(111 days)
Not Found
Not Found
No
The device is a surgical glove and the description focuses on material properties and testing standards, with no mention of AI or ML.
No
A surgeon's glove is not considered a therapeutic device as its primary function is protection, not treatment or therapy.
No
Explanation: The device is described as a "Surgeon's glove" which is used for protection from contamination, not for diagnosing conditions.
No
The device is a surgical glove, which is a physical hardware product made of natural rubber, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn by operating room personnel to protect a surgical wound from contamination. This is a barrier device used during a medical procedure, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description focuses on the physical properties and standards met by the glove (ASTM D3577-01a2).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This surgical glove does not fit that description.
N/A
Intended Use / Indications for Use
MAXITEX NEURO PF surgical gloves are disposable and sterile devices intended to be worn by healthcare personnel to prevent cross contamination between the user and the patient during procedures.
This Surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
Device Description
MAXITEX NEURO PF, powderfree surgical glove meets the requirements for surgical gloves described by the American Standard for Testing and Material ASTM D3577-01a2.
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
healthcare personnel, operating room 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)
Test conducted per ASTM D3577-01ae2, ASTM D 412, ASTM D5712 indicates that the product meet the requirements.
Primary Skin Irritation test ASTM F 719-81 and Dermal Sensitization Test ASTM F 720-81 (2002) indicates no sensitization or irritation.
It can be concluded that MAXITEX NEURO PF surgical glove will perform according to the performance standards referenced and therefore meets ASTM standards., FDA requirements and labeling claims.
This device is substantially equivalent to the currently marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nutex Micro-Thin Surgical Gloves
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).
0
TERANG NUSA Sdn Bhd
510(k) Summary MAXITEX Neuro PF
K04/437
510(k) Summary
SEP 16 2004
| Submitter Name | Terang Nusa Sdn Bhd |
|---|---|
| Submitter Address | 1, Jalan 8 |
| Pengkalan Chepa 2 Industrial Zone | |
| 16100 Kota Bharu, | |
| Kelantan , Malaysia | |
| Submitter Telephone | +60 9 7717171 |
| Submitter Fax | +60 9 7747757 |
| Contact Person | LOW , Chin Guan |
| Date of preparation | 11 May 2004 |
| Trade Name | MAXITEX NEURO PF |
| Common Name | Sterile surgical glove, Powderfree. Contain less |
| than 50 microgram / gram of water extractable | |
| protein. | |
| Classification | Surgeon's Glove |
| Legally marketed device to which | |
| substantial equivalence is being | |
| claimed. | The MAXITEX NEURO PF, described in this |
| 510(k) is substantially equivalent to the Nutex | |
| Micro-Thin Surgical Gloves that is currently | |
| marketed. | |
| Description of device | MAXITEX NEURO PF, powderfree surgical |
| glove meets the requirements for surgical gloves | |
| described by the American Standard for Testing | |
| and Material ASTM D3577-01a2. | |
| Intended Use of the device | MAXITEX NEURO PF surgical gloves are |
| disposable and sterile devices intended to be worn | |
| by | |
| healthcare personnel to prevent cross | |
| contamination between the user and the patient | |
| during procedures. |
1
Image /page/1/Picture/0 description: The image shows a logo with a compass-like design on the left. To the right of the logo, the text "TERANG NUSA Sdn Bhd" is displayed in bold. Below this text, the phrase "510(k) Summary MAXITEX NEURO PF" is written, indicating a summary related to a product named MAXITEX NEURO PF.
510 K Summary ( continued)
| Brief description of non-clinical
tests | Test conducted per ASTM D3577-01ae2, ASTM
D 412, ASTM D5712 indicates that the product
meet the requirements.
Primary Skin Irritation test ASTM F 719-81 and
Dermal Sensitization Test ASTM F 720-81 (2002)
indicates no sensitization or irritation. |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Brief description of clinical tests | Not required |
| Conclusion drawn from clinical and
non clinical tests | It can be concluded that MAXITEX NEURO PF
surgical glove will perform according to the
performance standards referenced and therefore
meets ASTM standards., FDA requirements and
labeling claims.
This device is substantially equivalent to the
currently marketed devices. |
| Additional information deemed
necessary by the FDA | None |
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of the human spirit.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2004
Mr. Chin-Guan Low Managing Director Terang Nusa Sdn Bhd 1, Jalan 8, Pengkalan Chepa 2 Industrial Zone 16100 Kota Bharu, Kelantan MALAYSIA
Re: K041437
Trade/Device Name: MAXTEX NEURO PF Latex Powderfree Surgeon's Glove, Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 26, 2004 Received: September 2, 2004
Dear Mr. Low:
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. Low
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) I mo reter 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), nlease 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,
Cluts
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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Image /page/4/Picture/0 description: The image shows a compass rose with the letter 'H' superimposed on each of the four cardinal directions. The compass rose is a star-shaped figure with four points, each pointing in a different direction. The letter 'H' is stylized and appears to be integrated into the design of the compass rose. The image is in black and white.
TERANG NUSA Sdn Bhd
S10(k) Submission for MAXITEX NEURO PF
Indication for use Statement 3.
: ・
:
K041437 : 510(k) Number
Device Name
MAXTEX NEURO PF Latex Powderfree Surgeon's Glove, polymer coated and contains 50 micrograms or less of total water extractable protein per gram.
Indication for use
This Surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Prescription Use (Part 21 CFR 801 Subpart D) AND/ ()R
Over the counter (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR Office of Device Evaluation (ODE)
Kein Muluy
Sign-Off)
of Anesthesiology, General Hospital, Division Control, Dental D
510(k) Number:_