(260 days)
Not Found
No
The summary describes a surgical glove and does not mention any AI or ML capabilities.
No.
The device is a surgical glove intended for protection against contamination, not for treating a disease or condition.
No
Explanation: The device is a surgical glove, intended to protect a surgical wound from contamination, not to diagnose a condition.
No
The device is a physical surgical glove made of synthetic rubber, 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 protect a surgical wound from contamination by being worn by operating room personnel. This is a barrier function for infection control, not a diagnostic test performed on a sample from the human body.
- Device Description: The device is a surgical glove, which is a physical barrier. It does not involve reagents, instruments, or procedures for examining specimens from the body to provide diagnostic information.
- Lack of IVD Characteristics: The description 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 the body
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the Gammex PI Hybrid Surgical Glove falls under the category of a medical device used for protection and infection control, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Gammex PI Hybrid Surgical Glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.
Product codes
KGO
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.
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
A clinical study was not conducted on the subject or predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, conveying the department's authority and purpose.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
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: 732-345-5317 Vasudev.dobariya@ansell.com
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:
4
| Technological | Standard/Test/FDA Guidance | Result Summary |
|---|---|---|
| Characteristics | ||
| Dimensions | ASTM D3577-09 | Meets ASTM D3577-09 |
| requirements for length, width | ||
| 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 |
| requirements for tensile strength | ||
| and elongation at break before | ||
| and after accelerated aging | ||
| Freedom from holes | ASTM D3577-09 | |
| ASTM D5151-06 | Meets ASTM D3577-09 and ASTM | |
| D5151-06 requirements of AQL | ||
| 1.5 | ||
| Powder-Free | ASTM D3577-09 | |
| ASTM D6124-06 | Meets Applicable requirement for | |
| Powder Free; ≤ 2 mg per glove | ||
| Sterility | ANSI/AAMI/ISO 11137-1:2006 | Meets ANSI/AAMI/ISO 11137- |
| 1:2006 requirement of 10-6 SAL | ||
| Biocompatibility: | ||
| ISO Skin Irritation Study | ISO 10993-10:2010 | Under the conditions of the study, |
| not an irritant | ||
| ISO Maximization | ||
| Sensitization Study | ISO 10993-10:2010 | Under the conditions of the study, |
| not a sensitizer |
Substantial Equivalence
| Substantial Equivalence Comparison Table | ||||
|---|---|---|---|---|
| -- | -- | -- | ------------------------------------------ | -- |
| | Predicate Device | Subject Device | Substantial
Equivalence |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Trade Name | Derma Prene PI or Isotouch
Green Sterile Powder-Free
Polyisoprene Surgical Gloves | Gammex PI Hybrid Surgical
Glove | Not
applicable |
| 510(k) Number | K071746 | K151694 | Not
applicable |
| Submitter | Ansell Healthcare Products LLC | Ansell Healthcare Products LLC | Yes |
| | Predicate Device | Subject Device | Substantial
Equivalence |
| Product Code | KGO | KGO | Yes |
| Regulation
Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Yes |
| Regulation
Name | Surgeon's glove | Surgeon's glove | Yes |
| Indications for
Use | These gloves are intended to
be worn by operating room
personnel to protect a
surgical wound from
contamination. | This glove is intended to be
worn by operating room
personnel to protect a surgical
wound from contamination. | Yes |
| Prescription
or Over-The
Counter-Use | Over-The-Counter-Use | Over-The-Counter-Use | Yes |
| Materials | Synthetic polyisoprene rubber | Synthetic rubber blend of
polyisoprene and neoprene | Yes with
difference |
| Coating | Polyurethane polymer inner
coating to aid donning | Polyurethane polymer inner
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
difference |
| Sterilization
method | Radiation | Radiation | Yes |
| Sterility
Assurance
Level (SAL) | 10-6 SAL | 10-6 SAL | Yes |
| Shelf Life | 3 years | 3 years | Yes |
| Dimensions
and physical
properties | Meets ASTM D3577-09
requirements | Meets ASTM D3577-09
requirements | Yes |
| Freedom
from holes | Meets ASTM D3577-09
requirements of AQL 1.5 | Meets ASTM D3577-09
requirements of AQL 1.5 | Yes |
| Powder-Free | Meets Applicable Definition for
Powder Free; ≤ 2 mg per glove | Meets Applicable Definition for
Powder Free; ≤ 2 mg per glove | Yes |
| Biocompatibility | "Under the conditions of the
study, not an irritant" and
"Under the conditions of the
study, not a sensitizer" | "Under the conditions of the
study, not an irritant" and
"Under the conditions of the
study, not a sensitizer" | Yes |
5
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
6
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).