Gammex PI Hybrid Surgical Gloves

K151694 · Ansell Healthcare Products, LLC · KGO · Mar 9, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K151694
• Device Name: Gammex PI Hybrid Surgical Gloves
• Applicant: Ansell Healthcare Products, LLC
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Mar 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

Gammex PI Hybrid Surgical Glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Single-use, sterile, powder-free surgical glove; composed of synthetic rubber blend (polyisoprene and neoprene) with polyurethane inner coating for donning. Used by operating room personnel to provide a physical barrier protecting surgical wounds from contamination. Device is hand-specific with a beaded cuff. Performance verified through bench testing against ASTM standards for dimensions, physical properties, freedom from holes, and biocompatibility.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including dimensions, physical properties (tensile strength/elongation), freedom from holes (AQL 1.5), powder residue levels, and biocompatibility (ISO 10993-10 irritation and sensitization studies).

Technological Characteristics

Synthetic rubber blend (polyisoprene and neoprene); polyurethane inner coating. Dimensions/physical properties per ASTM D3577-09. Freedom from holes per ASTM D5151-06. Powder-free per ASTM D6124-06. Sterilization via radiation (10^-6 SAL) per ANSI/AAMI/ISO 11137-1:2006. Biocompatibility per ISO 10993-10:2010.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. No specific patient population or contraindications defined.

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

• Derma Prene PI or Isotouch Green sterile Powder-Free Synthetic Polyisoprene Surgical Gloves (K071746)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 9, 2016

Ansell Healthcare Products, LLC Vasudev Dobariya Regulatory Specialist 111 Wood Avenue South, Suite 210 Iselin. New Jersev 08830

Re: K151694

Trade/Device Name: Gammex PI Hybrid Surgical Glove Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: February 3, 2016 Received: February 8. 2016

Dear Vasudev Dobariya:

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.

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

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Teiashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K151694

Device Name Gammex PI Hybrid Surgical Glove

Indications for Use (Describe)

Gammex PI Hybrid Surgical Glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.

Type of Use (Select one or both, as applicable)

- Prescription Use (Part 21 CFR 801 Subpart D)

> Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary

The assigned 510(k) number is: K151694

### Submitter

Ansell Healthcare Products LLC. 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 USA

# Contact Person:

Vasudev Dobariya Regulatory Affairs Specialist Phone: [phone] [e-mail]

#### Date Prepared

March 7, 2016

# Name of Device

| Trade Names: | Gammex PI Hybrid Surgical Glove (also marketed as Encore PI Hybrid |
|----------------------------|--------------------------------------------------------------------|
| | Surgical Glove) |
| Common Name: | Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Classification Regulation: | 21 CFR 878.4460 |
| Device Class: | I |
| Product Code: | KGO |
| Classification Panel: | General and Plastic Surgery |

#### Legally Marketed Predicate Device

K071746 - Derma Prene Pl or Isotouch Green sterile Powder-Free Synthetic Polyisoprene Surgical Gloves

# Device Description

The subject device is single-use disposable powder-free surgical glove that is supplied sterile and made of synthetic rubber blend of polyisoprene and neoprene.

# Indications for Use

Gammex PI Hybrid Surgical Glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.

#### Technological Characteristics

Gammex PI Hybrid Surgical Glove have the following technological characteristics as compared to ASTM or equivalent standards:

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| Technological | Standard/Test/FDA Guidance | Result Summary |
|-----------------------------------------|--------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Characteristics | | |
| Dimensions | ASTM D3577-09 | Meets ASTM D3577-09<br>requirements for length, width<br>and thickness |
| --Length | Minimum 265mm | Average 305mm |
| --Palm Width(size) | (mm) | Average value in mm |
| 5.5 | 70±6 | 73 |
| 6.0 | 76±6 | 80 |
| 6.5 | 83±6 | 86 |
| 7.0 | 89±6 | 91 |
| 7.5 | 95±6 | 97 |
| 8.0 | 102±6 | 103 |
| 8.5 | 108±6 | 110 |
| 9.0 | 114±6 | 117 |
| --Thickness | (mm) | Average value in mm |
| Finger | Minimum 0.10 | 0.22 |
| Palm | Minimum 0.10 | 0.20 |
| Cuff | Minimum 0.10 | 0.17 |
| Physical Properties | ASTM D3577-09 | Meets ASTM D3577-09<br>requirements for tensile strength<br>and elongation at break before<br>and after accelerated aging |
| Freedom from holes | ASTM D3577-09<br>ASTM D5151-06 | Meets ASTM D3577-09 and ASTM<br>D5151-06 requirements of AQL<br>1.5 |
| Powder-Free | ASTM D3577-09<br>ASTM D6124-06 | Meets Applicable requirement for<br>Powder Free; ≤ 2 mg per glove |
| Sterility | ANSI/AAMI/ISO 11137-1:2006 | Meets ANSI/AAMI/ISO 11137-<br>1:2006 requirement of 10-6 SAL |
| Biocompatibility: | | |
| ISO Skin Irritation Study | ISO 10993-10:2010 | Under the conditions of the study,<br>not an irritant |
| ISO Maximization<br>Sensitization Study | ISO 10993-10:2010 | Under the conditions of the study,<br>not a sensitizer |

