(298 days)
The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and /or operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.
SensiCare® Sterile Powder-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Vera (Tested for Use with Chemotherapy Drugs)-Natural Color is to function in the same manner as various other surgical gloves existing in industry today. The proposed SensiCare surgical glove is a disposable device made of synthetic rubber latex intended to be worn by surgeons and /or operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs. It has limited contact duration (< 24 hours), and is in direct contact with the skin. The proposed device is available in three design configurations; it is available in a smooth or micro-roughed (lightly textured) grip, as well as regular and custom fit. A coating of 100% Pure Freeze-Dried Aloe Vera gel and polyacrylate is applied to the inner surface of the glove. The polyacrylate and beaded cuff construction assist in glove stripping and donning.
This document is a 510(k) premarket notification for a medical device: "SensiCare® Sterile Powder-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Vera (Tested for Use with Chemotherapy Drugs)-Natural Color".
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard (Test Set) | Reported Device Performance |
|---|---|
| Freedom from Holes: | |
| ASTM D3577-09e | Meets ASTM D3577-09e |
| ASTM D5151-06 | Meets ASTM D5151-06 |
| Residual Powder: | |
| ASTM D6124-06 & definition for Powder-Free (≤2 mg/glove) | Meets ASTM D6124-06 & definition for Powder-Free; ≤2 mg/glove |
| Primary Irritation: | |
| ISO 10993-10 (No Dermal Irritation Potential) | Meets ISO 10993-10; No Dermal Irritation Potential |
| Dermal Sensitization: | |
| ISO 10993-10 (No Sensitization Potential) | Meets ISO 10993-10; No Sensitization Potential |
| Performance (e.g., Physical Properties): | |
| ASTM D3577-09e | Meets ASTM D3577-09e |
| Chemotherapy Drug Permeation (Breakthrough Detection Time - ASTM D6978-05): | Meets ASTM D6978-05. Specific times listed below: |
| Carmustine | Avg. 15.7 minutes (15.7, 16.3, 17.0) |
| Cisplatin | 240 minutes |
| Cyclophosphamide (Cytoxan) | 240 minutes |
| Dacarbazine (DTIC) | 240 minutes |
| Doxorubicin Hydrochloride | 240 minutes |
| Etoposide (Toposar) | 240 minutes |
| Fluorouracil | 240 minutes |
| Ifosfamide | 240 minutes |
| Methotrexate | 240 minutes |
| Mitomycin C | 240 minutes |
| Paclitaxel (Taxol) | 240 minutes |
| Thiotepa | Avg. 15.3 minutes (15.3, 15.3, 15.3) |
| Vincristine Sulfate | 240 minutes |
| Dimensions & Tolerances: | |
| ASTM D3577-09e | Meets ASTM D3577-09e |
| FDA Medical Glove Guidance Manual | Meets FDA Medical Glove Guidance Manual |
Note: The document explicitly states a "WARNING: Do not use with Carmustine and Thiotepa" despite reporting permeation times, indicating these times are likely too short for safe use.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each test (e.g., number of gloves tested for holes, powder, or chemotherapy permeation). It references standards like ASTM D3577-09e, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05, which would define the required sample sizes for such tests.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are non-clinical (laboratory-based performance testing of the device itself) and would have been conducted by the manufacturer or a contracted testing facility to demonstrate compliance with the referenced standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for these device performance tests is established by objective, standardized measurements and adherence to specified test methods within the ASTM and ISO standards, rather than expert consensus on interpretation. For example, breakthrough detection time for chemotherapy drugs is a direct measurement, and a glove either passes or fails based on the objective criteria of the standard.
4. Adjudication Method for the Test Set
Not applicable. As described above, these are objective performance tests with defined pass/fail criteria from international and national standards (ASTM, ISO). There is no "adjudication" in the sense of reconciling subjective expert opinions.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. This document describes the non-clinical performance testing of a surgical glove, not an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not relevant or applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical device (surgical glove), not a software algorithm. Therefore, "standalone algorithm-only performance" is not relevant.
7. Type of Ground Truth Used
The ground truth used for these tests is based on objective, standardized measurements and compliance with established performance criteria defined in international and national standards (ASTM D3577-09e, ASTM D5151-06, ASTM D6124-06, ASTM D6978-05, ISO 10993-10). These are quantifiable metrics (e.g., length, width, thickness, freedom from holes, residual powder, breakthrough detection time, biological response like irritation/sensitization).
