(42 days)
Not Found
Not Found
No
The summary describes a medical glove, a physical barrier device, with no mention of software, data processing, or AI/ML terms.
No.
The device, "Synthetic Vinyl Medical Examination Powder Free Gloves," is intended for use by healthcare personnel to prevent contamination, not to treat a disease, injury, or condition.
No
The device is a glove, which is used for contamination prevention during medical examinations, not for diagnosing any medical conditions.
No
The device is a physical glove, not software. The description clearly states it is a "SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE" worn on the hands.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of these gloves is to be worn on the hands of healthcare personnel to prevent contamination. They do not involve the examination of any biological samples.
- The description focuses on a physical barrier. The device description and intended use clearly indicate that the gloves function as a physical barrier for protection, not for diagnostic purposes.
The information provided aligns with a Class I medical device (general controls) that is a personal protective equipment (PPE).
N/A
Intended Use / Indications for Use
Synthetic Vinyl Medical Examination Powder Free Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
Product codes
LYZ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care and similar personnel
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
Not Found
Key Metrics
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 is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The caduceus is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 1999
Mr. Loo Sun Nooi Assistant QA Manager Top Glove Sdn. Bhd. Lot 4968 Jalan Teratai Batu 6 Off Jalan Meru 41050 Klang, Selangor D.E., Malaysia
Re: K993680 Synthetic Vinyl Medical Examination Powder Trade Name: Free Gloves Requlatory Class: I Product Code: LYZ November 23, 1999 Dated: November 29, 1999 Received:
Dear Mr. Nooi:
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 Regulations, Title 21, Parts 800 to 895. ಕ substantially equivalent determination assumes compliance with the Good Manufacturinq 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
1
Page 2 - Mr. Nooi
obligation you might have under sections 531 through 542 of obligation you might have ahaor betronic Product Radiation the Act for devices ander on Federal laws or regulations.
This letter will allow you to begin marketing your device as This icecci will arenarket notification. The FDA described in your 510 (i) p=umance of your device to a legally Finding of Subscancial Oquination a classification for your marketed predicate device rubablice to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific advice additionally 809.10 for in regulacion (21 crk rares), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriated as (od advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation encreased, "histian" (1) Other general premation on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance obtained from the Division of 638-2044 or (301) 443-6597 or at at its coll-free namber (05)/www.fda/gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timoth Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
3.0 Ludications for Use Statement: Include the following or equivalent Indications for Use page. The Information, data and labeling claims in the cultie the 510(k) submission must support and agree with the Indications for Use statement.
INDICATIONS FOR USE
| Applicant: ___________________________________________________________________________________________________________________________________________________________________ | TOP GLOVE SDN. BHD. | |||||
|---|---|---|---|---|---|---|
| 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ | 993680 | |||||
| Device Name: _________________________________________________________________________________________________________________________________________________________________ | SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVE |
Indications For Use:
Synthetic Vinyl Medical Examination Powder Free Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Clim S. Lin
sion Sign-Off) on of Dental, Infection C General Hospi «» Number
Prescription Uso Per 21 CPR 801.109
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Over-Ilo-Counter
(Optional Pormal 1-
- For a new submission, do NOT fill in the 510(k) number blank.