(99 days)
80LZA
80LZA (21 CFR 880.6250)
No
The device is a medical glove and the description focuses on material properties and performance standards, with no mention of AI or ML.
No
The device, a nitrile examination glove, is intended for contamination prevention and does not provide therapy.
No
The device is a glove, which is used for protection and contamination prevention, not for diagnosing medical conditions.
No
The device is a physical examination glove made of nitrile, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient." This describes a barrier device used for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the material, color, and physical properties of the glove, and its equivalence to a Class 1 patient examination glove. This aligns with a protective barrier device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device is a physical barrier.
N/A
Intended Use / 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."
Product codes
LZA
Device Description
"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."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"health care and similar personnel"
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
"Testing performed per ASTM D 6319 - 00a Standard Specification for Nitrile Examination Gloves for Medical Application and 21 CFR 800.20. Gloves meet all the current ASTM D 6319-00a. Primary skin irritation testing in the rabbit and delayed dermal contact sensitization study in the guinea pigs indicate no irritation or sensitization."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
current Class 1 Patient Examination glove bearing the product code 80LZA ( 21 CFR 880.6250 )
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 POWDER |
| FREE NITRILE EXAMINATION GLOVES | |
| Common Name | : Nitrile Examination Gloves |
| Classification Name | : Patient Examination Gloves |
| Legally Marketed Device to which Equivalency is | |
| Being Claimed | Blue Colour, Chlorinated Powder Free Nitrile |
| Examination Gloves as described in this 510 K | |
| Notification is substantially equivalent to the | |
| current 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 Application. | |
| Description of the Device | 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. | |
| Intended Use of the Device | The Blue Colour, Chlorinated Powder Free Nitrile |
| Examination Gloves are intended for single use | |
| for medical purposes that is worn on the hand of | |
| health care and similar personnel to prevent | |
| contamination between the health care personnel | |
| and the patients. | |
| Summary of Technological Characteristic | |
| Compared 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 nitrile | |
| examination gloves. | |
| Brief Description of Non-Clinical Tests | Testing performed per ASTM D 6319 - 00a |
| Standard Specification for Nitrile Examination | |
| Gloves for Medical Application and 21 CFR | |
| 800.20. Gloves meet all the current ASTM D | |
| 6319-00a. | |
| Primary skin irritation testing in the rabbit and | |
| delayed dermal contact sensitization study in the | |
| guinea pigs indicate no irritation or sensitization. | |
| Brief description of Clinical Tests | No new clinical tests were conducted under this |
| 510(k). | |
| Conclusions Drawn from the Non-Clinical and | |
| Clinical Tests | Non-Clinical laboratory and animal based test |
| data indicate that the powder free product meets | |
| all performance and biocompatibility | |
| requirements. | |
| 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