(21 days)
Not Found
Not Found
No
The device description is for examination gloves, which are a physical barrier and do not involve any computational or analytical functions. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is described as an examination glove intended to prevent contamination, which serves a protective and barrier function, not a therapeutic one.
No
Explanation: The device is described as a "patient examination glove" intended to prevent contamination between a patient and an examiner. It does not perform any diagnostic function such as identifying, treating, or preventing disease, injury, or other conditions.
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 is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the material and construction of a glove, which is a physical barrier device.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / Indications for Use
A patient examination gloves 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
Powder-Free Multi-Ply Latex Examination Gloves, Polymer Coated on Outside and Nitrile Coated Inside, Blue Color with Protein Labeling Claim 50 Micrograms or Less of Total Extractable Protein
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 (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 & Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 2001
K. Karunakaran Mr. Quality Assurance Manager PWA Industries Sdn. Bhd. Lot 93, Kawasan Perindustrain Semambu 25350 Kuantan, Pahang, MALAYSIA
Re : K011895 Trade/Device Name: Powder-Free Multi-Ply Latex Examination Gloves, Polymer Coated on Outside and Nitrile Coated Inside, Blue Color with Protein Labeling Claim 50 Micrograms or Less of Total Extractable Protein Regulation Number: 880.6250 Regulatory Class: I Product Code: LYY Dated: June 14, 2001 Received: June 18, 2001
Dear Mr. Karunakaran:
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 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 acvices chare federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major be bublede to back addroundevice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug
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Page 2 - Mr. Karunakaran
Administration (FDA) will verify such assumptions. Failure to Admiliberation (CMP regulation may result in regulatory In addition, FDA may publish further announcements action.
concerning your device in the Federal Register. Please note: concerning your device in arranket notification submission does chis response or four for you might have under sections 531 not arrough 542 of the Act for devices under the Electronic emoduct Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your sia equivalence of your device to a legally rinding of bubbandar of results in a classification for your markets produce, 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 ritro 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/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
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INDICATION FOR USE
Applicant: PWA INDUSTRIES SDN.BHD. 510(k) Number (if known): --------------------------------------------------------------------------------------------------------------------------
DEVICE NAME: Powder-free Multi-ply Latex Examination Gloves, Polymer Coated on the Outside and Nitrile Coated on the Inside (Blue Color). With Protein Labeling claim 50ug/g or less of total extractable protein content.
INDICATIONS FOR USE:
A patient examination gloves 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 --
(Optional Format 1-2-95)
Clins. Lin
(Division Sign-Off) Division of Dental, Infection Cor and General Hospit 510/k) Number