(67 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the QTEXX Non-Chlorinated, Powder Free Nitrile Examination Gloves, Polymer-Coated, based on the provided document:
This document is a 510(k) submission for a medical device (nitrile examination gloves) and primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics for an AI/algorithm-driven device.
Therefore, many of the requested categories (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, direct effect sizes for AI improvement) are not applicable to this type of regulatory submission for a physical medical glove. The "device" in this context is the glove itself, not an AI or software algorithm.
However, I can extract the relevant information regarding performance criteria and the studies conducted to meet them as presented in the document.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (based on ASTM D 3578-99 and 21 CFR 800.20) | Reported Device Performance | Study Type |
|---|---|---|---|
| Physical Properties | Meets all current specifications listed under ASTM Specification D 3578-99, Standard Specification for Rubber Examination Gloves for Medical Applications. | Gloves meet all current specifications listed under ASTM D 3578-99. | Nonclinical Testing |
| Biocompatibility | No irritation in primary skin irritation testing in rabbits. | Indicate no irritation. | Nonclinical Testing (Animal Study) |
| No sensitization in delayed contact sensitization testing in guinea pigs. | Indicate no sensitization. | Nonclinical Testing (Animal Study) | |
| Powder-Free Status | Negative for the presence of starch using the USP iodine test. | Negative for the presence of starch. | Nonclinical Testing |
Note: The document states that the device is "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". The table above extracts the implicit and explicit criteria mentioned.
Study Details (as applicable to a physical medical device)
-
Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes used for the nonclinical tests (e.g., how many gloves were tested for physical properties, how many rabbits/guinea pigs were used). This level of detail is typically found in the full study reports, not the summary K992924 submission.
- Data Provenance: The origin of the data is from testing conducted by the manufacturer, Latexx Partners Berhad, likely in Malaysia, to meet U.S. regulatory standards (ASTM and FDA). This would be considered prospective testing specifically for this device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This question typically pertains to studies involving human interpretation (e.g., medical imaging, clinical assessments) where expert consensus establishes a "ground truth" for an algorithm. For physical device testing like gloves, "ground truth" is established by standard laboratory measurements and observations against predefined criteria.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this is for clinical interpretation studies. Laboratory testing results are typically directly measured and compared to specifications.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. No MRMC study was conducted or is relevant for this physical device. This question applies to AI-assisted diagnostic or interpretive tasks.
-
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not Applicable. This applies to AI/software performance. The performance described here is for the physical glove itself.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Objective Measurement against Standards: The "ground truth" for the physical properties of the gloves (e.g., dimensions, tensile strength, freedom from holes) is defined by the ASTM D 3578-99 standard specifications.
- Observed Biological Response: For biocompatibility, the "ground truth" is the observed biological response (lack of irritation or sensitization) in the animal models, as per established toxicology testing protocols.
- Chemical Reaction: For powder-free status, the "ground truth" is the absence of a positive chemical reaction (USP iodine test).
-
The sample size for the training set:
- Not Applicable. This question refers to machine learning algorithms. The manufacturing process of the gloves might involve internal quality control data, but there is no "training set" in the AI sense for establishing the glove's core performance.
-
How the ground truth for the training set was established:
- Not Applicable. As per point 7.
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QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER - COATED
| Submitter's Name : | LATEXX PARTNERS BERHAD |
|---|---|
| Submitter's Address : | PT 5054, Kamunting Industrial EstateP.O. Box 934600 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, POWDERFREE NITRILE EXAMINATION GLOVES,POLYMER - COATED |
| Trade Name : | Nitrile examination gloves |
| Common Name : | Patient Examination Gloves |
| Classification Name : | QTEXX, Non -- Chlorinated , Powder Free NitrileExamination Gloves, Polymer-coated asdescribed in the 510(k) notification aresubstantially equivalent to the Class 1 patientexamination glove 80LZA. It meets all thecurrent specifications listed under the ASTMSpecification D 3578 – 99, Standard Specificationfor Rubber Examination Gloves |
| Legally Marketed Device to WhichEquivalency is Being Claimed : |
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| Description of the Device : | QTEXX, Non - Chlorinated, Powder Free NitrileExamination Gloves, Polymer-coated meet thecurrent specification listed under the ASTMSpecification D 3578 – 99, Standard Specificationfor Rubber Examination Gloves, They are blue ornatural white in colour and are powder free. |
|---|---|
| Intended Use of the Device: | QTEXX, Non - Chlorinated, Powder Free NitrileExamination Gloves are intended for single usefor medical purposes that is worn on the hand ofhealth care and similar personnel to preventcontamination between the health care personneland the patients. |
| Summary of TechnologicalCharacteristics Compared to the PredicateDevice : | There is no difference in technologicalcharacteristics. Gloves are made from nitrilerubber compound and the initial products arepowder free nitrile gloves. The powder free nitrilegloves are produced on – line without furtherchlorination process. No powder is used as mouldrelease agent, but rubber resin coating is used aspolymer coating material. |
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| Brief Discussion of Nonclinical Tests : | Testing performed as per ASTM D 3578 - 99 and21 CFR 800.20. Gloves meet all the currentspecifications listed under the ASTMSpecification D 3578 -99, Standard Specificationfor Rubber Examination Gloves for MedicalApplication.Primary skin irritation testing in the rabbit anddelayed contact sensitization testing in the guineapig indicate no irritation of sensitization.Final product is negative for the presence ofstarch using the USP iodine test. |
|---|---|
| Brief Discussion of Clinical Tests : | No new clinical tests were conducted under this510(k). |
| Conclusions Drawn for the Nonclinicaland Clinical Tests : | Nonclinical laboratory and animal data indicatethat the powder free product meets allperformance and bio-compatibility requirements. |
| Other Information Deemed Necessary byFDA : | Not applicable. |
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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
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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
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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
§ 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.