(182 days)
Not Found
Not Found
No
The summary describes a standard medical glove and contains no mention of AI, ML, or related concepts.
No
The device is a patient examination glove, which is intended to prevent contamination and is not designed to treat a disease or condition.
No
Explanation: The device, a patient examination glove, is for preventing contamination and is worn on the hand or finger. It does not perform any diagnostic function.
No
The device description clearly states it is a physical product (Latex Patient Examination Gloves) and does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The description clearly states the device is a "patient examination glove" intended to be worn on the hand or finger to prevent contamination. This is a barrier device used for infection control during physical examinations.
- Lack of Diagnostic Function: The device does not perform any test on a biological sample to provide diagnostic information. Its purpose is purely protective.
The information provided about the device's intended use and description confirms it is a medical device, but specifically a Class I or Class II medical device (depending on the specific regulations and risk classification), not an IVD.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners.
Product codes
LYY
Device Description
Latex Patient Examination Gloves BUBBLE GUM FLAVOR PRE-POWDERED
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's, medical purpose
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1998 NOV
Mr. John a. Tapocik Director Plak Smacker®, Incorporated 4105 Indus way Riverside, California 92503
K981600 Re : Latex Examination Gloves Bubble Gum Trade Name: Flavored Pre-Powdered Requlatory Class: I Product Code: LYY September 30, 1998 Dated: Received: October 5, 1998
Dear Mr. Tapocik:
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 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) regulation (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. Please note: this response to your premarket notification 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.
1
Page 2 - Mr. Tapocik
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberroom 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 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
Timothy Direc tor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows a series of handwritten numbers and letters. The sequence starts with the letter 'K', followed by the numbers '981600'. The handwriting style is cursive, with some characters connected to each other.
ANNEXURE II
INDICATION FOR USE
| Applicant | : Mr. John A. Tapocik |
|---|---|
| Device Name | : Latex Patient Examination Gloves |
| BUBBLE GUM FLAVOR PRE-POWDERED |
Indication for use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
10R
Over-The-Counter Use X
(Optional Format 1-2-96)
Qun S. Lim
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
(-96)