(70 days)
Not Found
Not Found
No
The device description and intended use clearly indicate that the device is a powdered latex examination glove, which is a physical barrier and does not involve any computational or analytical technology like AI/ML. The "Not Found" entries for AI/ML mentions, image processing, training/test sets, and performance studies further support this conclusion.
No
The device, powdered latex examination gloves, is intended to prevent contamination, not to treat or cure a disease or condition.
No
The device, powdered latex examination gloves, is described as being worn to prevent contamination, not to diagnose any condition.
No
The device description clearly states it is "POWDERED LATEX EXAMINATION GLOVES," which are physical hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between healthcare personnel and the patient by being worn on the hands. This is a barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the material (latex), form (powdered), and protein content of the gloves. This aligns with a medical device used for protection, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
POWDERED LATEX EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALITE CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.
Product codes
LYY
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
HEALITE 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 (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 and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 1999
Mr. Wee Chai Lim Director Top Glove Sdn. Bhd. Lot 4968, Jalan Teratai, Batu 6, Off Jalan Meru 41050 Klang, Selangor D.E. MALAYSIA
Re: K990468 Powdered Latex Examination Gloves W/Protein Trade Name: Labeling (100 Micrograms or Less Per Gram) Requlatory Class: I Product Code: LYY February 11, 1999 Dated: February 16, 1999 Received:
Dear Mr. W.C. Lim:
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 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). 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 (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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
1
Page 2 - Mr. W.C. Lim
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 premarket notification" (21CFR 807.97). Other qeneral 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/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
2
1
0 Indications for Use Statement: Include the following or equivalent Indications for Use page. The formation, data and labeling claims in the entire 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): | K990468 |
| Device Name: | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELLING (100 MICROGRAM OR LESS) |
Indications For Use:
: :---------------------------------------------------------------------------------------------------------------------------------------------------------------------------
and and submitted and the film the first in the lands in the first in the first in the first in the first in the first in the first in the first in the first in the first in
POWDERED LATEX EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALITE CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.
(PLEASE DO NOT WRITE BELOW TINS LINE - CONTINUE ON AND THER PAGE 11 NEBULU)
Concurrence of CDRH Office of Dovice Evaluation (ODE)
Chin S. Lim
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devices 510(k) Number
OR
Over-the-Counter
Prescription Une Por 21 CFR 801.109 ()[{{
(Optional Formal 1-2-96)
· For a new submission, do NVT fill in the 510(k) number blank.