(67 days)
Not Found
Not Found
No
The device is a medical glove, and the description focuses on material properties and performance standards, with no mention of AI or ML.
No
The device is described as an examination glove intended to prevent contamination, not to treat a condition or disease.
No
Explanation: The device is described as an examination glove intended to prevent contamination, not to diagnose a medical condition.
No
The device is a physical examination glove, not a software application. The description focuses on material properties and performance testing of a tangible product.
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 glove worn on the hand to prevent contamination between healthcare personnel and the patient. This is a barrier device, not a diagnostic tool used to examine specimens from the human body.
- Device Description: The description focuses on the physical properties and standards met by the glove (ASTM D 3578-99). There is no mention of any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document 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 treatment decisions based on sample analysis.
Therefore, the QTEXX glove is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
QTEXX, Non - Chlorinated Powder free Nitrile Examination Glove, polymer-coated 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
QTEXX, Non - Chlorinated, Powder Free Nitrile Examination Gloves, Polymer-coated meet the current specification listed under the ASTM Specification D 3578 – 99, Standard Specification for Rubber Examination Gloves, They are blue or 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing performed as per ASTM D 3578 - 99 and 21 CFR 800.20. Gloves meet all the current specifications listed under the ASTM Specification D 3578 -99, Standard Specification for Rubber Examination Gloves for Medical Application.
Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig indicate no irritation of sensitization.
Final product is negative for the presence of starch using the USP iodine test.
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
.
QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER - COATED
| Submitter's Name : | LATEXX PARTNERS BERHAD |
|---|---|
| Submitter's Address : | PT 5054, Kamunting Industrial Estate |
| P.O. Box 9 | |
| 34600 Kamunting, Perak, | |
| Malaysia. | |
| Submitter's Phone Number | 605 8915555 |
| Submitter 's Fax Number : | 605 8912688 |
| Name of Contact Person : | Lim, Chong Eng |
| Date of Preparation : | October 11, 1999 |
| Name of Device : | QTEXX, NON- CHLORINATED, POWDER |
| FREE NITRILE EXAMINATION GLOVES, | |
| POLYMER - COATED | |
| Trade Name : | Nitrile examination gloves |
| Common Name : | Patient Examination Gloves |
| Classification Name : | QTEXX, Non -- Chlorinated , Powder Free Nitrile |
| Examination Gloves, Polymer-coated as | |
| described in the 510(k) notification are | |
| substantially equivalent to the Class 1 patient | |
| examination glove 80LZA. It meets all the | |
| current specifications listed under the ASTM | |
| Specification D 3578 – 99, Standard Specification | |
| for Rubber Examination Gloves | |
| Legally Marketed Device to Which | |
| Equivalency is Being Claimed : |
1
| Description of the Device : | QTEXX, Non - Chlorinated, Powder Free Nitrile
Examination Gloves, Polymer-coated meet the
current specification listed under the ASTM
Specification D 3578 – 99, Standard Specification
for Rubber Examination Gloves, They are blue or
natural white in colour and are powder free. |
|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use of the Device: | QTEXX, Non - Chlorinated, Powder Free Nitrile
Examination Gloves are intended for single use
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 patients. |
| Summary of Technological
Characteristics Compared to the Predicate
Device : | There is no difference in technological
characteristics. Gloves are made from nitrile
rubber compound and the initial products are
powder free nitrile gloves. The powder free nitrile
gloves are produced on – line without further
chlorination process. No powder is used as mould
release agent, but rubber resin coating is used as
polymer coating material. |
2
| Brief Discussion of Nonclinical Tests : | Testing performed as per ASTM D 3578 - 99 and
21 CFR 800.20. Gloves meet all the current
specifications listed under the ASTM
Specification D 3578 -99, Standard Specification
for Rubber Examination Gloves for Medical
Application.
Primary skin irritation testing in the rabbit and
delayed contact sensitization testing in the guinea
pig indicate no irritation of sensitization.
Final product is negative for the 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 bio-compatibility requirements. |
| Other Information Deemed Necessary by
FDA : | Not applicable. |
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 1999
Mr. C.E. Lim General Manaqer Latexx Partners Berhad PT 5054, Kamunting Industrial Estate P.O. Box 9, 34600 Kamuntinq Taiping, Perak, Malaysia
Re : K992924 Trade Name: Non-Chlorinated, Powder Free Nitrile Exam Gloves, Polymer Coated, Blue Regulatory Class: I Product Code: LZA Dated: October 11, 1999 Received: October 14, 1999
Dear Mr Lim:
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 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 controls provisions The general controls provisions of the Act 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
4
Page 2 - Mr. Lim
obligation you might have under sections 531 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/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
5
Attachment 2
INDICATIONS FOR USE
Applicant
LATEXX PARTNERS BERHAD PT 5054, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAYSIA
510(k) Number (if known)
K992924 *
Device Name
Stirt QTEXX, NON- CHLORINATED, NITRILE POWDER FREE EXAMINATION GLOVES POLYMER-COATED
Indications For Use :
OTEXX. Non - Chlorinated Powder free Nitrile Examination Glove, polymer-coated 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)
AB dr Olivi
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_Kgg 2924
Prescription Use Per 21 CFR 801.109
Over-The-Counter OR