(91 days)
Not Found
Not Found
No
The device is a medical examination glove and the description focuses on material properties and performance testing according to ASTM standards. There is no mention of AI or ML.
No
The device is described as an examination glove intended to prevent contamination between healthcare personnel and the patient, not to treat or cure a disease or condition.
No
The device is described as an examination glove intended to prevent contamination, not to diagnose a condition.
No
The device is a physical examination glove made of copolymer rubber, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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." This describes a barrier device for personal protection and infection control, not a device used to examine specimens taken from the human body.
- Device Description: The description focuses on the material, color, and features of the glove, and its compliance with a standard for examination gloves. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting substances, diagnosing conditions, or any other activities typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical device, specifically an examination glove, but not an IVD.
N/A
Intended Use / Indications for Use
Cleantexx™ Mint Flavour, Blue Colour Powder Free Barrier Pro™ Polybutadiene Copolymer Examination Gloves 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
80LZA, LZA
Device Description
Cleantexx ™ Mint Flavour, Blue Colour Powder Free Barrier Pro ™ Polybutadiene Copolymer Examination Gloves meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from BarrierPro ™ synthetic copolymer rubber latex, a polybutadiene based copolymer. They are mint flavour, blue in colour, 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
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)
Non-clinical Tests: Testing performed per ASTM D 6319 - 00a, Standard Specification for Nitrile Examination Gloves and 21 CFR 800.20. Gloves meet all the current ASTM D 6319-00a Standard Specification for Nitrile Examination Gloves. 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.
Clinical Tests: No new clinical tests were conducted under this 510(k).
Conclusions: Non-clinical laboratory and animal based test data indicate that the powder-free product meets all performance and biocompatibility requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 Barrier |
| Pro 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 Equivalency | |
| is Being Claimed | Cleantexx TM Mint Flavour, Blue Colour Powder Free Barrier |
| Pro TM Polybutadiene Copolymer Examination Gloves 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 | Cleantexx TM Mint Flavour, Blue Colour Powder Free Barrier |
| Pro TM Polybutadiene Copolymer Examination Gloves | |
| meets all the current specifications listed under the ASTM | |
| Specification D 6319-00a, Standard Specification for Nitrile | |
| Examination Gloves for Medical Application. They are | |
| made from BarrierPro TM synthetic copolymer rubber latex, a | |
| polybutadiene based copolymer. They are mint flavour, | |
| blue in colour, are powder free. |
1
| Intended Use of the Device | Cleantexx™ Mint Flavour, Blue Colour Powder Free Barrier
Pro™ Polybutadiene Copolymer Examination Gloves 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 butadiene copolymer
compound and the initial products are low powdered
synthetic copolymer gloves. These gloves are then further
processed into powder free gloves using the existing
technology, i.e. multiple washing ad rinsing processes. |
| Brief Description of Non-clinical Tests | Testing performed per ASTM D 6319 - 00a, Standard
Specification for Nitrile Examination Gloves and 21 CFR
800.20. Gloves meet all the current ASTM D 6319-00a
Standard Specification for Nitrile Examination Gloves.
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. |
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
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.
3
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