(133 days)
Not Found
No
The device description and performance studies focus on the material properties and physical characteristics of a surgical glove, with no mention of AI or ML technology.
No
Therapeutic devices are used for treatment or prevention of disease. This device is a surgical glove intended to protect a surgical wound from contamination, which is a protective barrier function, not a therapeutic one.
No
The device is a surgical glove intended to protect a surgical wound from contamination, not to diagnose a condition or disease.
No
The device is a physical surgical glove made of synthetic copolymers, not software.
Based on the provided information, 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 samples taken from the human body.
- Device Description: The description details the materials and physical characteristics of a glove. It does not describe 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 biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
Therefore, the G-Derm™ Surgical Glove is a medical device intended for protection, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The G-Derm™ Surgical Glove is a disposable sterile powder-free medical device made of styrene-ethylene/butylene-styrene (SEBS) and styrene-ethylene/propylene-styreneethylene/propylene (SEPSEP) synthetic copolymers that is 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 G-Derm™ Powder Free Surgical Glove is made of a blend of styrene-(SEBS) and styrene-ethylene/propylene-styreneethylene/butylene-styrene
ethylene/propylene (SEPSEP) synthetic copolymers. It is coated with a polyurethane based coating on the inner side to facilitate donning.
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)
The G-Derm™ Surgical Glove possesses the following technological characteristics:
Thickness: 0.21 ±0.02 mm, Meets ASTM D3577 Type 2
Length: 280 mm min., Meets ASTM D3577 Type 2
Physical Properties, Meets ASTM D3577, Type 2
Powder Free: less than 2 mg per glove, Meets ASTM D6124
Freedom from holes: AQL 0.25, Meets ASTM D5151
Sterility: SAL 10-6, ISO 11737
Biocompatibility: ISO 10993-1
In Vitro Cytotoxicity: Passes, ISO 10993-5
Acute Systemic Toxicity in Mice: Passes, ISO 10993-11
Primary skin irritation in Rabbits: Passes, ISO 10993-10
Guinea Pig Maximization Sensitization: Passes, ISO 10993-10
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
August 28, 2012 Traditional 510(k)
- Hutchinson Santé G-Derm™ Surgical Glove
- న. 510(k) SUMMARY [per 21 CFR 807.92]
5.1 Submitter Information
| Name : | Hutchinson Santé S.N.C. |
|---|---|
| Address : | Rue Marret et Paturel |
| F-60140 Liancourt | |
| FRANCE | |
| Phone : | +33 (0) 3 44 73 87 00 |
| Fax : | +33 (0) 3 44 73 87 09 |
Contact Name: Dr Raffi Krikorian, Ph.D
Date of summary: August 28, 2012
5.2 Device Identification
G-Derm™ Powder Free Surgical Glove made of styrene-Trade name: ethylene/butylene-styrene (SEBS) and styreneethylene/propylene-styrene-ethylene/propylene (SEPSEP) synthetic copolymers
Common name: Surgical glove Classification name: Surgeon's glove
Product Code: KGO 21 CFR 878.4460 Regulation number: Class I (general controls) Device Class:
5.3 Identification of Predicate Devices
- . Elastyfree by ECI Medical Technologies Inc (K020918)
- Safeskin Tactylon PF powder-free surgical gloves (K994081) .
- Tactylon by Tactyl Technologies (K955419) .
5.4 Device Description
The G-Derm™ Powder Free Surgical Glove is made of a blend of styrene-(SEBS) and styrene-ethylene/propylene-styreneethylene/butylene-styrene
SEP 1 3 2012
ﺔ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟ
ﺒﻠ
1
ethylene/propylene (SEPSEP) synthetic copolymers. It is coated with a polyurethane based coating on the inner side to facilitate donning.
