(31 days)
QTEXX Powder free Latex 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 Powder Free Latex Examination Gloves, Polymer-coated meet the current specification listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves, They are natural white in colour and are powder free.
The provided text is related to a 510(k) submission for QTEXX Powder Free Latex Examination Gloves. This device is a medical glove, and the acceptance criteria and study design described are for demonstrating its physical and biocompatibility properties, rather than diagnostic performance metrics typically associated with AI/ML devices. As such, many of the requested fields (e.g., effect size of human readers, training set details) are not applicable.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D 3578-95, Standard Specification for Rubber Examination Gloves | QTEXX Powder Free Latex Examination Gloves meet all the current specifications listed under ASTM D 3578-95. |
| 21 CFR 800.20 (Quality System Regulation for Medical Devices) | Gloves meet all current specifications listed under ASTM D 3578-95 and 21 CFR 800.20. |
| Primary skin irritation (rabbit) | Indicates no irritation. |
| Delayed contact sensitization (guinea pig) | Indicates no sensitization. |
| Presence of starch (USP iodine test) | Final product is negative for the presence of starch. |
| Total Water Extractable Protein (for protein label claim) | 50 micrograms or less of Total Water Extractable Protein per gram. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test performed under ASTM D 3578-95 or for the biocompatibility tests (skin irritation, sensitization). However, the tests are performed on the device itself.
- Data Provenance: The tests were conducted by the manufacturer, Latexx Partners Berhad, based in Malaysia. The testing is non-clinical/bench testing and animal studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is a physical medical glove and not an AI/ML imaging device that requires expert ground truth for diagnostic accuracy. The "ground truth" for these tests comes from established international standards (ASTM) and regulatory requirements (21 CFR). Biocompatibility tests are performed on animals.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements against established physical and chemical standards, and animal responses to the material. No human adjudication of diagnostic output is involved.
5. 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. This is not an AI/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML diagnostic device.
7. The type of ground truth used
The ground truth used for this device's performance validation is a combination of:
- Standard Specifications: ASTM (American Society for Testing and Materials) D 3578-95 for physical properties (e.g., tensile strength, elongation, barrier integrity).
- Regulatory Requirements: 21 CFR 800.20 for general medical device quality.
- Biocompatibility Testing: In vivo animal studies (rabbits for skin irritation, guinea pigs for sensitization) for biological safety.
- Chemical Testing: USP iodine test for starch presence, and methods for determining total water extractable protein.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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MAY 28 1920
11.1
- 中国电视
510(k) SUMMARY
1462 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 : | April 15, 1999 |
| Name of Device : | QTEXX POWDER FREE LATEX |
| Trade Name : | EXAMINATION GLOVES, POLYMER-COATED |
| Common Name : | Latex examination gloves |
| Classification Name : | Patient Examination Gloves |
| Legally Marketed Device to WhichEquivalency is Being Claimed : | QTEXX Powder Free Latex Examination Gloves,Polymer-coated as described in the 510(k)notification are substantially equivalent to theClass 1 patient examination glove 80LYY. Itmeets all the current specifications listed underthe ASTM Specification D 3578 - 95, StandardSpecification for Rubber Examination Gloves. |
| Description of the Device : | QTEXX Powder Free Latex ExaminationGloves, Polymer-coated meet the currentspecification listed under the ASTM SpecificationD 3578 - 95, Standard Specification for RubberExamination Gloves, They are natural white incolour and are powder free. |
| Intended Use of the Device: | QTEXX Powder Free Latex Examination Glovesare intended for single use for medical purposesthat is worn on the hand of health care and similarpersonnel to prevent contamination between thehealth care personnel and the patients. |
| Summary of TechnologicalCharacteristics Compared to the PredicateDevice : | There is no difference in technologicalcharacteristics. Gloves are made from naturalrubber compound and the initial products arepowdered natural rubber gloves. These gloves arethen further processed into powder free glovesusing the existing technology, i.e. washing andthen chlorinating the surfaces of the gloves. |
| Brief Discussion of Nonclinical Tests : | Testing performed as per ASTM D 3578-95 and21 CFR 800.20. Gloves meet all the currentspecifications listed under the ASTMSpecification D 3578-95, 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 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. |
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 28 1999
Mr. Chong Eng Lim General Manaqer Latexx Partners Bhd. PT 5054, Kamunting Industrial Estate P.O. Box 9 34600 Kamunting, Taiping, Perak, MALAYSIA
Re: K991462 QTEXX Powder-Free Latex Examination Gloves, Trade Name: Polymer Coated,Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram Regulatory Class: I Product Code: LYY Dated: April 15, 1999 April 27, 1999 Received:
Dear Mr. Chong Eng 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 aqainst 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 Requlations, Title 21, Parts 800 to 895. ਉ 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 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.
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Page 2 - Mr. Chong Eng Lim
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 requlation (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 one regaration cronson" (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,
Susan Punover
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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INDICATIONS FOR USE
Applicant
11/10
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LATEXX PARTNERS BERHAD PT 5054, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAYSIA
510(k) Number
(if known)
K991462 美
Device Name
QTEXX POWDER FREE LATEX EXAMINATION GLOVES POLYMER-COATED (PROTEIN LABEL CLAIM) 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM.
Indications For Use :
QTEXX Powder free Latex 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)
Olin S. Lin
(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
§ 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.