8. Sample Size for the Training Set
Not applicable. This device is a physical product (surgical glove), not a machine learning model or algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, and they are the most prominent element of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 3, 2015
Medline Industries, Inc. Claire Wellinghoff Regulatory Affairs Specialist One Medline Place Mundelein, IL 60060
Re: K150238
Trade/Device Name: SensiCare® Sterile Powder-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Vera (Tested for Use with Chemotherapy Drugs)-Natural Color Regulation Number: 21 CFR 878.4460
Regulation Name: Surgeon's glove Regulatory Class: Class I Product Code: KGO Dated: October 30, 2015 Received: November 9, 2015
Dear Ms. Claire Wellinghoff:
This letter corrects our substantially equivalent letter of November 27, 2015.
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
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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 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" (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 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 vours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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)
Device Name
SensiCare Sterile Powder-Free Polyisoprene Surgical Glove with Aloe Vera (Tested for Use with Chemotheray Drugs)-Natural Color
Indications for Use (Describe)
The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and /or operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
The following chemicals have been tested with these gloves.
Carmustine Avg. 15.7 (15.7,16.3,17.0) Cisplatin 240 min. Cyclophosphamide (Cytoxan) 240 min. Dacarbazine (DTIC) 240 min. Doxorubicin Hydrochloride 240 min. Etoposide (Toposar) 240 min. Fluorouracil 240 min. Ifosfamide 240 min. Methotrexate 240 min. Mitomycin C 240 min. Paclitaxel (Taxol) 240 min. Thiotepa Avg. 15.3 min. (15.3.15.3.15.3) Vincristine Sulfate 240 min.
WARNING: Do not use with Carmustine and Thiotepa
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized white cross. The cross is formed by four lines converging at a central point, creating a star-like shape. The overall design is clean and professional, reflecting Medline's brand identity.
edline Industries. Inc One Medline Place Mundelein. II 60060
SECTION 5 510(K) SUMMARY AS REQUIRED PER 21 CFR 807.92(C)
Submitter / 510(k) Sponsor
Medline Industries, Inc. 1 Medline Place Mundelein. IL 60060 Registration Number: 1417592
Contact Person
Claire Wellinghoff Regulatory Affairs Specialist Phone: 847-643-4071 Fax: 847-643-4482
Summary Preparation Date November 27, 2015
Type of 510(k) Submission Traditional
Device Name / Classification
Name of Device: SensiCare® Powder-Free Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera (Tested for Use with Chemotherapy Drugs)-Natural Color Proprietary Name: SensiCare® Powder-Free Polymer Coated Polyisoprene Surgical Gloves. Sterile. Coated with Aloe Vera (Tested for Use with Chemotherapy Drugs)-Natural Color Common Name: Surgeon's Glove Device Class :I Classification Name: Surgeon's Glove (21 CFR 878.4460) Product Code: KGO Classification Panel: General Hospital
Predicate Device
K111139 - Derma Prene IsoTouch Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs
Device Description
SensiCare® Sterile Powder-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Vera (Tested for Use with Chemotherapy Drugs)-Natural Color is to function in the same manner as various
CONFIDENTIAL
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Image /page/4/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in white, stacked on top of a white star-like symbol with four points. The background is a solid dark blue color. There is a gray bar on the right side of the logo.
Aedline Industries. Inc One Medline Place Mundelein. IL 60060
other surgical gloves existing in industry today. The proposed SensiCare surgical glove is a disposable device made of synthetic rubber latex intended to be worn by surgeons and /or operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs. It has limited contact duration (< 24 hours), and is in direct contact with the skin. The proposed device is available in three design configurations; it is available in a smooth or micro-roughed (lightly textured) grip, as well as regular and custom fit. A coating of 100% Pure Freeze-Dried Aloe Vera gel and polyacrylate is applied to the inner surface of the glove. The polyacrylate and beaded cuff construction assist in glove stripping and donning. Please refer to the table below for a stand-alone comparison of the three glove design configurations that are the subject of this submission.
