(41 days)
Not Found
None
No
The 510(k) summary describes a standard medical examination glove and contains no mention of AI or ML technology.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
The device is described as a "patient examination glove" intended to prevent contamination between the patient and examiner. This function is protective and does not involve diagnosing medical conditions.
No
The device description clearly states it is a physical product (Patient Vinyl Examination Gloves) and does not mention any software component.
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 hands to prevent contamination between patient and examiner. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description confirms it's a "Patient Vinyl Examination Gloves," which are physical barriers.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic purposes. This glove does not perform such a function.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Product codes
LYZ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands 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)
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
DEPARTMENT OF HEALTH & HUMAN SERVICES-USA
APR - 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zibo Blue INTCO Plastic & Rubber Products Company Limited C/O Ms. Karen Abell Official Correspondent Basic Medical Industries, Incorporated 12390 East End Avenue Chino, California 91710
Re: K050450
.
Trade/Device Name: Patient Vinyl Examination Gloves, Powderfree, Non-Sterile Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: January 15, 2005 Received: February 23, 2005
Dear Ms. Abell:
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 mendments, or to devices that have been reclassified in accordance with the provisions of / Innonements, or to we we cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls province 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 (1 Nr.), it may of cashed 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 - Ms. Abell
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 moun that I Dr may Federal statutes and regulations administered by other Federal agencies. of the For of all - Four all the Act's requirements, including, but not limited to: registration r ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 es read on the quality systems (QS) regulation (21 CFR Part 820); and if requirements as betrenir 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) I mis lotor will and n yourse of substantial equivalence of your device to a premaired predicated. - I a 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), r you deems of 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 may overn 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,
Cure
Chiu 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
Zibo Blue INTCO Plastic & Rubber Products Co., Ltd. Qilu Chmical Industrial Area Zibo, Shandong China 255414
INDICATIONS FOR USE
Zibo Blue INTCO Plastic & Rubber Products Co., LTD Applicant:
K050450 510(k) Number:
Device Name:
Patient Vinyl Examination Gloves, Powderfree, Non-Sterile
Indications of Use:
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Prescription Use
Over the Counter Use X
Factory Initials wff
あるときていましたときになるところです。そうでするときになっていた
Judy L. Humphrey, D
Anston Sign-Off) Asion of Anesthesiology, General Hospital, rection Control, Dental Devices
) Number: 150452