(139 days)
Gammex Non Latex PI White Surgical Gloves Tested for Use with Chemotherapy Drugs are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Gammex Non Latex Pl White Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy. Ansell has performed independent laboratory testing on the already cleared device to support a labeling modification for the subject device that the gloves are safe and ling chemotherapy agents
This document is a 510(k) Premarket Notification from the FDA for a medical device: Gammex Non Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs. The document details the substantial equivalence determination for the device.
Based on the provided text, the device in question is surgical gloves, not an AI/algorithm-based diagnostic or assistive device. Therefore, many of the requested elements of the prompt (ground truth establishment for training/test sets, expert adjudication, MRMC studies, AI effect size, etc.) are not applicable to this type of medical device submission.
The "acceptance criteria" for a physical device like a glove are typically performance specifications based on established standards (e.g., ASTM standards for dimensions, physical properties, lack of holes, chemical permeation). The "study that proves the device meets the acceptance criteria" refers to non-clinical laboratory testing.
Here's an attempt to answer the prompt using the available information, noting where AI-specific questions are not relevant:
Device: Gammex Non Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs
Type of Study: Non-clinical laboratory testing to assess the physical properties, chemical permeation resistance, and biocompatibility of the surgical gloves, demonstrating substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from ASTM standards/device specifications) | Reported Device Performance (Result Summary) |
|---|---|
| Dimensions (ASTM D3577) | Meets ASTM D3577 requirements for length, width, and thickness. |
| - Length: Minimum 265mm | Average 301mm |
| - Palm Width (per size): e.g., 5.5 (70±6mm), 6.0 (76±6mm) etc. | Average values: 5.5 (74mm), 6.0 (80mm), 6.5 (86mm), 7.0 (92mm), 7.5 (97mm), 8.0 (103mm), 8.5 (111mm), 9.0 (119mm) |
| - Thickness (Finger): Minimum 0.10mm | 0.233mm |
| - Thickness (Palm): Minimum 0.10mm | 0.172mm |
| - Thickness (Cuff): Minimum 0.10mm | 0.212mm |
| Physical Properties (ASTM D3577-09) | Meets ASTM D3577-09 requirements for tensile strength, ultimate elongation, and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves. |
| Freedom from holes (ASTM D3577-09, ASTM D5151-06) | Meets ASTM D3577-09 and ASTM D5151-06 requirements of AQL 1.5. (Note: Comparison table implies a stricter AQL for subject device at 0.65 vs. predicate's 1.5, suggesting better performance). |
| Powder-Free (ASTM D3577-09, ASTM D6124-06) | Meets Applicable requirement for Powder Free; ≤ 2 mg per glove. Average residual powder content for the glove during process validation is 0.16mg per glove. |
| Sterility (ANSI/AAMI/ISO 11137-1:2006) | Meets ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6 SAL. |
| Biocompatibility: | |
| - ISO in vitro cytotoxicity (ISO 10993-5:2009) | Under the conditions of the study, the device was found to be cytotoxic and therefore the device extracts were evaluated by ISO 10993-11 - Test for systemic toxicity. From Acute Systemic Toxicity device extracts, the device extracts did not elicit a systemic response in the animal model. (Note: Follow-up systemic toxicity test showed no systemic effect, addressing initial in vitro cytotox result) |
| - 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. |
| - ISO Systemic Toxicity Study (ISO 10993-11:2006) | Under the conditions of the study, there was no mortality or evidence of systemic toxicity. |
| Chemotherapy Permeation Standard (ASTM D6978-05(2013)) | Under the conditions of the study, the permeation is acceptable for most tested drugs (>240 minutes breakthrough time for most). Specific low breakthrough times noted for Carmustine (10.2 minutes) and Thiotepa (11.5 minutes), leading to a warning not to use with these drugs. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Testing: The document does not explicitly state the total number of gloves or samples tested for each criterion. It mentions "Minimum Breakthrough Detection Time (Sample 1,2,3)" in one table (page 5), implying at least 3 samples were used for chemotherapy permeation testing for each chemical. Standard testing protocols (like ASTM) would dictate specific sample sizes for each test.
- Data Provenance: The testing was "independent laboratory testing" performed by Ansell. The country of origin of the data is not specified, but the submission is to the U.S. FDA by an LLC based in Reno, Nevada, USA. The data is retrospective in the sense that it was collected prior to this submission for regulatory review.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a physical device like surgical gloves, "ground truth" is established by adherence to recognized national and international testing standards (e.g., ASTM, ISO). These standards define the methodologies and acceptance limits for physical, chemical, and biological performance. Experts involved would be laboratory technicians and engineers specializing in materials testing and biocompatibility, but not in the sense of clinical "expert readers" for diagnostic images.
