← Product Code [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO) · K150238 # SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color (K150238) _Medline Industries, Inc. · KGO · Nov 27, 2015 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K150238 ## Device Facts - **Applicant:** Medline Industries, Inc. - **Product Code:** [KGO](/submissions/SU/subpart-e%E2%80%94surgical-devices/KGO.md) - **Decision Date:** Nov 27, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4460 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery ## 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. ## Device Story Disposable synthetic polyisoprene surgical glove; worn by surgeons/OR personnel to protect surgical wounds from contamination. Features inner coating of 100% pure freeze-dried Aloe Vera gel and polyacrylate to assist in donning/stripping. Available in smooth or micro-roughed (lightly textured) grip; regular or custom fit. Tested for chemotherapy drug permeation per ASTM D6978-05. Provides barrier protection during surgical procedures. Healthcare providers use gloves as standard PPE; output is physical barrier protection. Benefits include reduced risk of wound contamination and protection against chemotherapy agents (excluding specific drugs). ## Clinical Evidence No clinical testing was performed. Safety and effectiveness supported by bench testing, including physical properties (ASTM D3577-09e), freedom from holes (ASTM D5151-06), powder residue (ASTM D6124-06), biocompatibility (ISO 10993-10), and chemotherapy drug permeation (ASTM D6978-05). ## Technological Characteristics Material: Polyisoprene. Coating: Aloe Vera gel and polyacrylate. Form factor: Sterile, disposable, powder-free surgical glove. Dimensions/tolerances per ASTM D3577-09e. Biocompatibility per ISO 10993-10. Chemotherapy permeation testing per ASTM D6978-05. Powder residue ≤ 2 mg/glove per ASTM D6124-06. ## Regulatory 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 IsoTouch Green Sterile Powder-Free Polyisoprene Surgical Gloves ([K111139](/device/K111139.md)) ## Reference Devices - [K102177](/device/K102177.md) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K150238 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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) K150238 # 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 {4}------------------------------------------------ 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 | | | | |---------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------| | Device
Characteristics | SensiCare with
Aloe Surgical
Glove | SensiCare Lightly
Textured (LT) with
Aloe Surgical Glove | SensiCare Lightly
Textured (LT) with
Aloe, Custom Fit
Surgical Glove | Comparison
Analysis | | Glove Model
Numbers | MSG1055
MSG1060
MSG1065
MSG1070
MSG1075
MSG1080
MSG1085
MSG1090 | MSG1155
MSG1160
MSG1165
MSG1170
MSG1175
MSG1180
MSG1185
MSG1190 | MSG1170C
MSG1175C
MSG1180C
MSG1185C | N/A | | Description | Powder-free
Sterile
Natural color | Powder-free
Sterile
Natural color | Powder-free
Sterile
Natural color | Same | | Coating | Aloe Vera and
Polyacrylate
Coating | Aloe Vera and
Polyacrylate Coating | Aloe Vera and
Polyacrylate 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 | | Finger
Thickness | 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 in
dispenser box | Glove Pouch in
dispenser box | Glove Pouch in
dispenser box | Same | {5}------------------------------------------------ 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 sizes
offered for
SensiCare with
Aloe Surgical
Glove Lightly
Textured (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 in
dispenser box | Glove Pouch in
dispenser box | Glove Pouch in
dispenser box | Same | | Residual
Powder | Meets ASTM
D6124-06 &
definition for
Powder-Free; ≤2
mg/glove | Meets ASTM D6124-
06 & definition for
Powder-Free; ≤2
mg/glove | Meets ASTM D6124-
06 & definition for
Powder-Free; ≤2
mg/glove | Same | | Primary
Irritation | Meets ISO 10993-
10
No Dermal
Irritation Potential | Meets ISO 10993-10
No Dermal Irritation
Potential | Meets ISO 10993-10
No Dermal Irritation
Potential | Same | | Dermal
Sensitization | Meets ISO 10993-
10
No Sensitization
Potential | Meets ISO 10993-10
No Sensitization
Potential | Meets ISO 10993-10
No Sensitization
Potential | Same | | Performance | Meets ASTM
D3577-09e | Meets ASTM D3577-
09e | Meets ASTM D3577-
09e | Same | {6}------------------------------------------------ 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. {7}------------------------------------------------ | Device
Characteristic | Proposed Device | Predicate Device | Comparison
Analysis:
Substantially
Equivalent? | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------| | Product Name | SensiCare® Sterile Powder-Free Polymer Coated
Polyisoprene Surgical Glove, Coated with Aloe Vera
(Tested for Use with Chemotherapy Drugs)-Natural Color | Derma Prene® Isotouch® Green Sterile Powder-Free
Polyisoprene Surgical Gloves Tested for Use with
Chemotherapy Drugs | N/A | | Design
Configurations | SensiCare With Aloe Surgical Glove
SensiCare Lightly Textured (LT) With Aloe Surgical
Glove
SensiCare Lightly Textured (LT) With Aloe, Custom Fit
Surgical 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 rubber
intended to be worn by 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 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. | These gloves are intended to be worn by operating
room personnel to protect a surgical wound from
contamination, and are tested for use with
chemotherapy drugs.
