(39 days)
This Sugeon's Glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.
NUZONE X2T, powderfree surgical glove meets the requirements for surgical gloves described by the American Standard for Testing and Material ASTM D 3577 - 01a²
The provided text describes a 510(k) submission for the NUZONE X2T Surgical Glove Powderfree. This is a medical device and the submission focuses on demonstrating substantial equivalence to a predicate device and adherence to established performance standards for surgical gloves.
Here's an analysis of the acceptance criteria and the study information as presented in the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance (NUZONE X2T) |
|---|---|
| Physical Properties: | |
| ASTM D 3577 - 01a (General | Meets the requirements for surgical gloves described by ASTM D 3577 - 01a. |
| requirements for surgical gloves) | |
| Biocompatibility: | |
| Primary Skin Irritation test | Indicates no irritation. |
| (ASTM F 719-81) | |
| Dermal Sensitization Test | Indicates no sensitization. |
| (ASTM F 720-81 (86)) | |
| FDA requirements | Meets FDA requirements. |
| Labeling claims | Meets labeling claims. |
| Substantial Equivalence | Substantially equivalent to the currently marketed devices (specifically the NUZONE X2 Neoprene - Polyisoprene synthetic powderfree surgical glove, K041436). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not explicitly state the sample sizes used for the specific tests (e.g., how many gloves were tested for physical properties, or how many subjects for skin irritation/sensitization). The "Brief description of non-clinical tests" section states, "Test conducted per ASTM D 3577 - 01ae2, ASTM D512 indicates that the product meet the requirements." This implies compliance with the sampling methods outlined in those ASTM standards, but the specific numbers are not provided.
- Data Provenance: The Submitter is "Terang Nusa Sdn Bhd" located in Kelantan, Malaysia. While the country of origin for the data is not explicitly stated, it is reasonable to infer that the tests were conducted or overseen by the Malaysian company or its affiliates. The document does not specify whether the data was retrospective or prospective, but given the nature of device testing for regulatory submission, it would typically be prospective testing conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is generally not applicable to the testing of surgical gloves for physical properties and biocompatibility. The "ground truth" for these tests is defined by the objective measurement criteria within the ASTM standards (e.g., tensile strength, elongation, barrier integrity) and the absence of a biological reaction in biocompatibility studies. There are no "experts" establishing a subjective "ground truth" in the way one would for diagnostic imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies or studies involving subjective assessments, where multiple readers might interpret data and a consensus or tie-breaking mechanism is needed. For standardized physical and biocompatibility testing, the results are typically objective measurements.
5. If a multireader multicase (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. MRMC studies are relevant for assessment of diagnostic accuracy, particularly with AI medical devices. This submission concerns a physical medical device (surgical gloves) and does not involve AI or human "readers" interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or an AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed is derived from:
- Objective Measurement Standards: The specifications and performance requirements outlined in ASTM D 3577 - 01a for surgical gloves. These define the acceptable ranges for physical properties like dimensions, physical integrity (e.g., absence of pinholes), and strength.
- Biological Endpoints: For biocompatibility tests (ASTM F 719-81 and ASTM F 720-81 (86)), the ground truth is the biological response, specifically the absence of primary skin irritation and dermal sensitization.
8. The sample size for the training set
Not applicable. The NUZONE X2T surgical glove is not an AI/Machine Learning device, so there is no "training set" in the context of algorithm development. The manufacturing process of the gloves could be considered "trained" through quality control and iterative process improvements, but this is not typically quantified as a "training set" in a regulatory submission context.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as point 8.
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Image /page/0/Picture/0 description: The image shows a compass rose with the letter N superimposed on it. The compass rose is a star-shaped figure with four points, each representing one of the cardinal directions. The letter N is placed in the center of the compass rose, and it is stylized with a bold, sans-serif font. The image is black and white, and it is likely a logo or symbol.
JUN 6 - 2005 TERANG NUSA Sdn Bhd
510(k) Submission for NUZONE X2T Surgical Glove Powderfree
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SPECIAL 510(k) Summary
| Submitter Name | Terang Nusa Sdn Bhd |
|---|---|
| Submitter Address | 1, Jalan 8Pengkalan Chepa 2 Industrial Zone16100 Kota Bharu,Kelantan, Malaysia. |
| Submitter Telephone | +60 9 7747171 |
| Submitter Fax | +60 9 7747757 |
| Contact Person | LOW, Chin Guan |
| Date of preparation | 22. April 2005 |
| Trade Name | NUZONE X2T |
| Common Name | Sterile Polychloroprene Synthetic surgical glove,Powderfree, Polymer coated Tan color. |
| Classification | Surgeon's Glove |
| Description of DeviceModification: | The NUZONE X2T, described in this SPECIAL510(k) is substantially equivalent to the NUZONEX2 Neoprene - Polyisoprene synthetic powderfreesurgical glove that is currently marketed andcleared under 510(K) number K041436. |
| Description of device | NUZONE X2T, powderfree surgical glove meetsthe requirements for surgical gloves described bythe American Standard for Testing and MaterialASTM D 3577 - 01a² |
| Intended Use of the device | NUZONE X2T surgical gloves are disposableand sterile devices intended to be worn byhealthcare personnel to prevent crosscontamination between the user and the patientduring procedures. |
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TERANG NUSA San Bhd
510(k) Submission for NUZONE X2T Surgical Glove Powderfree
のお気になる。
Comments of Children and Children and
September 1998 - 1999
510 K Summary ( continued)
| Brief description of non-clinical tests | Test conducted per ASTM D 3577 - 01ae2, ASTM D512 indicates that the product meet the requirements.Primary Skin Irritation test ASTM F 719-81 and Dermal Sensitization Test ASTM F 720-81 (86) 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 NUZONE X2T Polychloroprene synthetic powderfree 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 is a black and white logo for the Department of Health and Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around it. Inside the circle is a symbol of three stylized human figures facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 6 - 2005
Mr. Low Chin Guan Managing Director Terang NUSA Sdn Bhd 1 Jalan 8 Pengkalan Chepa 2 Industrial Zone Kota Bharu, 16100 MALAYSIA
Re: K051094
K031094
Trade/Device Name: Polychlorprene Synthetic Tan Surgical Glove Powder Free Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: May 17, 2005 Received: May 23, 2005
Dear Mr. Chin-Guan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed yoursely and have determined the device is substantially equivalent (for the referenced above and have acteriminosure) 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 Annehumens, or to do rood alla time ic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin uppression (the Act. The general controls provisions of the Act include controls provisions of the stration, 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 If your dovice is classified (been additional controls. Existing major regulations affecting (1 MA), it may of such adde of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or routish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Chin-Guan
Please be advised that FDA's issuance of a substantial equivalence determination does not Fleast be auvrsou that 1 Dr. determination that your device complies with other requirements mean that I DA mas made a decessand regulations administered by other Federal agencies. Of the Act of ally 1 ederal titled the equirements, including, but not limited to: registration 1 ou thust comply with an art are rabeling (21 CFR Part 801); good manufacturing practice and listing (21 CF R Part 807), aquality systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality sion 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) This letter will anow you to begin mains of substantial equivalence of your device to a premarket notification. The PDF innalis 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), If you desire specific at no for your at (240) 276-0115. 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 Inay other beloner beliefers, 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/industry/support/index.html.
Sincerely yours,
Shi-Jian Liu, Ph.D.
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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Indications for Use
510(k) Number (if known): K051094
Device Name: Polychlorprene Synthetic Tan Surgical Glove Powder Free
Indications For Use:
This Sugeon's Glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shila T. Murphy, MD 5/25/05
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
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510(k) Number: A051194
§ 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).