5.5 Indications for Use
The G-Derm™ Surgical Glove is a disposable sterile powder-free medical device styrene-ethylene/butylene-styrene (SEBS) made of styreneethylene/propylene-styrene-ethylene/propylene (SEPSEP) synthetic copolymers that is intended to be worn by operating room personnel to protect a surgical wound from contamination.
| | G-DermTM | Elastyfree | Safeskin
Tactylon | Tactylon |
|-------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------|
| Regulation No. | 21 CFR
878.4460 | 21 CFR
878.4460 | 21 CFR
878.4460 | 21 CFR
878.4460 |
| Device Class | Class I | Class I | Class I | Class I |
| Technology | Solvent borne
material | Solvent borne
material | Solvent borne
material | Solvent borne
material |
| Patient
contacting
physical barrier
material | Styrenic
thermoplastic
elastomers | Styrenic
thermoplastic
elastomers | Styrenic
thermoplastic
elastomer | Styrenic
thermoplastic
elastomer |
| User contacting
physical barrier
material | Styrenic
thermoplastic
elastomers with
a polyurethane
coating | Styrenic
thermoplastic
elastomers with
a polyurethane
coating | Styrenic
thermoplastic
elastomers with
a polymer
coating | Styrenic
thermoplastic
elastomer |
| Standards met | ASTM D3577
ASTM D5151
ASTM D6124 | ASTM D3577
ASTM D5151
ASTM D6124 | ASTM D3577
ASTM D5151
ASTM D6124 | ASTM D3577
ASTM D5151
ASTM D6124 |
| Sterilization | Sterile (SAL 10-6). Gamma
irradiation | Sterile (SAL 10-6). Gamma
irradiation | Sterile. Gamma
irradiation | Sterile. (method
unknown) |
5.6 Comparison to Predicate Devices
5.7 Performance Data
The G-Derm™ Surgical Glove possesses the following technological characteristics:
| Characteristics | Standard |
|---|---|
| Thickness: 0.21 ±0.02 mm | Meets ASTM D3577 |
| Length: 280 mm min. | Meets ASTM D3577 |
| Physical Properties | Meets ASTM D3577, |
2
Hutchinson Santé G-Derm™ Surgical Glove
August 28, 2012 Traditional 510(k)
| Type 2 | |
|---|---|
| Powder Free: less than 2 mg per glove | Meets ASTM D6124 |
| Freedom from holes: AQL 0.25 | Meets ASTM D5151 |
| Sterility: SAL 10-6 | ISO 11737 |
| Biocompatibility: | ISO 10993-1 |
| In Vitro Cytotoxicity: Passes | ISO 10993-5 |
| Acute Systemic Toxicity in Mice: Passes | ISO 10993-11 |
| Primary skin irritation in Rabbits: Passes | ISO 10993-10 |
| Guinea Pig Maximization Sensitization: Passes | ISO 10993-10 |
5.8 Clinical Data
Clinical data is not needed for medical glove 510(k) submissions.
It can be concluded that the G-Derm™ Surgical Glove will perform according to the performance standards referenced above, FDA requirements and the labeling claims for this product. Consequently, this device is substantially equivalent to currently marketed devices.
3
Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 13 2012
Hutchinson Santé S.N.C. Dr. Raffi Krikorian Vice President Science & Regulatory Rue Marret et Paturel Liancourt, France F-60140
Re: K121335
Trade/Device Name: G-Derm™ Powder Free Surgical Glove made of Styrene-Ethylene/Butylene-Styrene (SEBS) and Styrene-Ethylene/ Propylene-Styrene-Ethylene/Propylene (SEPSEP) Synthetic Copolymers
Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: August 28, 2012 Received: August 29, 2012
Dear Dr. Krikorian:
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.
4
Page 2- Dr. Krikorian
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.
For
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Hutchinson Santé G-Derm™ Surgical Glove
August 28, 2012 Traditional 510(k)
INDICATIONS FOR USE STATEMENT 4.
510(k) Number (if known): K121335
Device Name: G-Derm™ Powder Free Surgical Glove made of styrene-ethylene/butylenestyrene (SEBS) and styrene-ethylene/propylene-styreneethylene/propylene (SEPSEP) synthetic copolymers
Indications for Use:
The G-Derm™ Surgical Glove is a disposable sterile powder-free medical device made of styrene-ethylene/butylene-styrene (SEBS) and styrene-ethylene/propylene-styreneethylene/propylene (SEPSEP) synthetic copolymers that is intended to be worn by operating room personnel to protect a surgical wound from contamination.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (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)
Rovil Gangulic
(Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:_
Page 1 of 1
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