4. Adjudication method for the test set:
- Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing consensus "ground truth" in subjective assessments, such as radiology interpretations or clinical diagnoses. For physical device testing, results are typically quantitative measurementsagainst predefined criteria.
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:
- Not Applicable. This is a physical medical device (surgical gloves), not an AI-based diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm. Standalone performance is assessed through the non-clinical laboratory tests showing the glove's inherent properties and resistance.
7. The type of ground truth used:
- Standard-based performance metrics and established laboratory methods. The "ground truth" for this device is based on meeting the performance requirements outlined in:
- ASTM D3577 (Standard Specification for Rubber Surgical Gloves)
- ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- ANSI/AAMI/ISO 11137-1:2006 (Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices)
- ISO 10993 (Biological evaluation of medical devices), specifically Parts 5 (cytotoxicity), 10 (irritation and sensitization), and 11 (systemic toxicity).
- ASTM D6978-05 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs).
8. The sample size for the training set:
- Not Applicable. There is no "training set" in the context of an AI algorithm for this type of device submission. The device itself is manufactured; it does not "learn" from data.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 23, 2019
Ansell Healthcare Products, LLC. Don Cronk Director, Regulatory Affairs for the Americas 2301 Robb Drive Reno, Nevada 89523
Re: K190018
Trade/Device Name: Gammex Non Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: April 16, 2019 Received: April 17, 2019
Dear Don Cronk:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For David Krause, PhD Acting Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190018
Device Name
Gammex Non Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
Gammex Non Latex PI White Surgical Gloves Tested for Use with Chemotherapy Drugs are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
| Test Chemotherapy drug & Concentration | Average Breakthrough Detection Times(Minutes) |
|---|---|
| Blenoxane, 15 mg/ml | >240 |
| Busulfan, 6 mg/ml | >240 |
| Carmustine (BCNU), 3.3 mg/ml | 10.2 |
| Cisplatin , 1.0 mg/ml | >240 |
| Cyclophosphamide (Cytoxan), 20.0 mg/ml | >240 |
| Cytarabine , 100 mg/ml | >240 |
| Dacarbazine (DTIC), 10.0 mg/ml | >240 |
| Daunorubicin , 5 mg/ml | >240 |
| Docetaxel, 10.0 mg/ml | >240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | >240 |
| Etoposide (Toposar), 20.0 mg/ml | >240 |
| Fludarabine , 25 mg/ml | >240 |
| Fluorouracil , 50.0 mg/ml | >240 |
| Gemcitabine (Gemzar), 38 mg/ml | >240 |
| Idarubicin , 1 mg/ml | >240 |
| Ifosfamide , 50.0 mg/ml | >240 |
| Irinotecan , 20.0 mg/ml | >240 |
| Mechlorethamine HCI, 1.0 mg/ml | >240 |
| Melphalan, 5 mg/ml | >240 |
| Methotrexate , 25 mg/ml, | >240 |
| Mitomycin C, 0.5 mg/ml | >240 |
| Mitoxantrone, 2.0 mg/ml | >240 |
| Oxaliplatin , 2.0 mg/ml | >240 |
| Paclitaxel (Taxol), 6.0 mg/ml | >240 |
| Paraplatin , 10 mg/ml | >240 |
| Thiotepa , 10.0 mg/ml | 11.5 |
| Vincristine Sulfate, 1.0 mg/ml | >240 |
| Ellence 2 mg/ml | >240 |
| Rituximab, 10 mg/ml | >240 |
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 10.2 minutes and Thiotepa: 11.5 minutes.
Warning: Do not use with Carmustine and Thiotepa
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] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510K Summary K190018
Submitter:
Ansell Healthcare Products LLC. 2301 Robb Drive Reno, NV 89523 USA
Contact Person:
Don Cronk Director of Regulatory Affairs Phone: 775-470-7106 don.cronk@ansell.com
Date Prepared: April 16th, 2019
Name of Device
Trade Names:
| for Use with Chemotherapy Drugs | |
|---|---|
| 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 |
| 510k: | K190018 |
Legally Marketed Predicate Device
K111139 - Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs.
Gammex Non Latex Polyisoprene White Surgical Gloves Tested
Device Description
Gammex Non Latex Pl White Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy. Ansell has performed independent laboratory testing on the already cleared device to support a labeling modification for the subject device that the gloves are safe and ling chemotherapy agents
Indication for Use Statement
Gammex Non Latex PI White Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
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Chemotherapy drug Permeation
(Average breakthrough detection time in minutes) (ASTM D6978-05)
| TEST CHEMOTHERAPY DRUG ANDCONCENTRATION | MINIMUMBREAKTHROUGHDETECTION TIME(Sample 1,2,3)(Minutes) |
|---|---|
| Blenoxane (15 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Carmustine (BCNU) (3.3 mg/ml) | 10.2 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Daunorubicin (5 mg/ml) | >240 |
| Docetaxel (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (Toposar) (20.0 mg/ml) | >240 |
| Fludarabine (25 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Gemcitabine (Gemzar) (38 mg/ml) | >240 |
| Idarubicin (1 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Irinotecan (20.0 mg/ml) | >240 |
| Mechlorethamine HCI (1.0 mg/ml) | >240 |
| Melphalan (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Oxaliplatin (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Paraplatin (10 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 11.5 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Ellence (2 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
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Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 10.2 minutes and Thiotepa: 11.5 minutes.
