(608 days)
No
The summary describes surgical gloves and their physical properties and testing, with no mention of AI or ML.
No
Surgical gloves are barrier devices intended for protection from contamination, not for treating a disease or condition.
No
The device is a surgical glove, intended to protect a surgical wound from contamination and prevent cross-contamination, not to diagnose a condition.
No
The device description clearly states it is made of synthetic rubber and is a physical glove, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn by operating room personnel to protect a surgical wound from contamination. This is a barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the material (synthetic rubber), sterilization method, and physical properties of the gloves. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for diagnosis, monitoring, or screening
This device is clearly a surgical glove, which is a medical device used for protection and hygiene during surgical procedures.
N/A
Intended Use / Indications for Use
MOTEX Polyisoprene Powder-Free Sterile Surgical Gloves are powder-free surgeon's glove 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 Powder-free Polyisoprene Surgical Sterile Gloves, Model # 6412 Nature, 6412_Blue; 6512_Nature, 6512_Blue are made of synthetic rubber. The sterile gloves are sterilized by the radiation method. 6412 Nature, 6412 Blue are of thin gloves. 6512 Nature, 6512 Blue are of thick gloves. They are processed by special treatment with no protein, and intended to be used in surgery to prevent the cross contamination between patients and users.
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)
Non-clinical tests were conducted. The device demonstrates safety and effectiveness comparable to the predicate device. Key results include:
- Dimensions: meets ASTM D 3577-09
- Physical Properties: meets ASTM D 3577-09
- Freedom from Holes: meets ASTM D 3577-09
- Residual powder testing: meets ASTM D 6124-06 (Reaffirmation 2011)
- Water leak testing: meets ASTM D 5151-06 (Reapproved 2011)
- Water extractable protein testing: meets ASTM D 5712-10
- Biocompatibility: non irritant & non- sensitizing, ISO10993-10:2010, ISO10993-12:2012
- Sterilization Validation: Pass ISO11137-1:2006 (Amendment 1:2013), ISO11137-2:2013
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Powder Residual: The results generated values will be below 2mg of residual powder per glove.
Predicate Device(s)
Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves (K093300)
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 HEATHCARE CO., LTD.
No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: 86-21-5979 9888 Fax: 86-21-23010718
II. 510(K) Summary of Safety and Effectiveness (Per 21 CFR 807.92)
JUN 0 4 2014
2.1. General Information Establishment
- Manufacturer: Shanghai Motex Healthcare Co., Ltd.
- 특 Address: No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China
- 그 Owner Number: 9041164 Registration Number: 9615978
- 를 Contact Person: Dr. Jen, Ke-Min E-mail: ceirs.jen@msa.hinet.net Tel: +886-3-5208829 : Fax: +886-3-5209783
- 그 May 23, 2014 . Date Prepared:
Proprietary Name:
Subject Device:
- MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Nature MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Blue MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Nature MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Blue
| • Common Name: | Surgeon's glove |
|---|---|
| ---------------- | ----------------- |
- . Classification Name: Surgeon's Gloves
- Product Code: KGO, Class I
- Regulation Number: 878.4460
- Predicate device:
- . Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves (K093300)
2.2. Safety and Effectiveness Information
-
Predicate Device:
Claim of Substantial Equivalence (SE) is made to Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves (K093300) -
Device Description:
Motex Powder-free Polyisoprene Surgical Sterile Gloves, Model # 6412 Nature, 6412_Blue; 6512_Nature, 6512_Blue are made of synthetic rubber. The sterile gloves are sterilized by the radiation method. 6412 Nature, 6412 Blue are of thin gloves. 6512 Nature, 6512 Blue are of thick gloves. They are processed by special treatment with no protein, and intended to be used in surgery to prevent the cross contamination between patients and users.
1
No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: +86-21-5979 9888 Fax: +86-21-23010718
Motex Polyisoprene Powder-free Surgical Gloves variant models
| Model | Size | Product Description | Size | |||||
|---|---|---|---|---|---|---|---|---|
| Hand shape | Surface | Beaded cuff | Sterile | Color | Length (min) | Thickness (min) | ||
| 6412 | 6, 6.5, 7, 7.5, 8, 8.5 | |||||||
| (Sterile) | Curved Finger | Textured | • | • | Nature Blue | $280\pm6$ mm | $0.13\pm0.03$ mm | |
| 6512 | 6, 6.5, 7, 7.5, 8, 8.5 | |||||||
| (Sterile) | Curved Finger | Textured | • | • | Nature Blue | $280\pm6$ mm | $0.15\pm0.03$ mm |
● Indications for Use:
MOTEX Polyisoprene Powder-Free Sterile Surgical Gloves are powder-free surgeon's glove 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:
a. Single use only.
b. Not made with natural rubber latex.
