(78 days)
Not Found
Not Found
No
The device description and intended use clearly describe a standard examination glove, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device, an examination glove, is intended to prevent contamination, not to provide therapy or treatment for a disease or condition.
No
The device is described as an "Examination glove" which is used to prevent contamination. There is no indication that it is used to diagnose any condition.
No
The device description clearly states it is a physical product (examination gloves) and does not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to be worn on the hand or finger to prevent contamination during examination. It does not involve testing or analyzing biological samples.
- The description focuses on a physical barrier. The device description and intended use clearly indicate its function as a protective barrier, not a diagnostic tool.
This device is a medical device, specifically a Class I medical device (general controls) or potentially a Class II medical device (special controls) depending on the specific type and claims, but it is not an IVD.
N/A
Intended Use / Indications for Use
An Examination glove is a disposable device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Product codes
LYY
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2003
Mr. Joseph J. E. Pereira Managing Director Sanrea Healthcare Private Limited Plot No. 14-C, Cochin Special Economic Zone, Kakkanad, Cochin-682037 Kerala. INDIA
Re: K023910
Trade/Device Name: Powder-free Sterile Latex Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: January 16, 2003 Received: January 21, 2003
Dear Mr. Pereira:
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 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Pereira
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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SANREA HEALTHCARE PRIVATE LIMITED
PLOT NO. 14-C, COCHIN SPECIAL ECONOMIC ZONE, KAKKANAD, COCHIN - 682037, KERALA, INDIA P : 422514, 422826, 423211, Fax : 91 484 - 422541, E-mail : sarea@ys1.net
ENCLOSURE-II
INDICATIONS FOR USE
| APPLICANT | SANREA HEALTHCARE PVT LTD |
|---|---|
| 510 (k) NO | K023910 |
| DEVICE NAME | POWDERFREE STERILE LATEX |
| EXAMINATION GLOVES |
INDICATIONS FOR USE.
An Examination glove is a disposable device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Qum Si Lin
(Division Sign-Off) Division of Anesthesiology Infection Control, Den
510(k) Number: K023910