(29 days)
Not Found
Not Found
No
The summary describes a standard medical glove and contains no mention of AI or ML technology.
No
Explanation: The device is a patient examination glove, intended to provide a barrier against contaminants, which is a preventive measure rather than a treatment for a disease or condition.
No
The device is a glove for providing a barrier against infectious materials, not for diagnosing medical conditions.
No
The device is a physical medical device (gloves) and does not involve any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Description: The description clearly states the device is a "Powdered Patient Examination Glove" intended to be worn on the hands as a barrier. This is a physical barrier device, not a device that performs tests on biological samples.
- Intended Use: The intended use is to provide a barrier against infectious materials and contaminants, which is a protective function, not a diagnostic function.
The information provided confirms this is a standard medical glove, not an IVD.
N/A
Intended Use / Indications for Use
A Powdered Patient Examination Glove is a Disposable Device made of Natural Rubber Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
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
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a symbol that resembles a stylized caduceus, with a staff and a serpent winding around it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ravi Abraham Managing Director Kana Latex Industries Pvt. Ltd. Ooppoottil Building P.O. Box #28K.K. Road Kottayam, 686 001 KERALA, INDIA
Re: K052214
K032214
Trade/Device Name: Pre-Powdered Sterile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: September 1, 2005 Received: September 8, 2005
Dear Mr. Abraham:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premained is substantially equivalent (for the indications referenced above and have determined the asketed predicate devices marketed in interstate for use stated in the encrosule) to regally manation to of the Medical Device Amendments, or to commerce prior to May 28, 1770, the enacement with the provisions of the Federal Food. Drug. devices that have been reciassified in accordance "Harroval application (PMA).).
and Cosmetic Act (Act) that do not require approval of a presidions of the Act. The and Cosmetic Act (Act) that to not require approvate of the general controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, l You may, therefore, market the devree, seejoer to the g
general controls provisions of the Act include requirements for annual registrations in and general controls provisions of the Feet mendas requires against misbranding and adulteration.
SEP 1 3 2005
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) nils crisi and major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FD may be subject to such adultional controller "Littering on "Friday" on addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Peachar Regaring your device in the Federal Register.
1
Page 2 - Mr. Abraham
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualic of a succeunter volto the requirements of the Act
that FDA has made a determination that your device aloganies. Your must that FDA has made a delefinination and your areas by other Federal agencies. You must or any Federal statures and regulations administered of registration and listing (21 l
comply with all the Act's requirements, including, but not as seguirements as set comply with all the Act s requirements, micrasis, can manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); gract 800); and if explicable, the CFR Part 807); labeling (21 CFR Part on ); good management (200); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050 forth in the quality systems (QS) regulation (21-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Acction S product radiation control provisions (Sections 991 device as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a le This letter will allow you to oegill makemig your antile equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, n premarket notification. The PDA Inding of substantial equivalier of your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
nto lead the many of the same of 14 5 - Allery and association entitled If you desire specific advice int your de not on our and the regulation entitled, the regulation entitled, the may obtain contact the Office of Comphalice at (240) 270 - 117 - 1210, FR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You ma "Misbranding by reference to premarket nonfreadonder the Act from the Division of Small
other general information on your responsibilities under the Act from worker (800) 638 other general information on your responsionities and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free humber (ind Manufacturers, International and Consumer I Isolomico around of the manufactures html.
Sincerely yours,
Qurs
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ENCLOSURE - II
Indications for Use
510(k) Number (if known): _K052214
Device Name: PRE-POWDERED LATEX STERILE PATIENT EXAMINATION GLOVES
Indications for Use:
A Powdered Patient Examination Glove is a Disposable Device made of Natural Rubber Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
For Karam Latex Industries Pvt. Ltd.
R. Abraham
Ravi Abraham
Mg. Director
: 上一
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _X (21 CFR 801 Subpart C)
LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Shuh. W. Munday, R2, 428, 9/13/05
Division of Anesthesiology. General Hospital. ncurrence of CDRH, Office of Device Evaluation (ODE)
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