● Powder Residual:
Surgeon's gloves meet powder level requirements for Powder-free" designation per ASTM D6124-06 (Reaffirmation 2011), Standard test method for residual powder on medical gloves.
The results generated values will be below 2mg of residual powder per glove.
● Biocompatibility Test Reports:
There are complied with the biological evaluation and the results of these studies show that the MOTEX Polyisoprene Powder-free Sterile Surgical Glove safety for its intended use, including:
- � Systemic Intravenous Injection
- Systemic Intraperitoneal Injection
- Skin Sensitization Test (Maximization test), Sesame oil extract;
- . Sensitization Test (Maximization test), Sodium Chloride extract;
- Skin Irritation Test, Sesame oil extract;
- Skin Irritation Test, Sodium Chloride extract;
2
No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: +86-21-5979 9888 Fax: +86-21-23010718
- Clinical Data:
Not applicable.
Comparison between the subject devices and the predicate device ●
| Feature | Predicate device | Subject device |
|---|---|---|
| Proprietary name | Esteem SMT Polyisoprene | |
| Powder-Free Surgical Sterile | ||
| Gloves | Motex Powder-free Polyisoprene | |
| Surgical Gloves | ||
| 510(k) number | K093300 | K123126 |
| Model | SMT | 6412 (nature, blue) |
| 6512 (nature, blue) | ||
| Indications For Use | Powder-Free Polyisoprene Surgical | |
| Gloves are sterile disposable | ||
| devices made of imported synthetic | ||
| rubber intended to be worn by | ||
| operating room personnel to | ||
| protect a surgical wound from | ||
| contamination in the environments | ||
| within hospitals and other | ||
| healthcare facilities. | MOTEX Polyisoprene Powder-Free | |
| Sterile Surgical Gloves are | ||
| powder-free surgeon's glove 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 | KGO |
| Classification | Class I | Class I |
| Regulation number | 878.4460 | 878.4460 |
| Manufacturing | ||
| material | Synthetic Polyisoprene | Synthetic Polyisoprene |
| Specifications | ||
| Size | N/A | Size: 6, 6.5, 7, 7.5, 8, 8.5 |
| Length (mm) | N/A | $280\pm6$ |
| Width (mm) | N/A | size 6--77, size 6.5--84, |
| size 7--91, size 7.5--98, | ||
| size 8--102, size 8.5-108 | ||
| Thickness (finger, | ||
| palm, cuff) (mm) | N/A | (6412)— |
| $0.13\pm0.03$ , | ||
| $0.13\pm0.03$ | ||
| (6512)— | ||
| $0.15\pm0.03$ , | ||
| $0.15\pm0.03$ | ||
| Tensile strength | ||
| (before and after | ||
| aging), | N/A | Before aging: 24 Mpa |
| After aging: 23 Mpa | ||
| ultimate elongation | ||
| (%) (before and after | ||
| aging) | N/A | Before aging : 929% |
| After aging : 879% | ||
| Test for Pinhole, | ||
| Dimensions, and | ||
| Physical properties | Meets ASTM D3577-09 | Meets ASTM D3577-09 |
| Residual powder | ||
| testing | Meets ASTM D 6124-06 | |
| Residual powder Dr. Jen, Ke-Min 510(k) correspondent person for Shanghai Motex Healthcare Co., Ltd. |
5
Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure, with three overlapping profiles suggesting community and connection. The overall design is simple and conveys a sense of unity and service.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 18 2014
Shanghai Motex Healthcare Co., Ltd Dr. Jen, Ke-Min No. 369 Jiasong Zhong Road, Huaxin, Qingpu Shanghai 201708 CHINA
Re: K123126
Trade/Device Names: MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Nature: MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Blue; MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Nature: MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Blue
Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: April 26, 2014 Received: May 5, 2014
Dear Dr. Jen, Ke-Min:
This letter corrects our substantially equivalent letter of June 4, 2014.
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.
6
Page 2 - Dr. Jen, Ke-Min
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.
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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | See PRA Statement below |
| 510(k) Number (if known) | K123126 |
|---|---|
| Device Name | MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Nature |
| MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Blue | |
| MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Nature | |
| MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Blue |
| Indications for Use (Describe) | MOTEX Polyisoprene Powder-Free Sterile Surgical Gloves are powder-free surgeon's glove 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 | Elizabeth F. Claverie |
|---|---|
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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