(91 days)
Mint Flavour, Blue Colour Powder Free BarrierPro™ Copolymer 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.
Cleantexx TM Mint Flavour, Blue Colour Powder Free BarrierPro TM Polybutadiene Copolymer Examination Glovesmeets all the current specifications listed under the ASTMSpecification D 6319-00a, Standard Specification for NitrileExamination Gloves for Medical Application. They aremade from BarrierPro TM synthetic copolymer rubber latex, apolybutadiene based copolymer. They are mint flavour,blue in colour, are powder free.
The provided text describes the regulatory clearance of "CLEANTEXX™ MINT FLAVOUR, BLUE COLOUR POWDER FREE BARRIER PRO™ POLYBUTADIENE COPOLYMER EXAMINATION GLOVES". This is a medical device, specifically an examination glove, and the submission is for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new medical diagnosis or treatment through extensive clinical studies like those for AI/ML-based diagnostic devices.
Therefore, many of the requested points are not applicable to this type of device and submission. I will address the relevant points and indicate when information is not provided or applicable.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from ASTM D 6319-00a) | Reported Device Performance |
|---|---|---|
| Physical Properties | All current specifications listed under ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. | "Gloves meet all the current ASTM D 6319-00a Standard Specification for Nitrile Examination Gloves." |
| Biocompatibility | Not explicitly stated, but generally implies no irritation or sensitization. | Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig indicate no irritation or sensitization. |
| Powder Content | Negative for starch (for powder-free claims). | Final product is negative for the presence of starch using the USP iodine test. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a series of non-clinical tests performed according to recognized standards and methods.
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 submission does not specify the exact sample sizes used for each test (e.g., for physical properties, irritation, or sensitization). ASTM standards typically prescribe minimum sample sizes for specific tests.
- Data Provenance: The tests were performed by the manufacturer, LATEXX MANUFACTURING SDN. BHD., located in Malaysia. The tests are non-clinical (laboratory/animal-based) as opposed to human subject data.
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)
Not applicable. For this type of device (examination gloves), ground truth is established through objective, standardized physical, chemical, and biological tests, not through expert human interpretation or consensus like in diagnostic imaging. Biocompatibility testing (irritation/sensitization) involves animal models and laboratory analysis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically employed in studies where human expert disagreement on interpretation of data is possible and needs resolution (e.g., in medical image reading). The nature of the tests for examination gloves (physical, chemical, animal-based) does not require such 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
Not applicable. This is not an AI/ML diagnostic device, and therefore, MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on objective measurements and observations derived from:
- Standardized test methods (e.g., breaking strength, elongation, dimensions) as specified in ASTM D 6319-00a.
- Laboratory analysis (e.g., USP iodine test for starch).
- Animal test results for biocompatibility (primary skin irritation in rabbits, delayed contact sensitization in guinea pigs).
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device requiring a training set.
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OCT 1 8 2002
510(k) SUMMARY
1022346
CLEANTEXX™ MINT FLAVOUR, BLUE COLOUR POWDER FREE BARRIER PRO™ POLYBUTADIENE COPOLYMER 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 | June 28, 2002 |
| Name of Device | |
| Trade Name | Cleantexx TM Mint Flavour, Blue Colour Powder Free BarrierPro TM Polybutadiene Copolymer Examination Gloves |
| Common Name | Synthetic 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 | Cleantexx TM Mint Flavour, Blue Colour Powder Free BarrierPro TM Polybutadiene Copolymer Examination Gloves asdescribed 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 for Medical Application. |
| Description of the Device | Cleantexx TM Mint Flavour, Blue Colour Powder Free BarrierPro TM Polybutadiene Copolymer Examination Glovesmeets all the current specifications listed under the ASTMSpecification D 6319-00a, Standard Specification for NitrileExamination Gloves for Medical Application. They aremade from BarrierPro TM synthetic copolymer rubber latex, apolybutadiene based copolymer. They are mint flavour,blue in colour, are powder free. |
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| Intended Use of the Device | Cleantexx™ Mint Flavour, Blue Colour Powder Free BarrierPro™ Polybutadiene Copolymer Examination Gloves isintended for single use for medical purposes that is wornon the hand of health care and similar personnel to preventcontamination between the health care personnel and thepatients. |
|---|---|
| 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 butadiene copolymercompound and the initial products are low powderedsynthetic copolymer gloves. These gloves are then furtherprocessed into powder free gloves using the existingtechnology, i.e. multiple washing ad rinsing processes. |
| 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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OCT 1 8 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Teoh Choh Shee General Manager Latexx Manufacturing Sdn Bhd PT 5054, Jalan Perusahaan Tiga, Kamunting Industrial Estate, P. O. Box 9, 34600 Kamuting, Taiping, Perak, MALAYSIA
Re: K022346
Trade/Device Name: Cleantexx™ Mint Flavour, Blue Colour Powder Free BarrierPro™ Polybutadience Copolymer Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 26, 2002 Received: October 1, 2002
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 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. Shee
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 A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Cleantexx 7M Mint Flavour, Blue C Powder-free Barrier Pro TM Polybutadien Copolymer Examination Gloves
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 with a horizontal line underneath. To the right of the word is a black circle with white lines inside, resembling a hand.
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)
K022346 *
Device Name
MINT FLAVOUR, BLUE COLOUR POWDER FREE BARRIERPROA COPOLYMER RUBBER EXAMINATION GLOVE
Indications For Use
. .
Mint Flavour, Blue Colour Powder Free BarrierPro™ Copolymer 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.
Concurrence of CDRH Office of Device Evaluation (ODE)
Chin S. Lim
Division of Anesthesinhay General Hospital Infection Control. Denta
510(k) Number. K022342
Prescribtion Use
§ 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.