Chemotherapy Drug Permeation
(average breakthrough detection time in minutes)
(ASTM D6978-05)
*Carmustine 15.5
Cyclophosphamide >240
Doxorubicin Hydrochloride >240
Etoposide (Toposar) >240
5-Fluorouracil >240
Paclitaxel (Taxol) >240
*ThioTEPA 15.5
Methotrexate >240
Vincristine Sulfate >240
Please note that Carmustine and ThioTEPA have an
extremely low permeation time of 15.5 minutes. | Substantially
Equivalent | | Device
Characteristic | Proposed Device | Predicate Device | Comparison
Analysis:
Substantially
Equivalent? | | Device Description | 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
( $\le$ 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. | Is a disposable device made of synthetic latex rubber
that is intended to be worn by operation room
personnel to protect a surgical wound from
contamination, and is tested for use with
chemotherapy drugs. A coating of Aliphatic
Polyester Polyurethane is applied to the inner surface
of the glove to make donning easy. | Substantially
Equivalent | | 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 per
glove | Substantially
Equivalent | | Coating | Aloe Vera and Polyacrylate coating | Polyurethane coating | Different (See
Reference Device
K102177) | | Materials | Polyisoprene | Polyisoprene | Identical | | Color | Natural Colored | Green | Different (See
Reference Device
K102177) | | Sterility vs. Non-
Sterile | Sterile | Sterile | Identical | | Disposable vs. Non-
Disposable | Disposable | Disposable | Identical | | Single Use vs.
Reusable | Single Use | Single Use | Identical | | Device
Characteristic | Proposed Device | Predicate Device | Comparison
Analysis:
Substantially
Equivalent? | | Sizes | 5.5
6.0
6.5
7.0
7.5
8.0
8.5
9.0 | 5.5
6.0
6.5
7.0
7.5
8.0
8.5
9.0 | Identical | | Freedom from
Holes | Meets ASTM D3577-09e & ASTM D5151-06 | Meets ASTM D3577-09e & ASTM D5151-06 | Substantially
Equivalent | | Dimension with
Tolerances | Meets requirements of:
ASTM D3577-09e
FDA Medical Glove Guidance Manual
(See Table 2 below) | Meets requirements of:
ASTM 3577-09e
FDA Medical Glove Guidance Manual | Substantially
Equivalent | | Performance | Meets ASTM D3577-09e | Meets ASTM D3577-09e | Substantially
Equivalent | | Dimensions and
Physical Properties | Meets ASTM D3577-09e | Meets ASTM D3577-09e | Substantially
Equivalent | | Tested for Use W/
Chemotherapy
Drugs | Meets ASTM D6978-05 | Meet ASTM D6978-05 | Substantially
Equivalent | | Biocompatibility | Meet ISO 10993-10; Dermal Sensitization and Primary
Skin Irritation Study | Meet ISO 10993-10; Dermal Sensitization and
Primary Skin Irritation Study | Substantially
Equivalent | | Labeling | Glove Pouch in Dispenser Box | Glove Pouch in Dispenser Box | Identical | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ 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 {11}------------------------------------------------ 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. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K150238](https://fda.innolitics.com/submissions/HO/subpart-e%E2%80%94surgical-devices/KGO/K150238) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com