(220 days)
Not Found
No
The 510(k) summary describes surgical gloves, which are physical barrier devices. There is no mention of software, algorithms, or any technology that would incorporate AI or ML. The description focuses on material properties and compliance with standards.
No.
The device acts as a barrier against contaminants, not to treat or diagnose a disease or condition.
No
The device is a surgical glove, intended to provide a barrier against infectious materials. Its described function does not involve analysis of data to identify a medical condition or risk factor.
No
The device is a physical product (surgical gloves) made of natural rubber latex, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the gloves are "intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants." This describes a physical barrier device used for protection, 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 material (natural rubber latex), form (powdered or powder-free), and physical characteristics of the gloves. There is no mention of reagents, calibrators, controls, or any components typically associated with IVD devices.
- Performance Studies: The document explicitly states "Clinical Data: Not applicable." IVD devices typically require performance studies demonstrating their analytical and clinical validity.
- Lack of IVD-related terms: There are no mentions of terms like "in vitro," "specimen," "assay," "analyte," "diagnosis," "monitoring," or "treatment" in the context of analyzing biological samples.
In summary, the Motex Surgical Gloves are a Class II medical device intended for barrier protection during surgical procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Motex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Motex Powdered Latex Surgical Gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
Motex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder).
Motex Powdered Latex Surgical Gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical settings
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)
Not applicable.
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
JUL 27 2007
SHANGHAI MOTEX HEATHCARE CO., LTD.
No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: 86-21-5979 9888 Fax: 86-21-5979 9728 E-mail: motex@public 1.sta.net.cn
દર્ 510(k) SUMMARY "
The assigned 510(k) number is : __ K063757
Submitter's Name: SHANGHAI MOTEX HEALTHCARE CO., LTD. No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China
Date summary prepared: Device Name:
November 26, 2006
- Classification name: Surgeon's Gloves
- . Classification number: KGO, Class I
- Regulation Number: 878.4460
- . Proprietary name: Motex Powder-Free Surgical Gloves & Powdered Latex Surgical Gloves
- . Predicate Device: K050071. MEDISPO powdered surgeon's gloves and MEDISPO-PF powder-free surgeon's gloves
. Official Correspondent: Dr. Jen. Ke-Min
E-mail: ceirs.jen@msa.hint.net (Tel) 886-3-5208829; (Fax) 886-3-5209783 Address: No.58, Fu Chiun Street, Hsin Chu City, 30067, Taiwan, ROC
● Intended Use:
Motex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
1
SHANGHAI MOTEX HEATHCARE CO., LTD.
No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Fax: 86-21-5979 9728 Telephone: 86-21-5979 9888 E-mail: motex@public1.sta.net.cn
Motex Powdered Latex Surgical Gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants..
Technological Characteristics: ●
The Motex Powder-Free Surgical Gloves & Powdered Latex Surgical Gloves characteristics are summarized below compared to ASTM and ISO standards to the predicate device:
| Characteristic | Standard |
|---|---|
| Dimensions | meets ASTM D 3577-06, |
| Physical Properties | meets ASTM D 3577-06, |
| Freedom from Holes | meets ASTM D 3577-06, |
| Biocompatibility | meets ISO10993-5/-10 |
| Sterilization Validation | meets ISO11137 |
- . Clinical Data:
Not applicable.
● Conclusions:
The Motex Powder-Free Surgical Gloves & Powdered Latex Surgical Gloves and predicate devices also meet the technological characteristics of ASTM D 3577-06, ISO10993-5/-10, and ISO11137 standards. Besides, for Powder-Free SURGICAL GLOVES contain no more than 2mg powder and no more than 50ug/dm2 extractable protein, and for Powdered I.atex SURGICAL GLOVES contuin no more than 120mg powder and no more than 120ug/dm2 extractable protein claim.
Thus the new devices are substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 7 2007
Shanghai Motex Healthcare Company Limited C/O Dr. Jen Ke-Min Official Correspondent ROC Chinese-European Industrial No. 58, Fu Chiun Street Hsin Chu City, Taiwan 30067 CHINA
Re: K063757
Trade/Device Name: Motex Powder-Free Surgical Gloves and Powdered Latex Surgical Gloves Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: June 15, 2007
Received: June 29, 2007
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 ffor 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), please contact the Office of Compliance 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 Division of Small Manufacturers, 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,
Sutterf. Mckano MD
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
4
Indications for Use
510 (K) Number ( If Known ):
Device Name: Motex Powder-Free Surgical Gloves and Powdered Latex Surgical Gloves
Indications for Use:
Motex Powder-Free Surgical Gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Motex Powdered Latex Surgical Gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
Prescription Use
AND/OR
Over-The-Counter Use $\sqrt{}$
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
P.4
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Mision Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
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