(298 days)
No
The document describes a surgical glove and its physical properties and testing against standards. There is no mention of AI or ML technology.
No.
This device is a surgical glove intended for protection against contamination, not for treating a disease or condition.
No
The device is a surgical glove intended to protect a surgical wound from contamination and is tested for use with chemotherapy drugs, not for diagnosing conditions.
No
The device description clearly states it is a physical glove made of synthetic rubber latex, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "surgeon's glove... intended to be worn by surgeons and /or operating room personnel to protect a surgical wound from contamination". This is a barrier device for protection, not a device used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description reinforces its function as a protective glove made of synthetic rubber latex.
- Performance Studies: The performance studies focus on physical properties, freedom from holes, powder residues, biocompatibility (skin irritation and sensitization), and permeation by chemotherapy drugs. These are all relevant to the protective barrier function and safety of the glove, not to diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The testing for use with chemotherapy drugs is a safety feature related to the glove's barrier function when handling these substances, not a diagnostic test itself.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
KGO
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 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 (
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo 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)
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)
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 (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.