(35 days)
Powder Free Nitrile Rubber Examination Glove, Green Colour, is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Medtexx™ Powder Free Green Colour Nitrile Rubber Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from nitrile rubber latex compound. They are natural white in color and are powder free.
The provided document is a 510(k) summary for "POWDER FREE GREEN COLOUR NITRILE RUBBER EXAMINATION GLOVES". It describes the device, its intended use, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ASTM D 6319-00a for Nitrile Examination Gloves) | Reported Device Performance |
|---|---|
| Visual Inspection for flaws (e.g., holes, tears, embedded foreign objects, physical dimensions) | Not explicitly detailed, but implied to meet "all the current specifications" |
| Physical Properties (e.g., tensile strength, elongation at break, force at break) | Not explicitly detailed, but implied to meet "all the current specifications" |
| Freedom from holes (e.g., Water Leak Test) | Not explicitly detailed, but implied to meet "all the current specifications" |
| Protein Content (for latex gloves, not directly applicable to nitrile but a general consideration for glove safety) | Not applicable, as this is a nitrile glove. |
| Powder content (for powder-free gloves) | Final product is negative for the presence of starch using the USP iodine test. Implied to meet powder-free requirements. |
| Primary skin irritation | No irritation indicated by testing in rabbits. |
| Delayed contact sensitization | No sensitization indicated by testing in guinea pigs. |
| Biocompatibility requirements (general) | Met “all performance and biocompatibility requirements.” |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. The statement "Testing performed per ASTM D 6319 - 00a" implies that appropriate sample sizes as dictated by the standard were used, but the specific numbers are not mentioned.
- Data Provenance: The document states "Testing performed per ASTM D 6319 - 00a" and refers to "laboratory and animal based test data." This indicates the tests were conducted in a controlled environment (laboratory) and involved animal subjects (rabbits and guinea pigs), likely conducted by the manufacturer or a contracted lab. The country of origin of the data is not explicitly stated, but the manufacturer is based in Malaysia. These were non-clinical (pre-market) tests, which are typically prospective in nature for a new device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device and study. The "ground truth" for examination gloves is established by objective engineering and biocompatibility standards (ASTM D 6319-00a and 21 CFR 800.20), not by expert consensus in interpreting images or clinical outcomes.
4. Adjudication method for the test set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies where human interpretation of medical data is being evaluated, typically for diagnostic devices. For examination gloves, performance is measured against objective standards.
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:
This information is not applicable. An MRMC study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is an examination glove, which does not involve human interpretation or AI assistance in its function.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. "Standalone" performance generally refers to the performance of an AI algorithm independent of human interaction. Since this device is an examination glove, it does not involve any algorithms.
7. The type of ground truth used:
- The ground truth used is based on established industry standards and regulatory requirements.
- ASTM Specification D 6319-00a: This standard defines the physical requirements (e.g., dimensions, tensile strength, elongation, freedom from holes) for nitrile examination gloves. The device's performance against these specifications serves as the factual "ground truth" for its physical properties.
- 21 CFR 800.20: This refers to the FDA's biocompatibility requirements for medical devices. The results from primary skin irritation and delayed contact sensitization tests against these requirements form the biocompatibility "ground truth."
- USP iodine test: Used to confirm the absence of starch, which is the "ground truth" for being "powder-free."
8. The sample size for the training set:
This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical product (examination glove) and does not involve machine learning or AI.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set for this device.
