(257 days)
Not Found
No
The device is a surgical glove and the summary does not mention any AI/ML components or functions.
No.
This device is a surgical glove intended for protection and prevention of cross-contamination, not for treating a disease or condition.
No
The device is a surgical glove, intended to protect from contamination, not to diagnose a condition.
No
The device is a physical product (surgical gloves) and the summary describes material properties, sterilization, and physical performance tests, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to be worn by operating room personnel to protect a surgical wound from contamination." This describes a barrier device used during a medical procedure, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and sterilization of a surgical glove.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information
- Using reagents or assays
The device is a medical device, specifically a surgical glove, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Motex Powdered Nitrile Surgical Gloves are sterile disposable devices 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
Motex Powdered Nitrile Surgical Gloves are made of synthetic rubber. They are sterilized by radiation, and intended to be used in surgery to prevent the cross contamination between patient and user.
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 Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison to ASTM and ISO standards for:
- Dimensions (ASTM D3577-09e1)
- Physical Properties (ASTM D3577-09e1)
- Freedom from Holes (ASTM D3577-09e1)
- Water leak testing (ASTM D5151-06)
- Residual powder testing (ASTM D6124-06)
- Water extractable protein testing (ASTM D5712-10)
- Biocompatibility (ISO 10993-10:2010, ISO 10993-12:2007)
- Sterilization Validation (ISO 11137-1:2006, ISO 11137-2:2006)
Biocompatibility Test Reports:
- Skin Sensitization Test (Maximization test), Sesame oil extract;
- Skin Sensitization Test (Maximization test), Sodium Chloride extract;
- Skin Irritation Test, Sesame oil extract;
- Skin Irritation Test, Sodium Chloride extract;
Results show that the Motex Powdered Nitrile Surgical Gloves are safe for their intended use, are not an irritant, and not a sensitizer.
Powder Residual:
Meets powder level requirements for "Powder" designation per ASTM D6124-06. Results generated values below 15mg/dm2 of residual powder per glove.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Values below 15mg/dm2 of residual powder per glove.
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
SHANGHAI MOTEX HEALTHCARE CO., LTD.
No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: 86-21-5979 9888 Fax: 86-21-23010718
MAY 2 1 2014
II. 510(K) Summary of Safety and Effectiveness (Per 21 CFR 807.92)
2.1. General Information Establishment
- I Manufacturer: Shanghai Motex Healthcare Co., Ltd.
- Address: No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China .
- 그 Owner Number: 9041164 Registration Number: 9615978
- Contact Person: Dr. Jen, Ke-Min E-mail: ceirs.jen@msa.hinet.net Tel: +886-3-5208829 ; Fax: +886-3-5209783
- Date Prepared: May 20, 2014
Device
- Proprietary Name: Motex Powdered Nitrile Surgical Gloves, Item 6010 White Motex Powdered Nitrile Surgical Gloves, Item 6010 Green
- . Common Name: Surgeon's glove
- . Surgeon's Gloves Classification Name:
- . Product Code: KGO
● Regulation Number: Class I, 878.4460
2.2. Safety and Effectiveness Information
● Predicate Device:
Claim of Substantial Equivalence (SE) is made to NUZONE Nitrile Powdered Surgical Gloves (K000178)
● Device Description:
Motex Powdered Nitrile Surgical Gloves are made of synthetic rubber. They are sterilized by radiation, and intended to be used in surgery to prevent the cross contamination between patient and user.
. Indications for Use:
The Motex Powdered Nitrile Surgical Gloves are sterile disposable devices 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.
. Device Characteristics:
Single use only. Not made with natural rubber latex.
1
No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: 86-21-5979 9888 Fax: 86-21-23010718
● Technological Characteristics:
Motex Powdered Nitrile Surgical Gloves characteristics are summarized below compared to ASTM and ISO standards to the predicate device:
| Characteristic | Standard |
|---|---|
| Dimensions | ASTM D3577-09e1 |
| Physical Properties | ASTM D3577-09e1 |
| Freedom from Holes | ASTM D3577-09e1 |
| Water leak testing | ASTM D5151-06 |
| Residual powder testing | ASTM D6124-06 |
| Water extractable protein testing | ASTM D5712-10 |
| Biocompatibility | ISO 10993-10:2010 |
| ISO 10993-12:2007 | |
| Sterilization Validation | ISO 11137-1:2006 |
| ISO 11137-2:2006 |
● Powder Residual:
Surgeon's gloves meet powder level requirements for "Powder" designation per ASTM D6124-06, Standard test method for residual powder on medical gloves. The results generated values will below 15mg/dm2 of residual powder per glove.
. Biocompatibility Test Reports:
According to ISO 10993 series standards, we completed the biological evaluation and the results of these studies show that the Motex Powdered Nitrile Surgical Gloves safe for their intended use. Besides, we also completed the following reports for each item 6010_White and 6010_Green including:
- Skin Sensitization Test (Maximization test), Sesame oil extract;
- . Skin Sensitization Test (Maximization test), Sodium Chloride extract;
- � Skin Irritation Test, Sesame oil extract;
- Skin Irritation Test, Sodium Chloride extract;
. Clinical Data:
Not applicable.
