(113 days)
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Not Found
No
The summary describes a simple medical device (examination gloves) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is a barrier against contaminants, not for treating a disease or condition.
No
Explanation: The device is described as a glove intended to provide a barrier, which is a protective function, not a diagnostic one. There is no mention of it being used to identify or analyze a medical condition.
No
The device description clearly states it is a physical product (gloves) and does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a barrier worn on the hand or fingers for medical purposes to protect against infectious materials and contaminants. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The description "Powdered Latex Examination Gloves, Non-sterile" further reinforces its nature as a physical barrier device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Detecting or measuring substances in specimens.
- Providing information for diagnosis, monitoring, or screening.
- Using reagents or assays.
Therefore, this device falls under the category of a medical device used for protection and barrier purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A powdered patient examination glove is a disposable device made of natural rubber latex that bears powder to facilitate donning and is intended to be worn on the hand or finger (s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Product codes
LYY
Device Description
Powdered Latex Examination Gloves, Non-sterile
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand or finger(s)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 2000
Mr. Goh Seok Huei Quality Management Representative Multisafe Sdn. Bhd. Lot 764, Bidor Industrial Estate 35500 Bidor, Perak Darul Ridzuan Malaysia
Re : K993811 Multisafe Powedered Latex Examination Trade Name: Gloves, Nonsterile Regulatory Class: I Product Code: LYY February 11, 2000 Dated: February 16, 2000 Received:
Dear Mr. Huei:
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. 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 regulation 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
1
Page 2 - Mr. Huei
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 described in your in four equivalence of your device to a legally marketed predicate device results in a classification for your marketca predicato amits 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) 594-4690. 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 regaration" (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 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
2
MULTISAFE SDN BHD (236507-X)
( A MEMBER OF THE YEE LEE GROUP)
LOT 764, BIDOR INDUSTRIAL ESTATE, 35500 BIDOR, PERAK DARUL RIDZUAN. TEL: 05-4348269 - 72 FAX:05-4348266
510(K) Number (If known): K993811
Devices Names : Powdered Latex Examination Gloves, Non-sterile
Indications For Use :
:
ﺔ ﺍﻟﻤ
A powdered patient examination glove is a disposable device made of natural rubber latex that bears powder to facilitate donning and is intended to be worn on the hand or finger (s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
(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) | OR | Over The Counter Use | X |
|---|---|---|---|
| ------------------------------------------ | ---- | ---------------------- | --- |
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
(Optional Format 1-2-96)
| 510(k) Number | K993811 |
|---|---|
| --------------- | --------- |