← Product Code [KGO](/productcode/KGO) · K041437 # MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE (K041437) _Terang Nusa Sdn Bhd · KGO · Sep 16, 2004 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K041437 ## Device Facts - **Applicant:** Terang Nusa Sdn Bhd - **Product Code:** [KGO](/productcode/KGO.md) - **Decision Date:** Sep 16, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4460 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery ## 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. ## Device Story MAXITEX NEURO PF is a sterile, powder-free, natural rubber surgical glove. It is worn by operating room personnel to provide a barrier against cross-contamination between the user and the patient, specifically protecting surgical wounds. The device is a disposable, single-use product. It is intended for use in clinical settings, specifically the operating room. ## Clinical Evidence No clinical data. Bench testing only. Testing conducted per ASTM D3577-01ae2 (physical properties), ASTM D412 (tensile properties), ASTM D5712 (protein content), ASTM F719-81 (primary skin irritation), and ASTM F720-81 (dermal sensitization). Results indicate the device meets all requirements with no irritation or sensitization observed. ## Technological Characteristics Natural rubber surgical glove; powder-free; polymer coated. Protein content < 50 micrograms/gram. Complies with ASTM D3577-01a2, ASTM D412, ASTM D5712, ASTM F719-81, and ASTM F720-81. Sterile, disposable, single-use. ## Regulatory 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. ## Predicate Devices - Nutex Micro-Thin Surgical Gloves ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 | - 1 {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 K041437 ## 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:_ --- **Source:** [https://fda-staging.innolitics.com/device/K041437](https://fda-staging.innolitics.com/device/K041437) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com