(129 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.
NUZONE SYNGARD, powderfree surgical glove meets the requirements for surgical gloves described by the American Standard for Testing and Material ASTMID 3577 - 01a-2.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NUZONE SYNGARD Surgical Glove:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Device Performance |
|---|---|
| Physical Properties | |
| ASTM D 3577 - 01a-2 | The device "meets the requirements for surgical gloves described by the American Standard for Testing ASTM D 3577 - 01a-2." Specifically, it "meets the requirements" of ASTM D 3577 - 01a-2 and ASTM D512 (though D512 is not explicitly detailed as an acceptance criteria, it's mentioned in conjunction with D3577 requirements). The conclusion states it "will perform according to the performance standards referenced and therefore meets ASTM standards." |
| Biocompatibility | |
| ASTM F 719-81 (Primary Skin Irritation) | The device was subjected to "Testing to conform to the Primary Skin Irritation test ASTM F 719-81." The result is that "Polyisoprene is not a primary skin irritant." |
| ASTM F 720-81 (Dermal Sensitization) | The device was subjected to "Testing to conform to the...Dermal Sensitization Test ASTM F 720-81." The result is implicitly that it does not cause dermal sensitization, as the overall conclusion states it meets FDA requirements which include biocompatibility. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for any of the described tests (ASTM D 3577-01a-2, ASTM F 719-81, ASTM F 720-81).
The data provenance is not explicitly stated in terms of country of origin for the testing itself, but the submission is from Malaysia. The tests are based on American Society for Testing and Materials (ASTM) standards. The nature of the tests (physical properties and biocompatibility) suggests they were conducted on samples of the manufactured device.
The study is retrospective in the sense that the tests were performed on finished products before submission, rather than as part of an ongoing clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the data presented. The tests described are laboratory-based physical and biocompatibility assessments against established industry standards (ASTM). They do not involve expert interpretation or ground truth establishment in the way clinical studies with human participants or imaging data would. The "ground truth" for these tests is defined by the parameters and methodologies outlined in the respective ASTM standards themselves.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are objective, laboratory-based measurements against pre-defined ASTM standards. There is no mention of subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (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
This information is not applicable. The device is a surgical glove, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a surgical glove, not an algorithm or software. Standalone performance for an algorithm is not relevant.
7. The Type of Ground Truth Used
The ground truth used for the device's performance assessment is based on regulatory and industry standards (ASTM) for physical properties and biocompatibility (skin irritation and sensitization). These standards define acceptable ranges and methodologies for determining whether a surgical glove performs as intended and is safe for use.
8. The Sample Size for the Training Set
This information is not applicable. As a physical medical device (surgical glove), there is no "training set" in the context of machine learning or AI. The product is manufactured and then tested to ensure it meets pre-defined quality and safety standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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K05/562
TERANG NUSA Sdn Bhd
510(k) Submission for NUZONE SYNGARI) Surgical Glove Powderfree
510(k) Summary
Submitter Name
Submitter Address
Terang Nusa Sdn Bhd
1 . Jalan 8 Pengkalan Chepa 2 Industrial Zone 16100 Kota Bharu, Kelantan . Malaysia.
Submitter Telephone
Submitter Fax
Contact Person
Date of preparation
Trade Name
Common Name
Classification
Legally marketed device to which substantial equivalence is being claimed.
Description of device
Intended Use of the device
160 9 7747171
+60 9 7747757
LOW . Chin Guan
May 19, 2004
NUZONE SYNGARD
Powder Free Polymer Coated Poly isoprene Sterile Surgical Glove-Aloe Vera Coated Green Colour.
Surgeon's Glove
The NUZONE SYNGARD, described in this 510(k) is substantially equivalent to the Aloe Touch powder free polymer coated polvisoprene surgical gloves, sterile, coated with aloe ver, Natural colour or turquoise (blue/green) colour that is currently marketed under 510K No. K040503.
NUZONE SYNGARD, powderfree surgical glove meets the requirements for surgical gloves described by the American Standard for Testing ASTMID 3577 - 01a-2. and Material
SYNGARD surgical gloves are NUZONE disposable and sterile devices intended to be worn by healtheare personnel to prevent cross contamination between the user and the patient during procedures.
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Image /page/1/Picture/0 description: The image shows a compass rose with two overlapping letter N's. The compass rose has four points, and the letter N's are placed on top of the compass rose. The letter N's are stylized and have a rounded shape. The image is black and white.
:
TERANG NUSA Sdn Bhd
510(k) Submission for NUZONE SYNGARD Surgical Glove Powderfree
510 K Summary ( continued)
| Brief description of non-clinicaltests | Test conducted per ASTM D 3577 -- 01a°2, ASTMD512 indicates that the product meet therequirements. |
|---|---|
| Testing to conform to the Primary Skin Irritationtest ASTM F 719-81 and Dermal Sensitization TestASTM F 720-81. Polyisoprene is not a primaryskin irritant. | |
| Brief description of clinical tests | Not required |
| Conclusion drawn from clinical andnon clinical tests | It can be concluded that NUZONE SYNGARDPowder Free Polymer Coated Polyisoprene SterileSurgical Glove-Aloe Vera Coated Green Colourglove will perform according to the performancestandards referenced and therefore meets ASTMstandards. FDA requirements and labeling 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three horizontal lines below the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 0 2005
Mr. Chin-Guan Low Managing Director TERANG NUSA SDN BHD 1. Jalan 8, Pengkalan Chepa 2 Industrial Zonc Kota Bharu, Kelantan MALAYSIA 16100
Re: K051562
KUJ1502
Trade/Device Name: NUZONE SYNGARD Powder Free Polymer Coated Polyisoprene
Trade/Device Name: NUZONE SYNGARD Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove Aloe Vera Coated Green Colour Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: September 27, 2005 Received: October 5, 2005
Dear Mr. Low:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became in 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 cnactment date of the Medical Device Interstate commerce pror to that have been reclassified in accordance with the provisions of Amendinens, of to devrees mat martic Act (Act) that do not require approval of a premarket the rederal Pood, Drug, and Ocometto , therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the rec. "The girls 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 device is classified (500 additional controls. Existing major regulations affecting (PMA), It may be subject to have adata frederal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Sous nouncements 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 Please be advised that I DA 3 issualled on that your device complies with other requirements mean that I DA has made a determinations administered by other Federal agencies. of the Act of ally i ederal statues and regisments, including, but not limited to: registration You must comply with an the Fict b rog 21 CFR Part 801); good manufacturing practice and ilsung (21 CFR Part 607), labeling (21 CFR Part 820); and if requirents as set form in the quarty of closed on (S) (Sections 531-542 of the Act); applicable, the clectionic product laulow you to begin marketing your device as described 21 CFK 1000-1030. This letter will and would be of substantial equivalence In your Section 910(x) promative no oredicate 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), If you desire specific advice for Jour de at (240) 276-0115. Also, please note the regulation prease contact the Other or Somments to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Inay other general mironmentoners, International and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sydtie y. Michie Omd.
Chu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K051562
Device Name: Powder Free Polymer Coated Polyisoprene sterile surgical Glove Aloe vera coated green colour. 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.
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)
Cat. Aid-for Hurricane Katrina 10/7/05
Division of Anesthesiology, General Hospital, Intection Control, Dental Devices
510(k) Number:
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§ 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).