(196 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization of latex surgical gloves, with no mention of AI or ML.
No
The device, a surgical glove, is intended to protect a surgical wound from contamination, which is a prophylactic or protective function, not a therapeutic one that treats or cures a disease or condition.
No
The device is a surgical glove, intended to protect a surgical wound from contamination, not to diagnose a condition.
No
The device description clearly states it is a physical product made of natural rubber latex (gloves) and describes physical characteristics and testing, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "to be worn by operating room personnel to protect a surgical wound from contamination." 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 (natural rubber latex), form (gloves), and sterilization method. 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 samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Reagents or assay components
The device described is a medical device used for protection and barrier purposes in a surgical setting.
N/A
Intended Use / Indications for Use
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes (comma separated list FDA assigned to the subject device)
KGO
Device Description
The proposed device, Latex Surgeon's Gloves (Powdered and Powder Free) is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device is made of natural rubber latex. per standard ASTM D3577-0961, the rubber surgical gloves classification is:
"Type 1 - gloves compounded primarily from natural rubber latex".
The proposed device include Powder Free Latex Surgeon's Gloves, and variations of different size. All variations share the same colour, creamy white.
The proposed device is provided radiation sterilized to achieve the Sterility Assurance Level (SAL) of 10% and place in a sterility maintenance package to ensure a shelf life of 3 years.
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)
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ASTM D3577-0981, Standard Specification for Rubber Surgical Gloves.
ASTM D 5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves.
ASTM D5712-10. Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
ASTM D6499-07, Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products.
ASTM F1929-98 (2004). Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
ISO11137-2: 2006. Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose.
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
Section III 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
K130301 The assigned 510(k) Number:
-
- Date of Submission: January 11, 2013
-
- Sponsor
AUG 2 2 2013
Elimedical Devices(Fujian) Inc. E06, Wuping Industrial Park, Wuping, Fujian 364300, China
Contact Person: Mr. He Yangui Position: Manager Tel: +86-10-67617923 Fax: +86-10-67617393 Email: KEVIN@ELIMEDICAL.COM
-
- Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
- Proposed Device Identification 4.
Trade Name: 1). REDLEAF, Elimedical, and 2) Multiple or Customers' Trade Name Device Name: Latex Surgeon's Gloves (Powdered and Powder Free) Common Name: Surgical Gloves
Classification: I Product Code: Surgeon's Glove - 79KGO Classification Name: surgeon's gloves Regulation Number: 21 CFR 878.4460 Review Panel: General & Plastic Surgery
III - 1
1
Intended Use Statement:
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
-
- Predicate Device Identification
510(k) Number: K063757
- Predicate Device Identification
Product Name: Motex Powder-Free Surgical Gloves & Powdered Latex Surgical Gloves Manufacturer: SHANGHAI MOTEX HEALTHCARE CO., L TD.
-
- Device Description
The proposed device, Latex Surgeon's Gloves (Powdered and Powder Free) is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination.
- Device Description
The proposed device is made of natural rubber latex. per standard ASTM D3577-0961, the rubber surgical gloves classification is:
"Type 1 - gloves compounded primarily from natural rubber latex".
The proposed device include Powder Free Latex Surgeon's Gloves, and variations of different size. All variations share the same colour, creamy white.
The proposed device is provided radiation sterilized to achieve the Sterility Assurance Level (SAL) of 10% and place in a sterility maintenance package to ensure a shelf life of 3 years.
-
- Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
ASTM D3577-0981, Standard Specification for Rubber Surgical Gloves.
ASTM D 5151-06 (Reapproved 2011), Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (Reaffirmation 2011), Standard Test Method for Residual Powder on Medical Gloves.
ASTM D5712-10. Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
ASTM D6499-07, Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products.
ASTM F1929-98 (2004). Standard Test Method for Detecting Seal Leaks in Porous Medical III-2
2
Packaging by Dye Penetration.
ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials.
ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
ISO11137-2: 2006. Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose.
-
- Substantially Equivalent Comparison Conclusion
| ITEM | Proposed Device | Predicate Device (K063757) |
|---|---|---|
| Product Code | KGO | Same |
| Regulation No. | 21 CFR 878.4460 | Same |
| Class | 1 | Same |
| Intended Use | A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. | Similar |
| Powdered or Powered free | Powdered, and Powered free | Same |
| Classification per ASTM D3577 | Type 1 - gloves compounded primarily from natural rubber latex | Same |
| Dimensions | Size 6, 6 $^{1}!/{2}$ , 7, 7 $^{1}!/{2}$ , 8, 8 $^{1}!/_{2}$ , 9 | |
| Dimensions comply with ASTM D3577 | Same | |
| Physical Properties | Comply with ASTM D3577 | Same |
| Freedom from Holes | Comply with ASTM D3577 and ASTM D5151 | Same |
| Powder Content | Comply with ASTM D3577 and ASTM D6124 | Same |
| Protein Content | Comply with ASTM D3577, ASTM D5712 and ASTM D6499 | Same |
| Biocompatibility | Comply with ISO 10993-10 | Same |
| Sterilization | Radiation | |
| SAL: 10 $^{-6}$ | Same | |
| Label and Labeling | Meet FDA's Requirements | Same |
Table III-1 Substantially Equivalent Comparison
Difference in intended use between the proposed and predicate device is discussed in the 510(k) submission documents, it is concluded that the difference will not affectiveness and safety of the proposed device.
The proposed device, Latex Surgeon's Gloves (Powdered and Powder Free), is determined to be Substantially Equivalent (SE) to the predicate device, Motex Powder-Free Surgical Gloves & Powdered Latex Surgical Gloves (K063757), in respect of safety and effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2013
EliMedical Devices (Fujian) Incorporated C/O Ms. Diana Hong General Manager Mid-Link Consulting Company, Limited P.O. Box 237-023, Shanghai, China 200237
Re: K130301
Trade/Device Name: Latex Surgeon's Gloves (Powdered and Powder Free) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: KGO Product Code: I Dated: July 5, 2013 Received: August 2, 2013
Dear Ms. Hong:
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.
4
Page 2 - Ms. Hong
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/Resourcesfor You/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/6 description: The image shows the name "Mary S. Runner - S" in a bold, sans-serif font. The letters are large and spaced closely together. The word "Runner" is partially obscured by a graphic element that appears to be a stylized logo or design.
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section II Indications for Use
K130301 510(k) Number:
Device Name: Latex Surgeon's Gloves (Powdered and Powder Free)
Indications for Use:
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
OPRESCRIPTION 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 ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sreekanth-Gutala-S
2013.08.22 11:47:44 -04'00'
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _13030