(82 days)
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Not Found
No
The summary describes a patient examination glove and contains no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics associated with AI/ML algorithms.
No
The device, a patient examination glove, is intended for preventing contamination, not for treating any medical condition or disease.
No
The device is described as a "patient examination glove," which is used to prevent contamination between a patient and examiner. Its function is to provide a barrier, not to diagnose any condition or disease.
No
The device description clearly states it is a physical glove made of latex and nitrile, which are hardware 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 "patient examination glove...worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a physical barrier device used during patient examination.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to provide information about a person's health.
- Lack of IVD Characteristics: The description of the glove does not involve any testing of biological samples, analysis of bodily fluids, or diagnostic procedures performed outside the body. It is a physical barrier used during a physical examination.
Therefore, the device described is a medical device, but it falls under the category of a Class I or Class II medical device (depending on the specific regulations and risk classification) rather than an IVD.
N/A
Intended Use / Indications for Use
A 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.
Product codes
LYY
Device Description
Pre-Powdered Multi-ply Latex Patient Examination Glove (Natural Rubber Latex-Nitrile-Construction) with Protein Content labeling claim 68.25 micrograms or less per gram of gloves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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 U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an abstract human figure, represented by three curved lines that resemble a person's head and shoulders.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 1999
Mr. Said Awang Product Development & Technical QA Pamitex Industries Sdn. Bhd. Batu 2½ Jalan Rasah 70300 Seremban Negeri Sembilan Darul Khusus, Malaysia
Re : K992523
Health-Plus Sanitex, Reliance Pre-Powdered Trade Name: Multi-Ply Latex Examination Glove (Natural Rubber Latex-Nitrile-Construction with Protein Content Label Claim (68.25 micrograms or less per glove) Requlatory Class: I Product Code: LYY July 14, 1999 Dated: Received: July 28, 1999
Dear Mr. Awang:
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 aqainst 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. ਉ 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
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Page 2 - Mr. Awang
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 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 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 requlation (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 requlation entitled, "Misbranding by reference to premarket notification" (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 its internet address "http://www.fda.gov/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
510(k) Number (if known): ------ K 99.2 ≤ ≤ 2 3 ------------------------------------------------------------------------------------
DEVICE NAME : Pre-Powdered Multi-ply Latex Patient Examination Glove (Natural Rubber Latex-Nitrile-Construction) with Protein Content labeling claim 68.25 micrograms or less per gram of gloves.
INDICATIONS FOR USE:
A 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE 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
(Optional Format 1-2-95)
Oliver S. Làn
(Division Sign-Off) Division of Dental, Infection Cor and General Hospital 1 1 (k) Number _