(111 days)
Powder Free Synthetic Rubber Latex (BarrierPro™) 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.
CleantexxTM Powder Free Synthetic Rubber Latex 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 BarrierProTM synthetic rubber latex, a polybutadiene based copolymer. They are natural white in color and are powder free.
Here's a breakdown of the acceptance criteria and study information for the Cleantexx™ Powder Free Synthetic Rubber Latex Examination Gloves, based on the provided 510(k) summary:
This device is not an AI/ML powered medical device, therefore, many of the requested fields are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| Physical Properties: | |
| ASTM D 6319-00a | Meets all current ASTM D 6319-00a specifications |
| Biocompatibility: | |
| Primary skin irritation (USP <88>) | No irritation |
| Delayed contact sensitization (ISO 10993) | No sensitization |
| Powder-Free Status: | |
| Presence of starch (USP iodine test) | Negative for starch |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided summary. The summary indicates "Testing performed per ASTM D 6319 - 00a" and "Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig." The specific number of gloves/animals tested for each of these would be detailed in the full test reports, which are not included here.
- Data Provenance: The manufacturing company is LATEXX MANUFACTURING SDN. BHD. based in Malaysia. The testing would have been conducted by them or a contracted laboratory. The summary does not specify the country of origin of the data beyond the manufacturer's location. The studies are non-clinical (laboratory and animal-based) rather than human observational (retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the device is an examination device (gloves) and not an AI/ML or diagnostic device that requires expert ground truth for interpretation of results. The "ground truth" here is defined by meeting specified engineering and biological safety standards (e.g., ASTM standards, USP tests), which are evaluated through objective laboratory measurements and animal studies, not expert consensus on interpretations.
4. Adjudication Method for the Test Set
Not applicable. As this is not an AI/ML or diagnostic device, there is no need for adjudication of results by experts. The tests performed are objective measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. No algorithm or AI component is involved in this device.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation is based on:
- Standard Specifications: Meeting the performance requirements outlined in ASTM D 6319-00a, which defines physical properties for examination gloves.
- Biocompatibility Standards: Absence of primary skin irritation and delayed contact sensitization, assessed through established animal testing protocols (e.g., USP <88> for irritation, ISO 10993 for sensitization guidance).
- Chemical Purity Standards: Negative result for the presence of starch via the USP iodine test, demonstrating the "powder-free" claim.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore, no training set for an algorithm was used.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As no training set was used, no ground truth needed to be established for it.
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510(k) SUMMARY
JAN 2 3 2002
CLEANTEXX™ POWDER FREE SYNTHETIC RUBBER LATEX 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 1111 |
| Submitter 's Fax Number | 605 891 1088 |
| Name of Contact Person | Teoh, Choh Shee |
| Date of Preparation | August 20, 2001 |
| Name of Device | |
| Trade Name | : CleantexxTM Powder Free Synthetic Rubber Latex(BarrierProTM) Examination Glove |
| Common Name | : Synthetic Rubber Examination Gloves |
| Classification Name | : Patient Examination Gloves, Powder-free |
| Legally Marketed Device to Which Equivalencyis Being Claimed | CleantexxTM Powder Free Synthetic Rubber LatexExamination 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 | CleantexxTM Powder Free Synthetic Rubber LatexExamination Glove meets all the current specificationslisted under the ASTM Specification D 6319-00, StandardSpecification for Nitrile Examination Gloves for MedicalApplication. They are made from BarrierProTM syntheticrubber latex, a polybutadiene based copolymer. They arenatural white in color and are powder free. |
| Intended Use of the Device | Cleantexx™ Powder Free Synthetic Rubber LatexExamination 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 BarrierPro™ (Trade Mark of ReichholdChemicals, Inc. of USA) synthetic rubber latex compoundand the initial products are low powdered synthetic rubberlatex gloves. These gloves are then further processed intopowder free gloves using the existing technology, i.e.multiple washing and 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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K01 3303
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2002
Mr. Teoh Choh Shee General Manager Latexx Manufacturing Sdn. Bhd. PT. 5054, Kamunting Industrial Estate Taiping, Perak, MALAYSIA
Re: K013303
R015505
Trade/Device Name: Cleantexx Powder-Free Synthetic Latex Examination Glove made with "Barrier-Pro" Butadiene Co-Polmer Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 11, 2001 Received: December 11, 2001
Dear Mr.Shee:
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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinente, or to activend Cosmetic Act (Act) that do not require approval of a premarket the redelar I ood, Drag, and Commay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include econders 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 (1 NE ), It ind of our 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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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 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Cleantexx™ Powder-free Synthetic Rubber Latex (BarrierPro™) Examination Glov
Image /page/4/Picture/1 description: The image shows a logo for Latex Manufacturing SDN BHD. The logo includes the word "LATEX" in large, bold letters. Below the word "LATEX" is the word "MANUFACTURING" and the text "(Formerly known as MRG Industries Sdn. Bhd.)".
Attachment 2
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)
KO13303
Device Name
Cleantexx Powder-Free Synthetic Latex Examination Glove Cleantexx Powder-Pro™" Butadiene Co-polymer
Indications For Use ・・
:
Powder Free Synthetic Rubber Latex (BarrierPro™) 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.
Concurrence of CDRH Office of Device Evaluation (ODE)
Qliss S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
§ 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.