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510(k) SUMMARY
POWDER FREE GREEN COLOUR NITRILE RUBBER EXAMINATION GLOVES
| Submitter's Name | LATEXX MANUFACTURING SDN. BHD. |
|---|---|
| Submitter's Address | PT 5054, Kamunting Industrial EstateP.O. Box 9, 34600 Taiping, PerakMalaysia |
| Submitter's Phone Number | 605 891 1111 |
| Submitter 's Fax Number | 605 891 1088 |
| Name of Contact Person | Teoh, Choh Shee |
| Date of Preparation | June 15, 2002 |
| Name of Device | |
| Trade Name | : Medtexx™ Powder Free Green Colour Nitrile RubberExamination Glove |
| Common Name | : Nitrile Rubber Examination Gloves |
| FDA SE Classification Name | : Patient Examination Gloves, Powder-free |
| FDA Classification Product Code | : Nitrile - 80LZA |
| Legally Marketed Device to Which Equivalencyis Being Claimed | : Medtexx™ Powder Free Green Colour Nitrile RubberExamination Glove as described in this 510k Notification issubstantially equivalent to the current Class I patientexamination glove bearing the product code 80LZA(21CFR 880.6250). It meets all the current specificationslisted under the ASTM Specification D 6319-00a, StandardSpecification for Nitrile Examination Gloves for MedicalApplication. |
| Description of the Device | : Medtexx™ Powder Free Green Colour Nitrile RubberExamination Glove meets all the current specificationslisted under the ASTM Specification D 6319-00, StandardSpecification for Nitrile Examination Gloves for MedicalApplication. They are made from nitrile rubber latexcompound. They are natural white in color and are powderfree. |
| Intended Use of the Device | Medtexx™ Powder Free Green Colour Nitrile RubberExamination Glove is intended for single use for medicalpurposes that is worn on the hand of health care andsimilar personnel to prevent contamination between thehealth care personnel and the patients. |
| Summary of Technological CharacteristicsCompared to the Predicate Device | There is no different technological characteristic. Glovesare made from nitrile rubber latex compound and the initialproducts are low powdered nitrile gloves. These gloves arethen further processed into powder free gloves using theexisting technology, i.e. chlorination and multiple washingand rinsing processes. |
| Brief Description of Non-clinical Tests | Testing performed per ASTM D 6319 - 00a, StandardSpecification for Nitrile Examination Gloves for MedicalApplication and 21 CFR 800.20. Gloves meet all thecurrent ASTM D 6319-00a.Primary skin irritation testing in the rabbit and delayedcontact sensitization testing in the guinea pig indicate noirritation or sensitization.Final product is negative for the presence of starch usingthe USP iodine test. |
| Brief Description of Clinical Tests | No new clinical tests were conducted under this 510(k). |
| Conclusions Drawn from the Non-clinical andClinical Tests | Non-clinical laboratory and animal based test data indicatethat the powder-free product meets all performance andbiocompatibility requirements. |
| Other Information Deemed Necessary by FDA | Not applicable. |
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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, resembling a bird-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 02 2002
Latexx Manufacturing Sdn. Bhd. C/O Mr. Law Siau Woei Medtexx Partners Incorporated 216 Charles Street Hackensack, New Jersey 07601
Re: K022101
Trade/Device Name: Powder Free Nitrile Rubber Examination Glove, Green Color Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: June 15, 2002 Received: June 28, 2002
Dear Mr. Woei:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 - Mr. Woei
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runnes
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Medtexx™ Green Colour Powder-free Nitrile Rubber Examination Gloves
Image /page/4/Picture/2 description: The image shows a logo for Latex Manufacturing SDN BHD. The logo features the word "LATEX" in bold, stylized letters, with the "X" extending downwards. Above and to the right of the "X" is a circular design with several vertical lines inside. Below the word "LATEX" are the words "MANUFACTURING SDN BHD" and the number "(165989-U)".
INDICATIONS FOR USE
LATEXX MANUFACTURING SDN.BHD. Applicant : PT 5054, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAYSIA
K022101 510(k) Number : (if known)
POWDER FREE NITRILE RUBBER Device Name : EXAMINATION GLOVE, GREEN COLOUR.
Indications For Use :
Powder Free Nitrile Rubber Examination Glove, Green Colour, is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Concurrence of CDRH Office of Device Evaluation (ODE)
Qim S. lin
(Division Sign-Off) (Division Sign-Ont)
Division of Dental, Infection Control, Divisioneral Hospital, D r » Allimber
§ 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.