(35 days)
Not Found
Not Found
No
The 510(k) summary describes a standard examination glove and contains no mention of AI, ML, or any related technologies.
No
The device is described as an examination glove intended to prevent contamination, not to treat a medical condition or disease.
No
The device is described as an examination glove intended to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device description clearly identifies it as a physical examination glove made of synthetic materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a glove worn on the hand or finger to prevent contamination between patient and examiner. This is a physical barrier device used during medical examinations.
- Device Description: It's described as an examination glove.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not perform any such analysis.
Therefore, the Synthalon® PI Powder-free Synthetic Polyisoprene/Polychloroprene Examination Glove is a medical device, but it falls under a different classification than an IVD.
N/A
Intended Use / Indications for Use
The Synthalon® PI Powder-free Synthetic Polyisoprene/Polychloroprene 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
LZA
Device Description
Synthalon® PI Powder-free Synthetic Polyisoprene/Polychloroprene Examination Glove
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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 logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white and appears to be a simplified or vectorized version.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2006
Mr. Victor J Ragucci Chairman and CEO BarrierMed Glove Company 155 Technology Park Lake Mary, Florida 32746
Re: K060733
Trade/Device Name: Synthalon® PI Powder-Free Synthetic Polyisoprene/ Polychloroprene Examination Glove Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LZA P Dated: April 17, 2006 Received: April 18, 2006
Dear Mr. Ragucci:
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 offecting 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. Ragucci
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours.
Chiú 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
3.0 Indications for Use Statement:
INDICATIONS FOR USE
Applicant: BarrierMed Glove Co.®
510(k) Number (if known):* K110733
Device Name: Synthalon® PI Powder-free Synthetic Polyisoprene/Polychloroprene Examination Glove
Indications For Use:
ুটি নিয়ে যাচ্ছে বাংলাদেশ করে তার প্রায় প্রতিষ্ঠান করে তার প্রকল্পিত হয়েছে। এরপর প্রতি প্রকল্পিত হয়েছে তার প্রকল্পিত হয়েছে তার প্রকল্প করে তার প্রকল্প করে তার প্রকল্প করে পার
The Synthalon® PI Powder-free Synthetic Polyisoprene/Polychloroprene 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
P
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule. M. Murphy 4/21/06
- For a new submission, do NOT fill in the 510(k) number.
BarrierMed Glove Co.
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