(106 days)
Not Found
Not Found
No
The summary describes a colored latex examination glove, a physical barrier device, with no mention of software, data processing, or AI/ML terms.
No
This device provides a barrier against contaminants and infectious materials, which is a protective function, not a therapeutic one. It does not treat, cure, mitigate, or prevent disease or injury.
No.
The device is described as a glove intended to provide a barrier against infectious materials and contaminants, not to diagnose a condition or disease.
No
The device description clearly states it is a physical glove made of latex, intended to be worn on the hands or fingers. This is a hardware device, not software.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device's intended use: The intended use of this device is to be worn on the hands or fingers as a barrier against potentially infectious materials and other contaminants. This is a physical barrier function, not a diagnostic test performed on a sample.
- Lack of diagnostic function: The description does not mention any testing of biological samples or any diagnostic purpose. The color is simply an added feature during production.
Therefore, this device falls under the category of a medical device, specifically a medical glove, but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
A colored, powder free and polymer_coated latex examination glove is a disposable device made of natural latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A color, blue, black or pink will be added to the latex examination glove in the production process to produce the colored glove.
Product codes
LYY
Device Description
Colored Powder Free and Polymer Coated Latex Examination Glove (Blue, Black and Pink) with a Protein Claim of Less than 50 ug/gm Glove
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
hands 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 5 2010
Mr. Patrick Leong Chief Operation Officer Tekmedic (M) SDN BHD Plot 4, Tanjung Kling Industrial Area Jetty, Tanjung Kling, Melaka MALAYSIA
Re: K100694
Trade/Device Name: Colored Powder Free and Polymer Coated Latex Examination Glove (Blue, Black and Pink) with a Protein Claim of Less than 50 ug/gm Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: June 9, 2010 Received: June 16, 2010
Dear Mr. Leong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 baye been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Mr. Leong
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony D. m
Anthony B. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Premarket Notification For Colored Powder Free And Polymer Coated Latex Examination Glove (Blue, Black and Pink) With A Protein Claim Of Less Than 50μg/dm²
Indications For Use Statement 3.0
K100694 510(K) Number (if known): ____
Device Name: Colored Powder Free And Polymer Coated Latex Examination Glove (Blue, Black and Pink) With A Protein Claim Of Less Than 50 ug/gm Glove
Indications For Use : A colored, powder free and polymer_coated latex examination glove is a disposable device made of natural latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A color, blue, black or pink will be added to the latex examination glove in the production process to produce the colored glove.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Steven Tuttle for G. Jaya
Concurrence of CDRH, Office(DivisioneSignatualibn (ODE) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KI00694 510(k) Number: ਤੇ