(111 days)
80LZA
Not Found
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 'Intended Use' section states that the device is an "Examination Glove ... to prevent contamination between the healthcare personnel and the patient," which indicates a barrier function, not a therapeutic one.
No
Explanation: The device is described as an examination glove intended to prevent contamination. There is no mention of it being used to detect, monitor, or diagnose a medical condition.
No
The device is a physical examination glove made of synthetic rubber latex, 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 glove 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 derived from the human body for the purpose of providing information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury.
- Device Description: The description focuses on the material, color, and powder-free nature of the glove, and its compliance with a standard for examination gloves. This aligns with a barrier device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device is a medical device, specifically an examination glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cleantexx™ Powder Free Synthetic Rubber Latex Examination Glove is 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.
Product codes
LZA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare 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
Non-clinical laboratory and animal based test data indicate that the powder-free product meets all performance and biocompatibility requirements.
Key Metrics
Not Found
Predicate Device(s)
CleantexxTM Powder Free Synthetic Rubber Latex 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 for Medical Application.
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.
0
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 Equivalency | |
| is Being Claimed | CleantexxTM Powder Free Synthetic Rubber Latex |
| 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 for Medical | |
| Application. | |
| Description of the Device | 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. | |
| Intended Use of the Device | Cleantexx™ Powder Free Synthetic Rubber Latex |
| Examination Glove is 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 Characteristics | |
| Compared to the Predicate Device | There is no different technological characteristic. Gloves |
| are made from BarrierPro™ (Trade Mark of Reichhold | |
| Chemicals, Inc. of USA) synthetic rubber latex compound | |
| and the initial products are low powdered synthetic rubber | |
| latex gloves. These gloves are then further processed into | |
| powder 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, 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 | |
| contact sensitization testing in the guinea pig indicate no | |
| irritation or sensitization. | |
| Final product is negative for the presence of starch using | |
| the USP iodine test. | |
| 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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K01 3303
·
2
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.
3
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
4
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