Warning: Do not use with Carmustine and Thiotepa
Technological Characteristics
| Technical Characteristic Comparison Table | |||
|---|---|---|---|
| Predicate Device | Subject Device | Comparison | |
| Trade Name | Derma Prene Isotouch Green SterilePowder-Free Polyisoprene SurgicalGloves, Tested for Use withChemotherapy Drugs. | Gammex® Non-Latex PI White | Different |
| 510(k) Number | K111139 | K190018 | Different |
| Submitter | Ansell Healthcare Products LLC | Ansell Healthcare Products LLC | Same |
| Product Code | KGO | KGO | Same |
| RegulationNumber | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| RegulationName | Non-powdered Surgeon's glove | Non-powdered Surgeon's glove | Same |
| Indicationsfor Use | Indications For Use:These gloves are intended to beworn by operating room personnelto protect a surgical wound fromcontamination, and are tested foruse with chemotherapy drugs. | These gloves are intended to be worn by operatingroom personnel to protect a surgical wound fromcontamination. These gloves were tested for usewith Chemotherapy Drugs as per ASTM D6978-05Standard Practice for Assessment of Medical Glovesto Permeation by Chemotherapy Drugs.Tested chemotherapy drugs are as follows: | Similarwith theexceptionof addedChemoth-erapydrugs |
| Chemotherapy Drug Permeation(average breakthrough detectiontime in minutes) (ASTM D6978-05) | TEST CHEMOTHERAPYDRUG ANDCONCENTRATION | MINIMUMBREAKTHROUGHDETECTIONTIME | |
| *Carmustine15.5Cyclophosphamide>240Doxorubicm Hydrochloride >240Etoposide (Toposar)>2405-Fluorouracil>240Paclitaxel (Taxol)>240*ThioTEPA Methotrexate15.5Vincristine Sulfate>240 | Blenoxane (15>240mg/ml)Busulfan (6 mg/ml)>240Carmustine (BCNU)10.2(3.3 mg/ml)Cisplatin (1.0 mg/ml)>240Cyclophosphamide>240(Cytoxan) (20.0 |
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| Please note that Carmustine andThioTEPA have an extremely lowpermeation time of 15.5 minutes. | Cytarabine (100mg/ml) | >240 |
|---|---|---|
| Dacarbazine (DTIC)(10.0 mg/ml) | >240 | |
| Daunorubicin (5mg/ml) | >240 | |
| Docetaxel (10.0mg/ml) | >240 | |
| DoxorubicinHydrochloride (2.0mg/ml) | >240 | |
| Etoposide (Toposar)(20.0 mg/ml) | >240 | |
| Fludarabine (25mg/ml) | >240 | |
| Fluorouracil (50.0mg/ml) | >240 | |
| Gemcitabine(Gemzar) (38 mg/ml) | >240 |
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| Idarubicin (1 mg/ml) | >240 | ||
|---|---|---|---|
| Ifosfamide (50.0mg/ml) | >240 | ||
| Irinotecan (20.0mg/ml) | >240 | ||
| Mechlorethamine HCI(1.0 mg/ml) | >240 | ||
| Melphalan (5 mg/ml) | >240 | ||
| Methotrexate (25mg/ml) | >240 | ||
| Mitomycin C (0.5mg/ml) | >240 | ||
| Mitoxantrone (2.0mg/ml) | >240 | ||
| Oxaliplatin (2.0mg/ml) | >240 | ||
| Paclitaxel (Taxol) (6.0mg/ml) | >240 | ||
| Paraplatin (10 mg/ml) | >240 | ||
| Thiotepa (10.0 mg/ml) | 11.5 | ||
| Vincristine Sulfate (1.0mg/ml) | >240 | ||
| Ellence (2 mg/ml) | >240 | ||
| Rituximab (10 mg/ml) | >240 | ||
| Prescriptionor Over-TheCounter-Use | Over-The-Counter-Use | Over-The-Counter-Use | Same |
| Materials | Synthetic polyisoprene rubber | Synthetic polyisoprene rubber | Same |
| Coating | Polyurethane polymer inner coating toaid donning | Polyurethane polymer inner coating toaid donning | Same |
| Performance | Meets ASTM D3577-09 | Same | Same |
| Design | Single use | Single use | Same |
| Sterile | Sterile | Same | |
| Powder-free | Powder-free | Same | |
| Hand Specific | Hand Specific | Same | |
| Beaded cuff | Beaded cuff | Same | |
| Color | Green | White | Different |
| Dimensions andphysicalproperties | Meets ASTM D3577 | Meets ASTM D3577 | Same |
| Sterilizationmethod | Radiation | Radiation | Same |
| SterilityAssurance Level(SAL) | 10-6 SAL | 10-6 SAL | Same |
| Freedom fromholes | Meets ASTM D3577-09(2015)Inspection level/AQL: GI/AQL 1.5 | Meets ASTM D3577-09(2015)Inspection level/AQL: GI/AQL 0.65 | Similar |
