G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE

K121335 · Hutchinson Sante S.N.C. · KGO · Sep 13, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121335
• Device Name: G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE
• Applicant: Hutchinson Sante S.N.C.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Sep 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

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.

Device Story

G-Derm™ is a disposable, sterile, powder-free surgical glove composed of synthetic copolymers (SEBS and SEPSEP). The glove features a polyurethane-based inner coating to facilitate donning. It is intended for use by operating room personnel as a physical barrier to protect surgical wounds from contamination. The device is provided sterile via gamma irradiation. It is used in surgical environments to maintain aseptic conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including physical property testing (ASTM D3577), freedom from holes (ASTM D5151), powder content (ASTM D6124), and biocompatibility testing (ISO 10993-5, -10, -11).

Technological Characteristics

Materials: Styrene-ethylene/butylene-styrene (SEBS) and styrene-ethylene/propylene-styrene-ethylene/propylene (SEPSEP) synthetic copolymers. Inner coating: Polyurethane. Sterilization: Gamma irradiation (SAL 10-6). Standards: ASTM D3577, ASTM D5151, ASTM D6124, ISO 11737, ISO 10993. Form factor: Surgical glove, 280 mm length, 0.21 mm thickness.

Indications for Use

Indicated for operating room personnel to protect surgical wounds from contamination. Disposable, sterile, powder-free device.

Regulatory Classification

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.

Predicate Devices

• Elastyfree by ECI Medical Technologies Inc (K020918)
• Safeskin Tactylon PF powder-free surgical gloves (K994081)
• Tactylon by Tactyl Technologies (K955419)

Submission Summary (Full Text)

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K121335

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<br>F-60140 Liancourt<br>FRANCE |
| Phone : | [phone] |
| Fax : | [phone] |

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 | Safeskin<br>Tactylon | Tactylon |
|-------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------|
| Regulation No. | 21 CFR<br>878.4460 | 21 CFR<br>878.4460 | 21 CFR<br>878.4460 | 21 CFR<br>878.4460 |
| Device Class | Class I | Class I | Class I | Class I |
| Technology | Solvent borne<br>material | Solvent borne<br>material | Solvent borne<br>material | Solvent borne<br>material |
| Patient<br>contacting<br>physical barrier<br>material | Styrenic<br>thermoplastic<br>elastomers | Styrenic<br>thermoplastic<br>elastomers | Styrenic<br>thermoplastic<br>elastomer | Styrenic<br>thermoplastic<br>elastomer |
| User contacting<br>physical barrier<br>material | Styrenic<br>thermoplastic<br>elastomers with<br>a polyurethane<br>coating | Styrenic<br>thermoplastic<br>elastomers with<br>a polyurethane<br>coating | Styrenic<br>thermoplastic<br>elastomers with<br>a polymer<br>coating | Styrenic<br>thermoplastic<br>elastomer |
| Standards met | ASTM D3577<br>ASTM D5151<br>ASTM D6124 | ASTM D3577<br>ASTM D5151<br>ASTM D6124 | ASTM D3577<br>ASTM D5151<br>ASTM D6124 | ASTM D3577<br>ASTM D5151<br>ASTM D6124 |
| Sterilization | Sterile (SAL 10-6). Gamma<br>irradiation | Sterile (SAL 10-6). Gamma<br>irradiation | Sterile. Gamma<br>irradiation | Sterile. (method<br>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, |

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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 [phone] or [phone] 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:_

Page 1 of 1

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