(76 days)
Black Colour Powder Free Nitrile Rubber Examination Glove 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.
Black Colour Powder Free Nitrile Rubber Examination Glove as described in this 510k Notification is substantially equivalent to the current Class I patient examination glove bearing the product code 80LZA (21CFR 880.6250). It meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves. They are made from nitrile rubber compound. They are black in colour and are powder free.
This document describes the acceptance criteria and the study that proves the device meets those criteria for the Black Colour Powder-Free Nitrile Rubber Examination Glove (K034052).
The device is a patient examination glove and is subjected to performance and biocompatibility testing against relevant standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Black Colour Powder-Free Nitrile Rubber Examination Glove are based on ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves. The device's performance is reported to meet all these current specifications.
| Acceptance Criterion (from ASTM D 6319-00a) | Reported Device Performance |
|---|---|
| Physical Properties | Meets all specifications |
| (Specific physical properties like tensile strength, elongation, force at break are implied by meeting the standard, though not detailed in the summary.) | |
| Acceptable Quality Limit (AQL) for Defects | |
| (Specific AQLs for critical, major, and minor defects are implied by meeting the standard, though not detailed in the summary.) | Meets all specifications |
| Biocompatibility | |
| Primary skin irritation | No irritation |
| Delayed contact sensitization | No sensitization |
| Powder Content (for powder-free) | Negative for starch (using USP iodine test) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes used for each test. However, it mentions "Testing performed per ASTM D 6319 - 00a" and "21 CFR 800.20", indicating that typical sample sizes and methodologies prescribed by these standards would have been followed.
The data provenance is from non-clinical tests conducted by the manufacturer, Latexx Manufacturing Sdn. Bhd., located in Malaysia. The testing described is retrospective in the sense that it was performed on finished product samples to demonstrate compliance with standards for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the "ground truth" for this device is established by objective, standardized physical, chemical, and biological tests, not by expert interpretation of data like in medical imaging. The expertise lies in conducting the tests according to the specified ASTM and FDA guidelines and interpreting the quantitative results.
4. Adjudication Method for the Test Set
This is not applicable to this type of device and testing. The evaluation is based on objective measurements and compliance with numerical and qualitative thresholds defined by the standards (ASTM D 6319-00a and 21 CFR 800.20 for biocompatibility). There is no "adjudication" in the sense of reconciling differing expert opinions.
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
No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve human interpretation of complex data, often aided by AI. Patient examination gloves are a Class I medical device and do not involve AI or human interpretation in their intended use.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study as described is not applicable. This device is a physical product (examination glove), not an algorithm or software. Its performance is evaluated through physical, chemical, and biological testing, not through algorithmic output.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Established standards and specifications: Primarily ASTM D 6319-00a for physical properties and defect levels.
- Objective laboratory test results: For biocompatibility (primary skin irritation and sensitization) and powder content (USP iodine test).
- Regulatory compliance: Specifically, 21 CFR 800.20 for biological evaluation.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not an AI or machine learning model, so there is no "training set" in the context of data-driven systems. The term "training set" is usually reserved for machine learning algorithm development.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, this question is not applicable.
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MAR 1 5 2004
Attachment 16
Black Colour Powdered Nitrile Rubber Examination Gloves
510(k) SUMMARY
PRE-POWDERED GREEN COLOUR NITRILE RUBBER EXAMINATION GLOVES
| Submitter's Name | LATEXX MANUFACTURING SDN. BHD. |
|---|---|
| Submitter's Address | PT 5054, Kamunting Industrial Estate |
| P.O. Box 9, 34600 Taiping, Perak | |
| Malaysia | |
| Submitter's Phone Number | 605 891 5555 |
| Submitter 's Fax Number | 605 891 1088 |
| Name of Contact Person | Lim Chian Chian |
| Date of Preparation | December 15, 2003 |
| Name of Device | |
| Trade Name | : Black Colour Powder Free Nitrile Rubber ExaminationGlove |
| Common Name | : Nitrile Rubber Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Legally Marketed Device to Which Equivalencyis Being Claimed | Black Colour Powder FreeNitrile Rubber ExaminationGlove as described in this 510k Notification is substantiallyequivalent to the current Class I patient examination glovebearing the product code 80LZA (21CFR 880.6250).meets all the current specifications listed under the ASTMSpecification D 6319-00a, Standard Specification for NitrileExamination Gloves. |
| Description of the Device | Black Colour Powder Free Nitrile Rubber ExaminationGlove as described in this 510k Notification is substantiallyequivalent to the current Class I patient examination glovebearing the product code 80LZA (21CFR 880.6250). Itmeets all the current specifications listed under the ASTMSpecification D 6319-00a, Standard Specification for NitrileExamination Gloves. They are made from nitrile rubbercompound. They are black in colour and are powder free. |
| Intended Use of the Device | Black Colour Powder Free Nitrile Rubber ExaminationGlove is intended for single use for medical purposes thatis worn on the hand of health care and similar personnel toprevent contamination between the health care personneland 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 glovesare then further processed into powder free gloves usingthe existing 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 for MedicalApplication and 21 CFR 800.20. Gloves meet all thecurrent ASTM D 6319-00a Standard Specification forNitrile 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 pre-powdered product meets all performance andbiocompatibility requirements. |
| Other Information Deemed Necessary by FDA | Not applicable. |
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Attachment 16
Image /page/1/Picture/2 description: The image contains a sequence of alphanumeric characters that appear to be handwritten. The characters are 'K034252'. The characters are written in a simple, somewhat stylized manner, with varying stroke thicknesses. The image has a white background.
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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2004
Latexx Manufacturing SDN.BHD C/O Mr. Law Siau Woei (Terry Law) Medtexx Partners, Incorporated 216 Charles Street Hackensack, New Jersey 07601
Re: K034052
Trade/Device Name: Black Colour Powder-Free Nitrile Rubber Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 15, 2003 Received: January 26, 2004
Dear Mr. Terry Law:
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.
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Page 2 -Mr. Law
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. 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Ching-Lin, Ph.D.
Chiu Lin, Ph.D. 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
Black Colour Powder-free Nitrile Rubber Examination Glove
Image /page/4/Picture/2 description: The image shows the logo for LATEXX MANUFACTURING SDN BHD (165989-U). The logo is black and white and features the word "LATEXX" in large, bold letters. To the right of the word is a graphic of three hands. The text "MANUFACTURING SDN BHD (165989-U)" is printed in smaller letters below the logo.
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
BLACK COLOUR POWDER FREE NITRILE RUBBER EXAMINATION GLOVE.
Indications For Use
Black Colour Powder Free Nitrile Rubber Examination Glove 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE II NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Martha O'Lone
Interim Branch Chief
Martha O'Lone
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510(k) Number
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§ 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.