Stand-Alone Comparison Table
| Glove Design Configurations | ||||
|---|---|---|---|---|
| DeviceCharacteristics | SensiCare withAloe SurgicalGlove | SensiCare LightlyTextured (LT) withAloe Surgical Glove | SensiCare LightlyTextured (LT) withAloe, Custom FitSurgical Glove | ComparisonAnalysis |
| Glove ModelNumbers | MSG1055MSG1060MSG1065MSG1070MSG1075MSG1080MSG1085MSG1090 | MSG1155MSG1160MSG1165MSG1170MSG1175MSG1180MSG1185MSG1190 | MSG1170CMSG1175CMSG1180CMSG1185C | N/A |
| Description | Powder-freeSterileNatural color | Powder-freeSterileNatural color | Powder-freeSterileNatural color | Same |
| Coating | Aloe Vera andPolyacrylateCoating | Aloe Vera andPolyacrylate Coating | Aloe Vera andPolyacrylate Coating | Same |
| Fit | Regular | Regular | Custom | Different |
| Texture | Smooth | Lightly Textured | Lightly Textured | Different |
| Device Class | Class I | Class I | Class I | Same |
| Material | Polyisoprene | Polyisoprene | Polyisoprene | Same |
| FingerThickness | 0.10 mils | 0.10 mils | 0.10 mils | Same |
| Packaging | 25/box; 100/case | 25/box; 100/case | 25/box; 100/case | Same |
| Labeling | Glove Pouch indispenser box | Glove Pouch indispenser box | Glove Pouch indispenser box | Same |
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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with a stylized cross symbol to the right of the text. The background is a solid blue color. The logo is simple and modern, and the colors are clean and professional.
Medline Industries, Inc. One Medline Place Mundelein, IL 60060
| Size | 5.5 | 5.5 | 7 | Same **Fewer sizesoffered forSensiCare withAloe SurgicalGlove LightlyTextured (LT),Custom Fit |
|---|---|---|---|---|
| 6 | 6 | 7.5 | ||
| 6.5 | 6.5 | 8 | ||
| 7 | 7 | 8.5 | ||
| 7.5 | 7.5 | |||
| 8 | 8 | |||
| 8.5 | 8.5 | |||
| 9 | 9 | |||
| Labeling | Glove Pouch indispenser box | Glove Pouch indispenser box | Glove Pouch indispenser box | Same |
| ResidualPowder | Meets ASTMD6124-06 &definition forPowder-Free; ≤2mg/glove | Meets ASTM D6124-06 & definition forPowder-Free; ≤2mg/glove | Meets ASTM D6124-06 & definition forPowder-Free; ≤2mg/glove | Same |
| PrimaryIrritation | Meets ISO 10993-10No DermalIrritation Potential | Meets ISO 10993-10No Dermal IrritationPotential | Meets ISO 10993-10No Dermal IrritationPotential | Same |
| DermalSensitization | Meets ISO 10993-10No SensitizationPotential | Meets ISO 10993-10No SensitizationPotential | Meets ISO 10993-10No SensitizationPotential | Same |
| Performance | Meets ASTMD3577-09e | Meets ASTM D3577-09e | Meets ASTM D3577-09e | Same |
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Image /page/6/Picture/0 description: The image is a logo for Medline. The logo consists of the word "MEDLINE" in white, set against a dark blue square background. A white star-like symbol is behind the text. The star has four points, with the top and bottom points being longer than the side points.
Medline Industries, Inc.
One Medline Place
Mundelein, IL 60060
Intended Use
The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and /or operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
The following chemicals have been tested with these gloves.
| Carmustine | Avg. 15.7 (15.7,16.3,17.0) |
|---|---|
| Cisplatin | 240 min. |
| Cyclophosphamide (Cytoxan) | 240 min. |
| Dacarbazine (DTIC) | 240 min. |
| Doxorubicin Hydrochloride | 240 min. |
| Etoposide (Toposar) | 240 min. |
| Fluorouracil | 240 min. |
| Ifosfamide | 240 min. |
| Methotrexate | 240 min. |
| Mitomycin C | 240 min. |
| Paclitaxel (Taxol) | 240 min. |
| Thiotepa | Avg. 15.3 min. (15.3,15.3,15.3) |
| Vincristine Sulfate | 240 min. |
WARNING: Do not use with Carmustine and Thiotepa
Summary of Technological Characteristics
The information within this submission demonstrates that there are no significant differences in technological characteristics of the subject device and the predicate devices. The subject device has the same functionality and indications as the predicate device listed. The comparative table below (Table 1) offers details pointing to similarities and differences between the proposed and predicate device.
