind of detailed study information you're asking for (acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) is typically found in clinical trial reports, detailed performance studies, or regulatory submissions that go beyond a standard 510(k) clearance letter, especially for Class II or Class III devices, or for devices with more complex functionality that require demonstrable analytical and clinical performance. For a Class I device like examination gloves, the clearance process is significantly less rigorous in terms of performance study requirements.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings spread, depicted with three parallel lines forming the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 1999
Mr. Danny Wang Sales Manager Shanghai Palomar Mountain Industries, Incorporated #1 BIYU Road Cangqiao Township Songjiang County, Shanghai, CHINA, P.R.C.
K990081 Re : Disposable Vinyl Synthetic Exam Gloves, Trade Name: Powdered Regulatory Class: I Product Code: LYZ October 28, 1998 Dated: January 11, 1999 Received:
Dear Mr. Wang
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. ਜੋ 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 requlatory 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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaggov/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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- 3.0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
ONS FOR USE PALOMAR MOUNTAIN INDUSTRIES, INC. Applicant: _ C 510(k) Number (if known): * SYNTHETIC EXAM GLOVES POWDERED Device Name: DISPOSABLE INYL Indications For Use:
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES 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) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use OR Per 21 CFR 801.109 (Optional Format 1-2-96)
Over-The-Counter X
For a new submission, do NOT fill in the 510(k) number blank. ★
Qhin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 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.