(111 days)
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.
MAXITEX NEURO PF, powderfree surgical glove meets the requirements for surgical gloves described by the American Standard for Testing and Material ASTM D3577-01a2.
The device described in the 510(k) summary is the MAXITEX NEURO PF (Sterile surgical glove, Powderfree). It is a surgical glove, and its performance is evaluated against established industry standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D3577-01a2 (Surgical Gloves) | Meets the requirements for surgical gloves. |
| ASTM D412 (Rubber Properties in Tension) | Test indicates the product meets the requirements. |
| ASTM D5712 (Protein Content) | Contains less than 50 micrograms/gram of water extractable protein. |
| ASTM F719-81 (Primary Skin Irritation) | Indicates no sensitization or irritation. |
| ASTM F720-81 (Dermal Sensitization) | Indicates no sensitization or irritation. |
| FDA requirements | Meets FDA requirements. |
| Labeling claims | Meets labeling claims. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" sample size for each performance test. The tests are general compliance tests for the product type.
- Data Provenance: Not explicitly stated, but the submission is from Terang Nusa Sdn Bhd, a company in Malaysia. The tests refer to ASTM standards, which are international.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for the performance of these surgical gloves is established by compliance with the referenced ASTM standards, which define acceptable physical properties and biological responses. These are objective performance measures, not subjective interpretations by experts in the context of ground truth for AI/diagnosis.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The evaluation is based on objective measurements and comparison to predefined thresholds in the ASTM standards, not subjective adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This is not applicable as the device is a surgical glove, not an AI or diagnostic tool that involves human readers interpreting cases.
6. Standalone Performance Study
- Standalone Performance Study Done: Yes, in the sense that the device's technical specifications and physical properties were tested in isolation against the ASTM standards. The "Brief description of non-clinical tests" highlights these tests conducted per ASTM D3577-01ae2, ASTM D 412, and ASTM D5712.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth is primarily based on predetermined performance standards and specifications outlined in ASTM (American Society for Testing and Materials) standards. This includes physical properties (e.g., tensile strength from ASTM D412), protein content (ASTM D5712), and biocompatibility/irritation tests (ASTM F719-81, ASTM F720-81).
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. Surgical glove manufacturing and testing do not involve a "training set" in the context of machine learning or AI models. The manufacturing process is designed to consistently produce gloves meeting the specifications, and samples are taken for quality control and compliance testing.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in this context. The manufacturing processes and quality control systems are designed to ensure adherence to the established ASTM standards and internal specifications.
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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 8Pengkalan Chepa 2 Industrial Zone16100 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 lessthan 50 microgram / gram of water extractableprotein. |
| Classification | Surgeon's Glove |
| Legally marketed device to whichsubstantial equivalence is beingclaimed. | The MAXITEX NEURO PF, described in this510(k) is substantially equivalent to the NutexMicro-Thin Surgical Gloves that is currentlymarketed. |
| Description of device | MAXITEX NEURO PF, powderfree surgicalglove meets the requirements for surgical glovesdescribed by the American Standard for Testingand Material ASTM D3577-01a2. |
| Intended Use of the device | MAXITEX NEURO PF surgical gloves aredisposable and sterile devices intended to be wornbyhealthcare personnel to prevent crosscontamination between the user and the patientduring procedures. |
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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-clinicaltests | Test conducted per ASTM D3577-01ae2, ASTMD 412, ASTM D5712 indicates that the productmeet the requirements.Primary Skin Irritation test ASTM F 719-81 andDermal Sensitization Test ASTM F 720-81 (2002)indicates no sensitization or irritation. |
|---|---|
| Brief description of clinical tests | Not required |
| Conclusion drawn from clinical andnon clinical tests | It can be concluded that MAXITEX NEURO PFsurgical glove will perform according to theperformance standards referenced and thereforemeets ASTM standards., FDA requirements andlabeling claims.This device is substantially equivalent to thecurrently marketed devices. |
| Additional information deemednecessary 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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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:_
§ 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).