# Substantial Equivalence

| | | | Substantial Equivalence Comparison Table | |
|--|--|--|------------------------------------------|--|
|--|--|--|------------------------------------------|--|

| | Predicate Device | Subject Device | Substantial<br>Equivalence |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Trade Name | Derma Prene PI or Isotouch<br>Green Sterile Powder-Free<br>Polyisoprene Surgical Gloves | Gammex PI Hybrid Surgical<br>Glove | Not<br>applicable |
| 510(k) Number | K071746 | K151694 | Not<br>applicable |
| Submitter | Ansell Healthcare Products LLC | Ansell Healthcare Products LLC | Yes |
| | Predicate Device | Subject Device | Substantial<br>Equivalence |
| Product Code | KGO | KGO | Yes |
| Regulation<br>Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Yes |
| Regulation<br>Name | Surgeon's glove | Surgeon's glove | Yes |
| Indications for<br>Use | These gloves are intended to<br>be worn by operating room<br>personnel to protect a<br>surgical wound from<br>contamination. | This glove is intended to be<br>worn by operating room<br>personnel to protect a surgical<br>wound from contamination. | Yes |
| Prescription<br>or Over-The<br>Counter-Use | Over-The-Counter-Use | Over-The-Counter-Use | Yes |
| Materials | Synthetic polyisoprene rubber | Synthetic rubber blend of<br>polyisoprene and neoprene | Yes with<br>difference |
| Coating | Polyurethane polymer inner<br>coating to aid donning | Polyurethane polymer inner<br>coating to aid donning | Yes |
| Design | Single use | Single use | Yes |
| | Sterile | Sterile | Yes |
| | Powder-free | Powder-free | Yes |
| | Hand specific | Hand specific | Yes |
| | Beaded cuff | Beaded cuff | Yes |
| Color | Green | White | Yes with<br>difference |
| Sterilization<br>method | Radiation | Radiation | Yes |
| Sterility<br>Assurance<br>Level (SAL) | 10-6 SAL | 10-6 SAL | Yes |
| Shelf Life | 3 years | 3 years | Yes |
| Dimensions<br>and physical<br>properties | Meets ASTM D3577-09<br>requirements | Meets ASTM D3577-09<br>requirements | Yes |
| Freedom<br>from holes | Meets ASTM D3577-09<br>requirements of AQL 1.5 | Meets ASTM D3577-09<br>requirements of AQL 1.5 | Yes |
| Powder-Free | Meets Applicable Definition for<br>Powder Free; ≤ 2 mg per glove | Meets Applicable Definition for<br>Powder Free; ≤ 2 mg per glove | Yes |
| Biocompatibility | "Under the conditions of the<br>study, not an irritant" and<br>"Under the conditions of the<br>study, not a sensitizer" | "Under the conditions of the<br>study, not an irritant" and<br>"Under the conditions of the<br>study, not a sensitizer" | Yes |

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The subject device is manufactured from synthetic rubber blend of polyisoprene and neoprene with polyurethane polymer inner coating to aid donning. The predicate device is manufactured from synthetic

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polyisoprene rubber with polymer inner coating to aid donning. Though the materials of construction differ, the subject device's materials are functionally equivalent to those of the cited predicate.

The subject device meets the applicable requirements for surgeon's gloves with regard to dimensions and sizes, physical properties, freedom from holes, powder residues, and protein content as found in the following standards: ASTM D3577-09, ASTM D5151-06 and ASTM D6124-06. The subject device passes biological reactivity testing for dermal sensitization and irritation, in accord with the ISO 10993 series of standards.

# Performance Data

A clinical study was not conducted on the subject or predicate devices.

# Substantial Equivalence Statement

The Gammex Pl Hybrid Surgical Glove is substantially equivalent to the predicate device with respect to design, technological characteristics, intended use and conformance to standard requirements.

# Conclusion:

The Gammex Pl Hybrid Surgical Glove is substantially equivalent to the Derma Prene Pl or Isotouch Green sterile Powder-Free Synthetic Polyisoprene Surgical Gloves. Based on the performed nonclinical tests, the subject device performs as safely and as effectively as the legally marketed predicate device, Derma Prene Pl or Isotouch Green sterile Powder-Free Synthetic Polyisoprene Surgical Gloves, previously cleared under K071746, Class I (21 CFR 878.4460, Product code KGO).