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| DeviceCharacteristic | Proposed Device | Predicate Device | ComparisonAnalysis:SubstantiallyEquivalent? |
|---|---|---|---|
| Product Name | SensiCare® Sterile Powder-Free Polymer CoatedPolyisoprene Surgical Glove, Coated with Aloe Vera(Tested for Use with Chemotherapy Drugs)-Natural Color | Derma Prene® Isotouch® Green Sterile Powder-FreePolyisoprene Surgical Gloves Tested for Use withChemotherapy Drugs | N/A |
| DesignConfigurations | SensiCare With Aloe Surgical GloveSensiCare Lightly Textured (LT) With Aloe SurgicalGloveSensiCare Lightly Textured (LT) With Aloe, Custom FitSurgical Glove | N/A | N/A |
| 510(k) Reference | TBD | K111139 | N/A |
| Product Owner | Medline Industries | Ansell Healthcare Products LLC | Different |
| Product Code | KGO | KGO | Identical |
| Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Identical |
| Device Class | Class I | Class I | Identical |
| Intended Use | The surgeon's glove is a device made of synthetic rubberintended to be worn by operating room personnel toprotect a surgical wound from contamination, and aretested for use with chemotherapy drugs.Chemotherapy Drug Permeation (Breakthrough DetectionTime) in MinutesThe following chemicals have been tested with thesegloves.Carmustine Avg. 15.7 (15.7,16.3,17.0)Cisplatin 240 min.Cyclophosphamide 240 min.Dacarbazine (DTIC) 240 minDoxorubicin Hydrochloride 240 min.Etoposide (Toposar) 240 min.Fluorouracil 240 min.Ifosfamide 240 min.Methotrexate 240 min.Mitomycin C 240 min.Paclitaxel (Taxol) 240 min.Thiotepa Avg. 15.3 min. (15.3,15.3,15.3)Vincristine Sulfate 240 min. | These gloves are intended to be worn by operatingroom personnel to protect a surgical wound fromcontamination, and are tested for use withchemotherapy drugs.Chemotherapy Drug Permeation(average breakthrough detection time in minutes)(ASTM D6978-05)*Carmustine 15.5Cyclophosphamide >240Doxorubicin Hydrochloride >240Etoposide (Toposar) >2405-Fluorouracil >240Paclitaxel (Taxol) >240*ThioTEPA 15.5Methotrexate >240Vincristine Sulfate >240Please note that Carmustine and ThioTEPA have anextremely low permeation time of 15.5 minutes. | SubstantiallyEquivalent |
| DeviceCharacteristic | Proposed Device | Predicate Device | ComparisonAnalysis:SubstantiallyEquivalent? |
| Device Description | Is a disposable device made of synthetic rubber latexintended to be worn by surgeons and /or operatingroom personnel to protect a surgical wound fromcontamination, and are tested for use withchemotherapy drugs. It has limited contact duration( $\le$ 24 hours), and is in direct contact with the skinThe proposed device is available in three designconfigurations; it is available in a smooth or micro-roughed (lightly textured) grip, as well as regular andcustom fit. A coating of 100% Pure Freeze-DriedAloe Vera gel and polyacrylate is applied to the innersurface of the glove. The polyacrylate and beadedcuff construction assist in glove stripping anddonning. | Is a disposable device made of synthetic latex rubberthat is intended to be worn by operation roompersonnel to protect a surgical wound fromcontamination, and is tested for use withchemotherapy drugs. A coating of AliphaticPolyester Polyurethane is applied to the inner surfaceof the glove to make donning easy. | SubstantiallyEquivalent |
| Powder-Free | Yes. Meets ASTM D6124-06 and definition for Powder-Free; $\le$ 2 mg per glove | Yes. Meets definition for Powder Free; $\le$ 2 mg perglove | SubstantiallyEquivalent |
| Coating | Aloe Vera and Polyacrylate coating | Polyurethane coating | Different (SeeReference DeviceK102177) |
| Materials | Polyisoprene | Polyisoprene | Identical |
| Color | Natural Colored | Green | Different (SeeReference DeviceK102177) |
| Sterility vs. Non-Sterile | Sterile | Sterile | Identical |
| Disposable vs. Non-Disposable | Disposable | Disposable | Identical |
| Single Use vs.Reusable | Single Use | Single Use | Identical |
| DeviceCharacteristic | Proposed Device | Predicate Device | ComparisonAnalysis:SubstantiallyEquivalent? |
| Sizes | 5.56.06.57.07.58.08.59.0 | 5.56.06.57.07.58.08.59.0 | Identical |