| Powder-Free | Meets ASTM D 6124-06. MeetsApplicable Definition for Powder Free; ≤ 2mg per glove | Meets ASTM D 6124-06 The averagedresidual powder content for the gloveduring process validation is 0.16mg perglove | Same |
| Primary SkinIrritationISO 10993-10:2010 | Under the conditions of the study (perISO 10993-10), the device is not anirritant | Under the conditions of the study (perISO 10993-10), the device is not anirritant | Same |
| DermalSensitization -ISO 10993-10:2010 | Under the conditions of the study (perISO 10993-10), not a sensitizer | Under the conditions of the study (perISO 10993-10), not a sensitizer | Same |
| Acute SystemicToxicity - ISO10993-11: 2006 | Under the conditions of the study, therewas no mortality or evidence of systemictoxicity | Under the conditions of the study, therewas no mortality or evidence of systemictoxicity | Same |
| Shelf Life | 3 years | 3 years | Same |
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The subject device is manufactured from synthetic polyisoprene rubber with polyurethane polymer inner coating to aid donning. The predicate device is manufactured from synthetic polyisoprene rubber with polyurethane polymer inner coating to aid donning.
Non-Clinical Testing Summary:
Non-clinical testing was performed to verify that the subject device will meet the acceptance criteria of the performance test shown below.
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| Technological Characteristics | Standard/Test/FDA Guidance | Result Summary |
|---|---|---|
| Dimensions | ASTM D3577 | Meets ASTM D3577requirements for length,width and thickness |
| Length | Minimum 265mm | Average 301mm |
| Palm Width (size) | (mm) | Average value in mm |
| 5.5 | 70±6 | 74 |
| 6.0 | 76±6 | 80 |
| 6.5 | 83±6 | 86 |
| 7.0 | 89±6 | 92 |
| 7.5 | 95±6 | 97 |
| 8.0 | 102±6 | 103 |
| 8.5 | 108±6 | 111 |
| 9.0 | 114±6 | 119 |
| Thickness | (mm) | Average value in mm |
| Finger | Minimum 0.10 | 0.233 |
| Palm | Minimum 0.10 | 0.172 |
| Cuff | Minimum 0.10 | 0.212 |
| Physical Properties | ASTM D3577-09 | Meets ASTM D3577-09requirements for tensilestrength, ultimateelongation and stress at500% elongation beforeand after accelerated agingfor synthetic surgical gloves |
| Freedom from holes | ASTM D3577-09ASTM D5151-06 | Meets ASTM D3577-09and ASTM D5151- 06requirements of AQL 1.5 |
| Powder-Free | ASTM D3577-09ASTM D6124-06 | Meets Applicablerequirement for PowderFree; ≤ 2 mg per glove |
| Sterility | ANSI/AAMI/ISO 11137-1:2006 | Meets ANSI/AAMI/ISO11137-1:2006 requirementof 10-6SAL |
| Technological Characteristics | Standard/Test/FDA Guidance | Result Summary |
| Biocompatibility: | ||
| ISO in vitro cytotoxicity | ISO 10993-5:2009 | Under the conditions of thestudy, the device was foundto be cytotoxic andtherefore the deviceextracts were evaluated byISO 10993-11 - Test forsystemic toxicity. FromAcute Systemic Toxicitydevice extracts, the deviceextracts did not elicit asystemic response in theanimal model. |
| ISO Skin Irritation Study | ISO 10993-10:2010 | Under the conditions of thestudy, not an irritant |
| ISO Maximization SensitizationStudy | ISO 10993-10:2010 | Under the conditions of thestudy, not a sensitizer |
| ISO Systemic Toxicity Study | ISO 10993-11:2006 | Under the conditions of thestudy, there was nomortality or evidence ofsystemic toxicity |
| Chemotherapy PermeationStandard | ASTM D6978 - 05(2013) | Under the conditions of thestudy, the permeation isacceptable |
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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, ASTM D5151 and ASTM D6124. The subject device passes biological reactivity testing for dermal sensitization, irritation, and acute systemic toxicity in accord with the ISO 10993-10 and ISO 10993-11.
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device.
§ 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).