2
SHANGHAI MOTEX HEALTHCARE CO., LTD.
No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China
Telephone: 86-21-5979 9888 Fax: 86-21-23010718
Comparison Table
| Similarity: | |||
|---|---|---|---|
| Comparison Feature | Predicate device | Subject device | |
| Device name | Nuzone Nitrile Surgical Gloves, | ||
| Powdered, Green | |||
| (K000178) | Motex Powdered Nitrile Surgical | ||
| Gloves | |||
| (K132802) | |||
| Indications For Use | The surgical glove is a device made | ||
| of synthetic rubber intended to be | |||
| worn by operating room personnel | |||
| to protect a surgical wound from | |||
| contamination. | The Motex Powdered Nitrile | ||
| Surgical Gloves are sterile | |||
| disposable devices 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/OTC | |||
| Device | Over-the-Counter Use | Over-the-Counter Use | |
| Product code | KGO, Class I, 878.4460 | KGO, Class I, 878.4460 | |
| Device Design | They are coated with nitrile coating | ||
| and are offered powdered and | |||
| sterile. | They are coated with nitrile coating | ||
| and are offered powdered and | |||
| sterile. | |||
| Major Material | |||
| Composition | Nitrile and | ||
| Absorbable dusting powder | |||
| . - | Nitrile: Acrylonitrile- butadiene | ||
| rubber latex; i.e. NBR | |||
| (CASH | |||
| 9003-18-3) | |||
| Absorbable dusting powder USP | |||
| (FDA PMA Number: P890070) | |||
| Performance Test | |||
| for Pinhole, | |||
| Dimensions, and | |||
| Physical properties | Meets ASTM D3577-09 | Meets ASTM D3577-09 | |
| Biocompatibility | Primary Skin irritation test | ||
| ASTM F 719-81 and Dermal | |||
| Sensitization Test ASTM | |||
| F720-81, indicates "under the | |||
| conditions of the study, not an | |||
| irritant" and "under | |||
| conditions of the study, not a | |||
| sensitizer. " | Meets ISO 10993-10:2010/ | ||
| ISO 10993-12:2007 | |||
| Gloves are "under the conditions | |||
| of the study, not an irritant" and | |||
| "under conditions of the study, | |||
| not a sensitizer. " | |||
| Sterilization Validation | Sterile Nitrile Powdered Surgical | ||
| Gloves | Meets ISO 11137-1:2006, | ||
| ISO 11137-2:2006 | |||
| Powder Residual | N/A | Meets ASTM D6124-06 | |
| Results generated values below | |||
| 15mg/dm² of residual powder per | |||
| glove | |||
| Water Extractable | |||
| Protein Testing | N/A | Meets ASTM D5712-10 |
3
SHANGHAI MOTEX HEALTHCARE CO., LTD.
No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: 86-21-5979 9888 Fax: 86-21-23010718
Difference:
| Product Trade Name | Nuzone Nitrile Surgical Gloves,
Powdered, Green | Motex Powdered Nitrile Surgical
Gloves
6010 White and 6010 Green |
|--------------------|----------------------------------------------------|--------------------------------------------------------------------------|
| Specification size | N/A | 6, 6.5, 7, 7.5, 8, 8.5 |
. Substantial Equivalence (SE)
A claim of substantial equivalence is made to NUZONE Nitrile Powdered Surgical Gloves (K000178). Both of the subject device and predicate device are the same Powdered Surgical Gloves which have the similar indications for use. material composition with Nitrile, meet the performance tests by ASTM D3577-09, and also completed the biocompatibility, sterilization validation test reports. The major differences of the two devices are the different colorants and specification. That just means the subject devices have two colorants: white and green, and the predicate device has only one green colorant; and the specifications of the subject device are limited on the 6~8.5 sizes. These differences are not relating to the safety or effectiveness aspects. Thus they are substantially equivalent.
4
Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three abstract shapes instead of snakes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
May 21, 2014
Shanghai Motex Healthcare Company, Limited C/O Dr. Ke-Min Jen Official Correspondent No. 369, Jiasong Zhong Road Huaxin, Oingpu, Shanghai CHINA 201708
Re: K132802
Trade/Device Name: Motex Powdered Nitrile Surgical Gloves, Item 6010 White Motex Powdered Nitrile Surgical Gloves, Item 6010 Green Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class; 1 Product Code: KGO Dated: April 19, 2014 Received: April 24, 2014
Dear Dr. Jen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
Page 2 - Dr. Jen
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/Medica|Devices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132802
Davice Name
Motex Powdered Nitrile Surgical Gloves, Item 6010 White Motex Powdered Nitrile Surgical Gloves, Item 6010 Green
Indications for Use (Describe)
The Motex Powdered Nitrile Surgical Gloves are sterile disposable devices 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.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sreekanth Gutala
Digitally signed by Sreekanth Gutala -S
DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000540490, cn=Sreekanth Gutala -S Date: 2014.05.21 12:28:53 -04'00'
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