| Freedom fromHoles | Meets ASTM D3577-09e & ASTM D5151-06 | Meets ASTM D3577-09e & ASTM D5151-06 | SubstantiallyEquivalent |
| Dimension withTolerances | Meets requirements of:ASTM D3577-09eFDA Medical Glove Guidance Manual(See Table 2 below) | Meets requirements of:ASTM 3577-09eFDA Medical Glove Guidance Manual | SubstantiallyEquivalent |
| Performance | Meets ASTM D3577-09e | Meets ASTM D3577-09e | SubstantiallyEquivalent |
| Dimensions andPhysical Properties | Meets ASTM D3577-09e | Meets ASTM D3577-09e | SubstantiallyEquivalent |
| Tested for Use W/ChemotherapyDrugs | Meets ASTM D6978-05 | Meet ASTM D6978-05 | SubstantiallyEquivalent |
| Biocompatibility | Meet ISO 10993-10; Dermal Sensitization and PrimarySkin Irritation Study | Meet ISO 10993-10; Dermal Sensitization andPrimary Skin Irritation Study | SubstantiallyEquivalent |
| Labeling | Glove Pouch in Dispenser Box | Glove Pouch in Dispenser Box | Identical |
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Image /page/10/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is in white, and to the right of the text is a white symbol that resembles a four-pointed star or a stylized cross. There is a gray bar on the right side of the image.
ledline Industries, Inc. One Medline Place Mundelein. IL 60060
| Series | MSG10XX | MSG11XX | MSG11XXC |
|---|---|---|---|
| Length, mm(minimum) | Length, mm(minimum) | Length, mm(minimum) | |
| Size | |||
| 5.5 | 278 | 278 | N/A* |
| 6 | 280 | 280 | N/A* |
| 6.5 | 280 | 280 | N/A* |
| 7 | 283 | 283 | 283 |
| 7.5 | 287 | 287 | 287 |
| 8 | 288 | 288 | 288 |
| 8.5 | 290 | 290 | 290 |
| 9 | 290 | 290 | N/A* |
| Width, mm | Width, mm | Width, mm | |
| Size | |||
| 5.5 | 70 ± 6 | 70 ± 6 | N/A* |
| 6 | 76 ± 6 | 76 ± 6 | N/A* |
| 6.5 | 83 ± 6 | 83 ± 6 | N/A* |
| 7 | 89 ± 6 | 89 ± 6 | 89 ± 6 |
| 7.5 | 95 ± 6 | 95 ± 6 | 95 ± 6 |
| 8 | 102 ± 6 | 102 ± 6 | 102 ± 6 |
| 8.5 | 108 ± 6 | 108 ± 6 | 108 ± 6 |
| 9 | 116 | 116 | N/A* |
Table 2. Dimensions and Tolerances
*Glove model not offered in this size
Summary of Non-Clinical Testing
The safety and effectiveness of the subject device is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this submission. The subject device meets the applicable requirements for surgeon's gloves with regard to the dimensions and sizes. physical properties, freedom from holes, and powder residues as found in the following standards: ASTM D3577-09e. ASTM D5151-06, and ASTM D6124-06. In addition, the proposed device demonstrates device safety in accordance with relevant ISO 10993-10 test methods as there was no dermal sensitization and primary skin irritation was observed. Additionally, the proposed surgical glove was tested for permeation by chemotherapy drugs in accordance with ASTM D6978-05. Results show that the proposed surgical glove meets the criteria in accordance with ASTM D6978-05.
Summary of Clinical Testing
Not applicable. No clinical testing was performed.
Conclusion
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Image /page/11/Picture/0 description: The image features the Medline logo, which consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized star symbol. The star is composed of four triangular shapes converging at a central point. The logo is set against a solid blue background, with a small gray rectangle visible in the upper right corner.
Medline Industries, Inc. One Medline Place Mundelein. IL 60060
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, the SensiCare® Powder-Free Polymer Coated Polyisoprene Surgical Glove, Sterile, Coated with Aloe Vera (Tested for Use with Chemotherapy Drugs)-Natural Color is as safe, as effective and performs as well as the predicate device K111139 based on the conclusions drawn from the nonclinical and clinical tests. The subject device has been tested against the ASTM and ISO standards listed, and met the requirements in accordance with those standards. Additional comparisons found herein show that the subject device is substantially equivalent to the predicate.
§ 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).