(99 days)
Blue Colour, Chlorinated Powder Free Nitrile 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.
The Blue Colour, Chlorinated Powder Free Nitrile Examination Gloves is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LZA ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D 6319 - 00a Standard Specification for Nitrile Examination Gloves for Medical Application1. They are made from nitrile compound(dispersion of butadiene acrylonitrile copolymer. They are blue in color and are powder free.
The provided FDA 510(k) summary is for a medical device that is not an AI/ML powered device. The device is "BLUE COLOUR, CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES." Therefore, the requested information regarding AI/ML device performance, such as acceptance criteria for AI models, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, training set details, and ground truth establishment, is not applicable to this submission.
The summary describes the device's adherence to established standards for examination gloves.
Here's a breakdown of the relevant information provided for this non-AI device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (ASTM D 6319 - 00a Standard Specification for Nitrile Examination Gloves for Medical Application and 21 CFR 800.20) | Reported Device Performance |
|---|---|
| All current specifications listed under ASTM D 6319 - 00a | Gloves meet all current ASTM D 6319-00a specifications. Including: |
| Absence of irritation (Primary skin irritation testing in the rabbit) | No irritation |
| Absence of sensitization (Delayed dermal contact sensitization study in the guinea pigs) | No sensitization |
| Performance and biocompatibility requirements | Meets all performance and biocompatibility requirements |
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 Non-Clinical Tests: Not explicitly stated in terms of an exact number of gloves. The studies refer to "testing performed per ASTM D 6319 - 00a," and "Primary skin irritation testing in the rabbit and delayed dermal contact sensitization study in the guinea pigs." ASTM standards typically specify sampling plans, but the specific numbers for this submission are not detailed.
- Data Provenance: The manufacturing company, MEDTEXX MANUFACTURING SDN. BHD., is located in Malaysia. The testing would presumably be conducted by or for this manufacturer. The nature of these tests (material properties, biological safety) makes the "origin of data" less about observational patient data and more about laboratory and animal testing. These are inherently prospective tests on the product itself.
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 question is not applicable as the device is not an AI/ML system that requires expert interpretation to establish a ground truth. The "ground truth" for these gloves is their physical properties and biological safety as measured by established laboratory and animal testing protocols, which are objective and do not rely on human expert consensus interpretation of complex data like medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable for the same reasons as #3. Adjudication methods are relevant for subjective interpretations or complex diagnostic tasks where multiple human readers might disagree. The tests performed for examination gloves are standardized physical and biological assays.
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 question is not applicable as the device is not an AI/ML system and does not involve human readers interpreting data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device 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's performance is based on objective measurements and observations from standardized physical, chemical, and biological tests following ASTM D 6319 - 00a and 21 CFR 800.20. This includes:
- Physical properties (e.g., tensile strength, elongation, dimensions, freedom from holes)
- Chemical properties (e.g., powder residue if applicable, though these are powder-free)
- Biocompatibility (primary skin irritation in rabbits, delayed dermal contact sensitization in guinea pigs).
8. The sample size for the training set
- This question is not applicable as the device is not an AI/ML system and does not have a "training set."
9. How the ground truth for the training set was established
- This question is not applicable as the device is not an AI/ML system and does not have a "training set."
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: $710(k) SUMMARY
BLUE COLOUR, CHLORINATED POWDER FREE NITRILE EXAMINATION G
| OCT 4 2007 | |
|---|---|
| Submitter's Name | MEDTEXX MANUFACTURING SDN. BHD. |
| Submitter's Address | PT 4004, Kamunting Industrial Estate |
| 34600 Taiping, Perak, | |
| Malaysia | |
| Submitter's Phone Number | 605-891 1111 / 605-891 5555 |
| Submitter's Fax Number | 605-891 1088 |
| Name of Contact Person | Ooi Loon Seng |
| Date of Preparation | |
| Name of Device | |
| Trade Name | : BLUE COLOUR, CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVES |
| Common Name | : Nitrile Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Legally Marketed Device to which Equivalency isBeing Claimed | Blue Colour, Chlorinated Powder Free NitrileExamination Gloves as described in this 510 KNotification is substantially equivalent to thecurrent Class 1 Patient Examination glovebearing the product code 80LZA ( 21 CFR880.6250 ). It meets all the current specificationslisted under the ASTM Specification D 6319 -00a Standard Specification for NitrileExamination Gloves for Medical Application. |
| Description of the Device | The Blue Colour, Chlorinated Powder Free NitrileExamination Gloves is substantially equivalent tothe Class 1 patient examination glove bearing theproduct code 80LZA ( 21 CFR 880.6250 ). It |
| meets all the current specifications listed underthe ASTM Specification D 6319 - 00a StandardSpecification for Nitrile Examination Gloves forMedical Application1. They are made from nitrilecompound(dispersion of butadiene acrylonitrilecopolymer. They are blue in color and arepowder free. | |
| Intended Use of the Device | The Blue Colour, Chlorinated Powder Free NitrileExamination Gloves are intended for single usefor medical purposes that is worn on the hand ofhealth care and similar personnel to preventcontamination between the health care personneland the patients. |
| Summary of Technological CharacteristicCompared to the Predicate Device | There is no different technological characteristic.Gloves are made from nitrile compound(dispersion of butadiene acrylonitrile copolymer)and the initial products are powder free nitrileexamination gloves. |
| Brief Description of Non-Clinical Tests | Testing performed per ASTM D 6319 - 00aStandard Specification for Nitrile ExaminationGloves for Medical Application and 21 CFR800.20. Gloves meet all the current ASTM D6319-00a.Primary skin irritation testing in the rabbit anddelayed dermal contact sensitization study in theguinea pigs indicate no irritation or sensitization. |
| Brief description of Clinical Tests | No new clinical tests were conducted under this510(k). |
| Conclusions Drawn from the Non-Clinical andClinical Tests | Non-Clinical laboratory and animal based testdata indicate that the powder free product meetsall performance and biocompatibilityrequirements. |
| 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 and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mdm. Ooi Loon Seng Regulatory Affairs Manager Medtexx Manufaxturing Sdn. Bhd. PT 4004 Kamunting Industrial Estate 34600 Taiping, Perak MALAYSIA
OCT 4 2007
Re: K071740
Trade/Device Name: Blue Colour, Chlorinated Powder Free Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 19, 2007 Received: September 24, 2007
Dear Mdm. Seng:
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 - Mdm. Seng
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 yours,
Chih-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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INDICATIONS FOR USE
Applicant
MEDTEXX MANUFACTURING SDN. BHD. PT 4004, Kamunting Industrial Estate, 34600 Taiping, Perak, Malaysia.
510(k) Number (if known)
071740 *
Device Name
BLUE COLOUR, CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES
Indications For Use
Blue Colour, Chlorinated Powder Free Nitrile 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 )
Prescription Use OR Over-The-Counter X
Per 21 CFR 801.109
(Division Sign-Off)
Division of Anesthesiology, General Hospital GCJ for ssm
Infection Control, Dental Devices 10/04/07
510(k) Number: K071740
§ 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.