(133 days)
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.
The G-Derm™ Powder Free Surgical Glove is made of a blend of styrene-ethylene/butylene-styrene (SEBS) and styrene-ethylene/propylene-styrene-ethylene/propylene (SEPSEP) synthetic copolymers. It is coated with a polyurethane based coating on the inner side to facilitate donning.
The provided text describes a 510(k) submission for the Hutchinson Santé G-Derm™ Surgical Glove, a Class I medical device. The submission focuses on demonstrating substantial equivalence to predicate devices through performance data and adherence to recognized standards, rather than an AI-driven diagnostic or prescriptive device requiring complex clinical studies. As such, many of the requested categories (like MRMC studies, number of experts for ground truth, adjudication methods, training set information) are not applicable to this type of device submission.
Here's a breakdown based on the provided document:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Thickness | Meets ASTM D3577 | 0.21 ± 0.02 mm |
| Length | Meets ASTM D3577 | 280 mm min. |
| Physical Properties | Meets ASTM D3577, Type 2 | Meets ASTM D3577, Type 2 |
| Powder Free | Meets ASTM D6124 (< 2 mg/glove) | Less than 2 mg per glove |
| Freedom from holes (AQL) | Meets ASTM D5151 (0.25) | AQL 0.25 |
| Sterility (SAL) | ISO 11737 (10-6) | SAL 10-6 |
| Biocompatibility: In Vitro Cytotoxicity | ISO 10993-5 (Passes) | Passes |
| Biocompatibility: Acute Systemic Toxicity in Mice | ISO 10993-11 (Passes) | Passes |
| Biocompatibility: Primary skin irritation in Rabbits | ISO 10993-10 (Passes) | Passes |
| Biocompatibility: Guinea Pig Maximization Sensitization | ISO 10993-10 (Passes) | Passes |
2. Sample size used for the test set and the data provenance
The document does not specify the precise sample sizes for each test conducted (e.g., how many gloves were tested for thickness, holes, etc.) or the data provenance beyond stating that the tests meet the listed ASTM and ISO standards. For device performance testing of physical characteristics and biocompatibility, these would typically be conducted by the manufacturer or accredited labs on representative samples as part of their quality control and R&D processes. The data would be prospective, generated specifically for the device under evaluation.
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 device and submission type. The "ground truth" for surgical gloves is established by objective measurements based on the specified ASTM and ISO standards, not expert consensus or interpretation of complex data.
4. Adjudication method for the test set
This is not applicable. Adjudication methods are typically used in clinical studies or studies involving subjective interpretation of data (e.g., radiology reads). For physical and chemical tests of a surgical glove, the results are quantitative and directly compared against the standard's limits.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The G-Derm™ Surgical Glove is a physical medical device, not an AI-driven one. No such study would be performed for this product.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a surgical glove, not an algorithm.
7. The type of ground truth used
The ground truth is established by the specified ASTM International (ASTM) and International Organization for Standardization (ISO) standards. These standards define the acceptable physical, chemical, and biological properties for surgical gloves. The device performance is measured objectively against the quantitative and qualitative requirements outlined in these standards.
8. The sample size for the training set
This is not applicable. As a physical medical device (surgical glove), there is no 'training set' in the context of machine learning or AI.
9. How the ground truth for the training set was established
This is not applicable. There is no training set for this device.
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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 PaturelF-60140 LiancourtFRANCE |
| 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
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ﺒﻠ
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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 | SafeskinTactylon | Tactylon | |
|---|---|---|---|---|
| Regulation No. | 21 CFR878.4460 | 21 CFR878.4460 | 21 CFR878.4460 | 21 CFR878.4460 |
| Device Class | Class I | Class I | Class I | Class I |
| Technology | Solvent bornematerial | Solvent bornematerial | Solvent bornematerial | Solvent bornematerial |
| Patientcontactingphysical barriermaterial | Styrenicthermoplasticelastomers | Styrenicthermoplasticelastomers | Styrenicthermoplasticelastomer | Styrenicthermoplasticelastomer |
| User contactingphysical barriermaterial | Styrenicthermoplasticelastomers witha polyurethanecoating | Styrenicthermoplasticelastomers witha polyurethanecoating | Styrenicthermoplasticelastomers witha polymercoating | Styrenicthermoplasticelastomer |
| Standards met | ASTM D3577ASTM D5151ASTM D6124 | ASTM D3577ASTM D5151ASTM D6124 | ASTM D3577ASTM D5151ASTM D6124 | ASTM D3577ASTM D5151ASTM D6124 |
| Sterilization | Sterile (SAL 10-6). Gammairradiation | Sterile (SAL 10-6). Gammairradiation | Sterile. Gammairradiation | Sterile. (methodunknown) |
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, |
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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.
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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.
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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
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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:_
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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).