(35 days)
Not Found
Not Found
No
The document describes standard examination gloves and contains no mention of AI or ML technology.
No
The device, "patient examination gloves", is intended for preventing contamination, not for treating or diagnosing a medical condition.
No
Explanation: The device is described as an examination glove intended to prevent contamination, not to diagnose any condition.
No
The device description clearly states it is a physical product (gloves) and does not mention any software 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 hands or fingers to prevent contamination between patient and examiner. This is a physical barrier device used for infection control.
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This glove does not perform any such test.
- Lack of IVD-related information: The description does not mention any testing, analysis of biological samples, or diagnostic purposes.
Therefore, the device described is a medical device, specifically a Class I medical device (as indicated by the 21CFR 880.6250 reference), but it is not an IVD.
N/A
Intended Use / Indications for Use
A patient examination gloves is a disposable device intended for medical purposes that is worn A pattent examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Powder Free Butadiene Exam Gloves with Aloe, Green Color
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
medical purposes
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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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 consists of a stylized caduceus symbol, which features three curved lines representing the human form. The symbol is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in capital letters. The text is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 0 2005
Ms. Cynthia Liu Service Marketing Manager Shen Wei (USA) Incorporated 2845 Whipple Road Union City, California 94587
Re: K050467
Trade/Device Name: Powder Free Butadiene Exam Gloves with Aloe, Green Color Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LZA Dated: February 21, 2005 Received: February 23, 2005
Dear Ms. Liu:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowed your and have determined the device is substantially equivalent (for the inclications 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 cither 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 Eederal Register.
1
Page 2 - Ms. Liu
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 moall that I DAT mas made a statutes and regulations administered by other Federal agencies. of the Act of ally I oderal backed s requirements, including, but not limited to: registration 1 out intist contiply with and the labeling (21 CFR Part 801); good manufacturing practice aller listing (21 CF R Part 807), abolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality ajon 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 letter will anow Jourse FDA finding of substantial equivalence of your device to a premiarket notification. The PDF mixtis 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), If you desire specific at not 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 obtain 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,
Chiu Lin, Ph.D.
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
Attachment Two - R
INDICATION FOR USE
510(k) Number (if known): K050467
Powder Free Butadiene Exam Gloves with Aloe, Green Color Device Name:
Indication for Use:
A patient examination gloves is a disposable device intended for medical purposes that is worn A pattent examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
Prescription Use (Per 21CFR 801 Subpart D) AND/OR
Over the Counter______________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH Office of Device Evaluation (ODE)
Shula H. Murphy D 5/30/05
sion Sion-Off sion of Anesthesiology, General Hospital, tection Control, Dental De
Number: K 0504167