(129 days)
Not Found
No
The 510(k) summary describes a standard surgical glove and makes no mention of AI or ML technology.
No.
The "Intended Use" states it is "intended to be worn by operating room personnel to protect a surgical wound from contamination," which describes a preventative barrier, not a device used for treatment or therapy.
No
Explanation: A surgeon's glove is a protective barrier used during surgical procedures to prevent contamination. It does not perform any diagnostic function such as detecting, identifying, or monitoring a disease or condition.
No
The device is a surgical glove, which is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination by being worn by operating room personnel. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the material and standards for surgical gloves, not on any diagnostic capabilities.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
This device is clearly a surgical glove, which is a Class II medical device used for protection and barrier purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
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.
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
operating room personnel
Description of the training set, sample size, data source, and annotation protocol
Not Required
Description of the test set, sample size, data source, and annotation protocol
Not Required
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Brief description of non-clinical tests: Test conducted per ASTM D 3577 -- 01a2, ASTM D512 indicates that the product meet the requirements.
Testing to conform to the Primary Skin Irritation test ASTM F 719-81 and Dermal Sensitization Test ASTM F 720-81. Polyisoprene is not a primary skin irritant.
Brief description of clinical tests: Not required
Conclusion drawn from clinical and non clinical tests: It can be concluded that NUZONE SYNGARD Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove-Aloe Vera Coated Green Colour glove will perform according to the performance standards referenced and therefore meets ASTM standards. FDA requirements and labeling claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows a compass rose with the letter N superimposed on each of the four cardinal directions. The compass rose is a star shape with eight points. The letter N is in a sans-serif font and is white with a black outline. The compass rose is black and white.
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.
1
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-clinical
tests | Test conducted per ASTM D 3577 -- 01a°2, ASTM
D512 indicates that the product meet the
requirements. |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Testing to conform to the Primary Skin Irritation
test ASTM F 719-81 and Dermal Sensitization Test
ASTM F 720-81. Polyisoprene is not a primary
skin irritant. |
| Brief description of clinical tests | Not required |
| Conclusion drawn from clinical and
non clinical tests | It can be concluded that NUZONE SYNGARD
Powder Free Polymer Coated Polyisoprene Sterile
Surgical Glove-Aloe Vera Coated Green Colour
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 |
:
2
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.
3
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
4
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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