(257 days)
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.
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.
This is a medical device submission for a surgical glove, not an AI/ML powered device. As such, the requested information regarding AI/ML study design and performance criteria is not applicable.
The device, Motex Powdered Nitrile Surgical Gloves, is seeking substantial equivalence to a predicate device (NUZONE Nitrile Powdered Surgical Gloves) based on meeting established performance standards for surgical gloves.
Here's a breakdown of the requested information, adapted for a non-AI medical device:
1. Table of Acceptance Criteria and Reported Device Performance
This device's performance is demonstrated by meeting recognized industry standards.
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D3577-09e1 | Meets ASTM D3577-09 |
| Physical Properties | ASTM D3577-09e1 | Meets ASTM D3577-09 |
| Freedom from Holes | ASTM D3577-09e1 | Meets ASTM D3577-09 |
| Water leak testing | ASTM D5151-06 | Meets ASTM D3577-09 (Implied by meeting D3577-09 which includes this) |
| Residual powder testing | ASTM D6124-06 | Results generated values below 15mg/dm² of residual powder per glove (Meets standard) |
| Water extractable protein testing | ASTM D5712-10 | Meets ASTM D5712-10 |
| Biocompatibility | ISO 10993-10:2010 | Meets ISO 10993-10:2010 |
| ISO 10993-12:2007 | Meets ISO 10993-12:2007 | |
| Sterilization Validation | ISO 11137-1:2006 | Meets ISO 11137-1:2006 |
| ISO 11137-2:2006 | Meets ISO 11137-2:2006 | |
| Skin Sensitization Test | (Part of ISO 10993-10) | Not a sensitizer |
| Skin Irritation Test | (Part of ISO 10993-10) | Not an irritant |
2. Sample size used for the test set and the data provenance
The document specifies performance testing against ASTM and ISO standards. These standards typically specify their own sampling plans and test methodologies. The document does not provide the specific sample sizes used for each test (e.g., number of gloves tested for pinholes, physical properties).
- Data Provenance: The tests were conducted by the manufacturer, Shanghai Motex Healthcare Co., Ltd. (China). The document does not explicitly state whether the tests were retrospective or prospective, but based on the context of a 510(k) submission, they would typically be prospective tests performed on representative samples of the manufactured devices to demonstrate compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable for this type of medical device. "Ground truth" in the context of expert consensus is typically relevant for interpretative tasks (e.g., image analysis, diagnosis) often associated with AI/ML systems. For surgical gloves, compliance with physical, chemical, and biological standards is determined by laboratory testing and measurements, not by expert consensus on an "answer."
4. Adjudication method for the test set
Not applicable for this type of medical device. Adjudication methods like 2+1 or 3+1 refer to how multiple expert opinions are resolved to establish a single "ground truth," which is not relevant for objective laboratory measurements against predefined standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, this was not done. MRMC studies are specific to evaluating the diagnostic performance of readers (human or AI) on cases, particularly in imaging, and are not relevant for the evaluation of a surgical glove's physical and biological properties. There is no "human reader" component in assessing a surgical glove's compliance with ASTM/ISO standards.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a surgical glove, not an algorithm. Therefore, "standalone algorithm performance" is not a concept that applies here.
7. The type of ground truth used
The "ground truth" for this device's performance is established by objective, quantitative measurements and laboratory tests defined within internationally recognized standards (ASTM, ISO). For example:
- Physical properties (e.g., tensile strength, elongation): Measured values are compared against minimum/maximum thresholds specified in ASTM D3577-09.
- Freedom from holes: Determined by water leak testing (ASTM D5151-06), where the "ground truth" is whether a glove leaks or not under specified pressure for a given duration.
- Residual powder: Measured directly and compared against the 15mg/dm² threshold from ASTM D6124-06.
- Biocompatibility: Determined by the results of specific in-vitro and in-vivo tests (e.g., skin irritation, sensitization) that follow ISO 10993 series standards, where the "ground truth" is the observation of a biological response (or lack thereof) compared to control or reference materials.
- Sterilization: Validated by adherence to ISO 11137 series standards, ensuring a specified sterility assurance level (SAL).
8. The sample size for the training set
Not applicable. This device is not an AI/ML system, so there is no concept of a "training set" in the machine learning sense. The device is manufactured according to specifications and then tested against standards, not "trained" on data.
9. How the ground truth for the training set was established
Not applicable for the same reasons as #8.
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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.
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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.
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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 SurgicalGloves(K132802) | |
| Indications For Use | The surgical glove is a device madeof synthetic rubber intended to beworn by operating room personnelto protect a surgical wound fromcontamination. | The Motex Powdered NitrileSurgical Gloves are steriledisposable devices made ofsynthetic rubber intended to be wornby operating room personnel toprotect a surgical wound fromcontamination. The lubricating ordusting powder used in the glove isexcluded. | |
| Prescription/OTCDevice | 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 coatingand are offered powdered andsterile. | They are coated with nitrile coatingand are offered powdered andsterile. | |
| Major MaterialComposition | Nitrile andAbsorbable dusting powder. - | Nitrile: Acrylonitrile- butadienerubber latex; i.e. NBR(CASH9003-18-3)Absorbable dusting powder USP(FDA PMA Number: P890070) | |
| Performance Testfor Pinhole,Dimensions, andPhysical properties | Meets ASTM D3577-09 | Meets ASTM D3577-09 | |
| Biocompatibility | Primary Skin irritation testASTM F 719-81 and DermalSensitization Test ASTMF720-81, indicates "under theconditions of the study, not anirritant" and "underconditions of the study, not asensitizer. " | Meets ISO 10993-10:2010/ISO 10993-12:2007Gloves are "under the conditionsof the study, not an irritant" and"under conditions of the study,not a sensitizer. " | |
| Sterilization Validation | Sterile Nitrile Powdered SurgicalGloves | Meets ISO 11137-1:2006,ISO 11137-2:2006 | |
| Powder Residual | N/A | Meets ASTM D6124-06Results generated values below15mg/dm² of residual powder perglove | |
| Water ExtractableProtein Testing | N/A | Meets ASTM D5712-10 |
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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 SurgicalGloves6010 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.
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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.
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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
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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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§ 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).