(23 days)
Not Found
Not Found
No
The device description and performance studies focus on material properties and standard glove testing, with no mention of AI or ML.
No
The device, a latex examination glove, is intended to prevent contamination and is classified as a Class 1 patient examination glove. It does not provide any therapeutic benefit to the patient.
No
This device, a glove, is intended for barrier protection, preventing contamination between personnel and patients. Its purpose is not to diagnose medical conditions or diseases.
No
The device is a physical examination glove, which is a hardware medical device, not software. The description focuses on material properties and performance testing of the glove itself.
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 "single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and standards met by the glove (ASTM D 3578-95).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
- Predicate Device: The predicate device is listed as a "Class 1 patient examination glove," which is consistent with a barrier device, not an IVD.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide information about a person's health status. This glove does not perform such a function.
N/A
Intended Use / Indications for Use
QTEXX Powder Free Latex Examination Gloves are intended for single use for medical purposes and are worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patients.
Product codes
LYY
Device Description
QTEXX Powder Free Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves. They are natural white in colour and are powder free.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care and similar personnel
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
Testing is performed as per ASTM D 3578-95 and 21 CFR 800.20. Gloves meet all the current specifications listed under the ASTM Specification D 3578 – 95, Standard Specification for Rubber Examination Gloves.
Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig indicate no irritation or sensitization.
Final product is negative for the test for presence of starch using the USP iodine test.
No new clinical tests were conducted under this 510(k).
Nonclinical laboratory and animal data indicate that the powder free product meets all performance and biocompatability requirements.
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
QTEXX POWDER FREE LATEX EXAMINATION GLOVES
JUN 1 1 1998 Latex Partners Bhd. Submitter's Name : PT 5054, Kamunting Industrial Estate Submitter's Address : 34600 Taiping Perak Malaysia 605 891 2555 Submitter's Phone Number 605 891 2688 Submitter 's Fax Number : Goh, See Khek Name of Contact Person : May 12, 1998 Date of Preparation : Name of Device : QTEXX POWDER FREE LATEX Trade Name : EXAMINATION GLOVES Latex examination gloves Common Name : Patient Examination Gloves Classification Name : QTEXX Powder Free Latex Examination Gloves Legally Marketed Device to Which as described in the 510(k) notification are Equivalency is Being Claimed : substantially equivalent to the Class 1 patient examination glove 80LYY. It meets all the current specifications listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves. QTEXX Powder Free Latex Examination Gloves Description of the Device : meet the current specifications listed under the i ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves. They are natural white in colour and are powder free.
1
| K981767 | |
|---|---|
| Intended Use of the Device: | QTEXX Powder Free Latex Examination Gloves are intended for single use for medical purposes and are worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patients. |
| Summary of Technological | |
| Characteristics Compared to the Predicate | |
| Device : | There are no different technological characteristics. Gloves are made from natural rubber compound and the initial products are powdered natural latex examination gloves. These gloves are then further processed into powder free gloves using the existing technology, i.e. chlorinating and then washing the surfaces of the gloves. |
| Brief Discussion of Nonclinical Tests : | Testing is performed as per ASTM D 3578-95 and 21 CFR 800.20. Gloves meet all the current specifications listed under the ASTM Specification D 3578 – 95, Standard Specification for Rubber Examination Gloves. |
Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig indicate no irritation or sensitization.
Final product is negative for the test for presence of starch using the USP iodine test. |
| Brief Discussion of Clinical Tests : | No new clinical tests were conducted under this 510(k). |
| Conclusions Drawn for the Nonclinical
and Clinical Tests : | Nonclinical laboratory and animal data indicate that the powder free product meets all performance and biocompatability requirements. |
| Other Information Deemed Necessary by
FDA : | Not applicable |
ﺍﻟﻤﺴﺘﻮﻯ
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 1998
Mr. Goh See Knek •Latexx Partners Berhad PT 5054, Kamunting Industrial Estate 34600 Taiping Perak MALAYSIA
Re: K981767 Qtexx Powder-Free Latex Examination Gloves Trade Name: with 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulatory Class: I Product Code: LYY Dated: May 14, 1998 Received: May 19, 1998
Dear Mr. Goh See Knek:
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 provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual reqistration, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Reqister. this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Mr. Goh See Khek
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro 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 requlation 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 ____________________________________________________________________________________________________________________________________________________________________
4
INDICATIONS FOR USE
Applicant
LATEXX PARTNERS BHD. PT 5054, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAYSIA
510(k) Number (if known)
981767 *
Device Name
QTEXX POWDERFREE LATEX EXAMINATION GLOVE (PROTEIN LABEL CLAIM) 50 mg m or
Indications For Use
QTEXX Powderfree Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Clim S. Lim
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use Per 21 CFR 801.109 OR Over-The-Counter