(14 days)
Blue Colour Powder Free Nitrile Rubber Examination Gloves 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™ Blue Colour Powder Free Nitrile Rubber Examination Glove is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY (21CFR 880.6250). It meets all the current specifications listed under the ASTM Specification D 6913-00a, Standard Specification for Nitrile Examination Gloves. They are made from nitrile rubber compound. They are blue in color and are powder free.
The provided document describes the acceptance criteria and the study conducted for the Medtexx™ Blue Colour Powder Free Nitrile Rubber Examination Gloves.
Here's the breakdown:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (ASTM D 6319-00a) | Reported Device Performance (Medtexx™ Gloves) |
|---|---|---|
| Physical Properties | Meets ASTM D 6319-00a specifications | Meets ASTM D 6319-00a specifications |
| Biocompatibility | No irritation or sensitization | Negative for primary skin irritation and delayed contact sensitization |
| Powder-Free (Starch Presence) | Negative for starch | Negative for the presence of starch (USP iodine test) |
Note: The document states that the device "meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves" and "Non-clinical laboratory and animal based test data indicate that the powder-free product meets all performance and biocompatibility requirements." However, specific numerical values for physical properties (e.g., tensile strength, elongation, force at break, freedom from holes) are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not explicitly state the sample size used for each specific test within ASTM D 6319-00a. However, it indicates testing was performed per ASTM D 6319-00a. This standard specifies sampling plans for various tests (e.g., visual inspection for defects, physical dimensions, physical properties, leak test).
- Data Provenance:
- Country of Origin: The test origin is not explicitly stated, but the submitter (Latexx Manufacturing Sdn. Bhd.) is based in Malaysia.
- Retrospective or Prospective: The testing described for this 510(k) is prospective, as it was conducted to demonstrate substantial equivalence for the new device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the evaluation of examination gloves. The "ground truth" for examination gloves is established through adherence to recognized international standards (ASTM D 6319-00a) for physical properties and validated laboratory test methods for biocompatibility and chemical composition. There are no human "experts" in the sense of medical diagnosticians establishing interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The assessment involves physical, chemical, and biological testing against predefined scientific criteria, not subjective human interpretation requiring adjudication.
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 is not applicable. The device is a medical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The phrase "standalone performance" typically refers to the performance of an AI algorithm. This device is a physical product (medical glove) and its performance is evaluated through laboratory and preclinical (animal) tests, not algorithmic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by:
- Accredited laboratory testing and adherence to published, universally accepted industry standards: Specifically, ASTM D 6319-00a for Nitrile Examination Gloves. This standard dictates test methods and acceptable limits for properties like dimensions, physical characteristics (tensile strength, elongation), and freedom from holes.
- Established biological testing protocols: For biocompatibility (primary skin irritation and delayed contact sensitization), validated animal models are used as the ground truth.
- Standardized chemical tests: For powder-free claims, a USP iodine test for starch is used.
8. The sample size for the training set
This is not applicable. The device is a manufactured product, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this device.
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AUG 1 5 2002
510(k) SUMMARY
Y022548
MEDTEXX™ BLUE COLOUR POWDER FREE
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 | July 30, 2002 |
| Name of Device | |
| Trade Name | Medtexx™ Blue Colour Powder Free Nitrile RubberExamination Glove |
| Common Name | Synthetic Rubber Examination Gloves |
| Classification Name | Patient Examination Gloves |
| Legally Marketed Device to WhichEquivalency is Being Claimed | Medtexx™ Blue Colour Powder Free Nitrile RubberExamination Glove as described in this 510k Notification issubstantially equivalent to the current Class I patientexamination glove bearing the product code 80LZA (21CFR880.6250). It meets all the current specifications listed underthe ASTM Specification D 6913-00a, Standard Specificationfor Nitrile Examination Gloves. |
| Description of the Device | Medtexx™ Blue Colour Powder Free Nitrile RubberExamination Glove is substantially equivalent to the Class 1patient examination glove bearing the product code 80LYY(21CFR 880.6250). It meets all the current specificationslisted under the ASTM Specification D 6913-00a, StandardSpecification for Nitrile Examination Gloves. They are madefrom nitrile rubber compound. They are blue in color and arepowder free. |
| Intended Use of the Device | Medtexx™Blue Colour Powder Free Nitrile RubberExamination Gloves are 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 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 rinsingprocesses. |
| Brief Description of Non-clinical Tests | Testing performed per ASTM D 6319-00a. StandardSpecification for Nitrile Examination Gloves and 21 CFR800.20. Gloves meet all the current ASTM D 6319-00aStandard Specification for Nitrile Examination Gloves.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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are drawn with thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2002
Latexx Manufacturing Sdn. Bhd. C/O Mr. Law Siau Woei Medtexx Partners, Incorproated 216 Charles Street Hackensack, New Jersey 07601
Re: K022548
Trade/Device Name: Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: July 15, 2002 Received: August 1, 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 vour 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 (OS) 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 Runge.
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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Attachment 2
Medtexx™ Blue Colour Powder Free Nitrile Rubber Examination Gloves
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Image /page/4/Picture/2 description: The image shows the logo for "LATEXX MANUFACTURING SDN BHD (165989-U)". The word "LATEXX" is in large, bold, black letters. Below the word is a line, and below the line is the company name and registration number.
INDICATIONS FOR USE
Applicant
LATEXX MANUFACTURING SDN.BHD. PT 5054, Kamunting Industrial Estate P.O. Box 9 34600 Taiping Perak MALAYSIA
510(k) Number (if known)
Device Name
MEDTEXX™ BLUE COLOUR POWDER FREE NITRILE RUBBER EXAMINATION GLOVE
Indications For Use :
Blue Colour Powder Free Nitrile Rubber Examination Gloves 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)
Chun S. Lim
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use Per 21 CFR 801.109
ﺗﺮ
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.