(260 days)
Gammex PI Hybrid Surgical Glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.
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.
The provided document describes a 510(k) premarket notification for a surgical glove, the Gammex PI Hybrid Surgical Glove. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a new device meets specific acceptance criteria through a clinical study.
Therefore, many of the typical acceptance criteria and study details requested in the prompt related to AI/medical imaging device performance metrics (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this document. The document focuses on showing that the new glove is as safe and effective as a previously approved glove by meeting established material and performance standards for surgical gloves.
Here's an attempt to answer the questions based on the information provided, highlighting where it is not applicable or different for a surgical glove compared to an AI diagnostic device:
1. A table of acceptance criteria and the reported device performance
For a surgical glove, "acceptance criteria" are typically defined by recognized standards (like ASTM or ISO) for physical characteristics, integrity, and biocompatibility. The "reported device performance" indicates whether the device met these standards.
| Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (Result Summary) |
|---|---|
| Dimensions (ASTM D3577-09) | Meets ASTM D3577-09 requirements for length, width, and thickness |
| Length (Minimum 265mm) | Average 305mm |
| Palm Width (size 5.5: 70±6mm) | 73mm |
| Palm Width (size 6.0: 76±6mm) | 80mm |
| Palm Width (size 6.5: 83±6mm) | 86mm |
| Palm Width (size 7.0: 89±6mm) | 91mm |
| Palm Width (size 7.5: 95±6mm) | 97mm |
| Palm Width (size 8.0: 102±6mm) | 103mm |
| Palm Width (size 8.5: 108±6mm) | 110mm |
| Palm Width (size 9.0: 114±6mm) | 117mm |
| Thickness Finger (Minimum 0.10mm) | 0.22mm |
| Thickness Palm (Minimum 0.10mm) | 0.20mm |
| Thickness Cuff (Minimum 0.10mm) | 0.17mm |
| 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 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable in the context of the provided document, as it describes a clearance for a physical medical device (surgical glove) based on conformance to established standards for manufacturing and materials, not an AI or diagnostic device that relies on a "test set" of patient data. The tests are typically performed on samples from manufacturing lots.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The ground truth for a surgical glove is derived from standardized physical, chemical, and biological tests, not expert interpretation of images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used for expert consensus on diagnostic imaging or clinical outcomes, which is not relevant here.
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
An MRMC study is not applicable. This type of study is for evaluating observer performance with AI assistance for diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This question refers to the performance of an algorithm without human intervention, which is irrelevant for a surgical glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the surgical glove is based on objective measurements and assessments against established industry standards:
- Physical dimensions: Measured values (e.g., length, width, thickness).
- Physical properties (tensile strength, elongation): Measured values to ASTM D3577-09.
- Freedom from holes: Water leak test to ASTM D5151-06, meeting AQL 1.5.
- Powder-Free: Measurement of powder residue to ASTM D6124-06, meeting ≤ 2 mg per glove.
- Sterility: Sterilization validation to ANSI/AAMI/ISO 11137-1:2006, achieving 10-6 SAL.
- Biocompatibility: In-vivo animal studies for skin irritation and sensitization according to ISO 10993-10:2010.
8. The sample size for the training set
This is not applicable, as there is no "training set" for a surgical glove in the context of an AI/machine learning device. The manufacturing process is controlled and tested to meet specifications.
9. How the ground truth for the training set was established
This is not applicable. As there is no training set. The "ground truth" for the device's characteristics is established by widely accepted and published national and international standards (ASTM and ISO).
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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 (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
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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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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:
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| Technological | Standard/Test/FDA Guidance | Result Summary |
|---|---|---|
| Characteristics | ||
| Dimensions | ASTM D3577-09 | Meets ASTM D3577-09requirements for length, widthand 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 D3577-09requirements for tensile strengthand elongation at break beforeand after accelerated aging |
| Freedom from holes | ASTM D3577-09ASTM D5151-06 | Meets ASTM D3577-09 and ASTMD5151-06 requirements of AQL1.5 |
| Powder-Free | ASTM D3577-09ASTM D6124-06 | Meets Applicable requirement forPowder 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 MaximizationSensitization Study | ISO 10993-10:2010 | Under the conditions of the study,not a sensitizer |
Substantial Equivalence
| Substantial Equivalence Comparison Table | ||||
|---|---|---|---|---|
| -- | -- | -- | ------------------------------------------ | -- |
| Predicate Device | Subject Device | SubstantialEquivalence | |
|---|---|---|---|
| Trade Name | Derma Prene PI or IsotouchGreen Sterile Powder-FreePolyisoprene Surgical Gloves | Gammex PI Hybrid SurgicalGlove | Notapplicable |
| 510(k) Number | K071746 | K151694 | Notapplicable |
| Submitter | Ansell Healthcare Products LLC | Ansell Healthcare Products LLC | Yes |
| Predicate Device | Subject Device | SubstantialEquivalence | |
| Product Code | KGO | KGO | Yes |
| RegulationNumber | 21 CFR 878.4460 | 21 CFR 878.4460 | Yes |
| RegulationName | Surgeon's glove | Surgeon's glove | Yes |
| Indications forUse | These gloves are intended tobe worn by operating roompersonnel to protect asurgical wound fromcontamination. | This glove is intended to beworn by operating roompersonnel to protect a surgicalwound from contamination. | Yes |
| Prescriptionor Over-TheCounter-Use | Over-The-Counter-Use | Over-The-Counter-Use | Yes |
| Materials | Synthetic polyisoprene rubber | Synthetic rubber blend ofpolyisoprene and neoprene | Yes withdifference |
| Coating | Polyurethane polymer innercoating to aid donning | Polyurethane polymer innercoating 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 withdifference |
| Sterilizationmethod | Radiation | Radiation | Yes |
| SterilityAssuranceLevel (SAL) | 10-6 SAL | 10-6 SAL | Yes |
| Shelf Life | 3 years | 3 years | Yes |
| Dimensionsand physicalproperties | Meets ASTM D3577-09requirements | Meets ASTM D3577-09requirements | Yes |
| Freedomfrom holes | Meets ASTM D3577-09requirements of AQL 1.5 | Meets ASTM D3577-09requirements of AQL 1.5 | Yes |
| Powder-Free | Meets Applicable Definition forPowder Free; ≤ 2 mg per glove | Meets Applicable Definition forPowder Free; ≤ 2 mg per glove | Yes |
| Biocompatibility | "Under the conditions of thestudy, not an irritant" and"Under the conditions of thestudy, not a sensitizer" | "Under the conditions of thestudy, not an irritant" and"Under the conditions of thestudy, 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).
§ 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).