(39 days)
No
The document describes a standard surgical glove and references performance standards for physical properties and biocompatibility, with no mention of AI or ML.
No
The device is a surgical glove, which is intended to protect a surgical wound from contamination and protect operating room personnel. It is not used to treat or diagnose a disease or condition in a patient.
No
Explanation: The device is a surgical glove intended to protect a surgical wound and operating room personnel from contamination, and it does not perform any diagnostic function.
No
The device is a surgical glove, which is a physical hardware device made of synthetic rubber, 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 samples taken from the body.
- Device Description: The description focuses on the material and standards for surgical gloves (ASTM D 3577).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical glove does not fit that description.
N/A
Intended Use / Indications for Use
NUZONE X2T 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.
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.
Product codes
KGO
Device Description
The NUZONE X2T, described in this SPECIAL 510(k) is substantially equivalent to the NUZONE X2 Neoprene - Polyisoprene synthetic powderfree surgical glove that is currently marketed and cleared under 510(K) number K041436. NUZONE X2T, powderfree surgical glove meets the requirements for surgical gloves described by the American Standard for Testing and Material ASTM D 3577 - 01a²
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
healthcare personnel, operating room personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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 8 |
| Pengkalan Chepa 2 Industrial Zone | |
| 16100 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 Device | |
| Modification: | The NUZONE X2T, described in this SPECIAL |
| 510(k) is substantially equivalent to the NUZONE | |
| X2 Neoprene - Polyisoprene synthetic powderfree | |
| surgical glove that is currently marketed and | |
| cleared under 510(K) number K041436. | |
| Description of device | NUZONE X2T, powderfree surgical glove meets |
| the requirements for surgical gloves described by | |
| the American Standard for Testing and Material | |
| ASTM D 3577 - 01a² | |
| Intended Use of the device | NUZONE X2T 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
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 |
2
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.
3
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