(98 days)
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Not Found
No
The 510(k) summary describes a standard examination glove and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device, a patient examination glove, is intended for preventing contamination, not for treating a medical condition or ailment.
No
Justification: The device is an examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device description clearly states it is a physical product (examination gloves) and does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a "patient examination glove" worn on the hand or finger.
- Intended Use: The intended use is to "prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample.
The device described is a medical device, specifically a Class I medical device (examination glove), but it does not fit the definition of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Laglove TM Brand Nitrile Examination Gloves, Powdered, Non - Sterile (Pink Color) is a patient examination glove is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
Laglove TM Brand Nitrile Examination Gloves, Powdered, Non-Sterile. (Pink Color)
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
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Indicated Patient Age Range
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Intended User / Care Setting
medical purpose worn on the examiners hand or finger
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles an abstract representation of a bird or a human figure with outstretched arms.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
FEB 2 2 2010
Mr. G. Baskaran Group Managing Director Laglove (M) Sdn. Bhd Lot 478, Jalan Simpang Balak Off Batu 13, Jalan Cheras, 43000 Kajang Selangor Darul Ehsan MALAYSIA
Re: K092498
Trade/Device Name: Laglove™ Brand Nitrile Examination Gloves, Powdered, Non- Sterile (Pink) Regulation Number: 21CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: October 9, 2009 Received: October 19, 2009
Dear Mr. Baskaran:
This letter corrects our substantially equivalent letter of October 9, 2009.
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 have 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 (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.
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.
1
Page 2- Mr. Baskaran
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Anthony D. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for use 3.0
| Applicant | : LAGLOVE (M) SDN. BHD. |
|---|---|
| 510(k) number | : K092498 |
| Device name | : Laglove TM Brand Nitrile Examination |
| Gloves, Powdered, Non-Sterile. | |
| (Pink Color) | |
| Indications for use | : Laglove TM Brand Nitrile Examination |
| Gloves, Powdered, Non - Sterile | |
| (Pink Color) is a patient examination | |
| glove is a disposable device intended for | |
| medical purpose worn on the examiners | |
| hand or finger to prevent contamination | |
| between patient and examiner. |
Preseription Use (Part 21 GFR 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F. Clunie-Wells
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092498
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01/13/10 5 Doc. Ref. : LG/510(k)/NExPWPK