(218 days)
Not Found
No
The summary describes a surgical glove and its physical and chemical properties. There is no mention of AI or ML technology.
No.
The device is a surgical glove intended to protect a surgical wound from contamination, not to treat or cure a disease or condition.
No
Explanation: The device is a surgical glove intended to protect a surgical wound from contamination and against chemotherapy drugs. It does not analyze patient data or provide medical diagnoses.
No
The device is a physical glove made of synthetic rubber, not software. The description focuses on material properties, physical performance, and chemical permeation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a surgical wound from contamination and for use with chemotherapy drugs. This is a protective barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and materials of the glove.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
- Performance Studies: The performance studies focus on biocompatibility, chemical permeation, and physical properties, which are relevant to a protective device, not a diagnostic one.
- No Mention of Diagnostic Metrics: There are no mentions of diagnostic metrics like sensitivity, specificity, AUC, etc.
In summary, the SensiCare PI surgeon's glove is a medical device intended for protection and barrier function, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The SensiCare PI surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemicals have been tested with these gloves.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 10.1 min. (10.1, 10.1) Cisplatin 1.0 mg/ml (1,000 ppm) 240 min. Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) 240 min. Cytarabine 100 mg/ml (100,000 ppm) 240 min. Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) 240 min. Doxorubicin Hydrochloride 2.0 mg/ml (2.000 ppm) 240 min. Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) 240 min. Fluorouracil 50.0 mg/ml (50,000 ppm) 240 min. Ifosfamide 50.0 mg/ml (50,000 ppm) 240 min. Methotrexate 25 mg/ml (25,000 ppm) 240 min. Mitomycin C 0.5 mg/ml (500 ppm) 240 min. Mitoxantrone 2.0 mg/ml (2,000 ppm) 240 min. Paclitaxel (Taxol) 6.0 mg/ml (6.000 ppm) 240 min. Thiotepa 10.0 mg/ml (10,000 ppm) 11.6 min. (20.2, 21.5, 11.6) Vincristine Sulfate 1.0 mg/ml (1,000 ppm) 240 min.
Please note that the following drugs have extremely low permeation time of less than 30 minutes: Carmustine (3.3 mg/ ml) has a minimum breakthrough time of 10.1 minutes; Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 11.6 minutes.
Product codes
KGO, LZC
Device Description
The SensiCare PI Surgical Gloves are disposable powder-free surgical gloves that are intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination. The gloves are made with polyisoprene and are cream in color. The SensiCare PI Surgical Gloves are available in a smooth grip and are constructed with a beaded cuff. The gloves have been tested for use with chemotherapy drugs per ASTM D6978.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance Testing (Bench)
Permeation testing was conducted on the SensiCare PI Surgical Glove per ASTM D6978-05, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The gloves were tested against fifteen chemotherapy drugs.
Physical performance qualities were evaluated per ASTM D3577, Standard Specification for Rubber Surgical Gloves.
Summary of Clinical Testing
This section does not apply. No clinical testing was performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2016
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist One Medline Place Mundelein, Illinois 60060
Re: K152428
Trade/Device Name: SensiCare PI Surgical Gloves Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO, LZC Dated: March 3, 2016 Received: March 4, 2016
Dear Jennifer Mason:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152428
Device Name SensiCare PI Surgical Gloves
Indications for Use (Describe)
The SensiCare PI surgeon's glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemicals have been tested with these gloves.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 10.1 min. (10.1, 10.1) Cisplatin 1.0 mg/ml (1,000 ppm) 240 min. Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) 240 min. Cytarabine 100 mg/ml (100,000 ppm) 240 min. Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) 240 min. Doxorubicin Hydrochloride 2.0 mg/ml (2.000 ppm) 240 min. Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) 240 min. Fluorouracil 50.0 mg/ml (50,000 ppm) 240 min. Ifosfamide 50.0 mg/ml (50,000 ppm) 240 min. Methotrexate 25 mg/ml (25,000 ppm) 240 min. Mitomycin C 0.5 mg/ml (500 ppm) 240 min. Mitoxantrone 2.0 mg/ml (2,000 ppm) 240 min. Paclitaxel (Taxol) 6.0 mg/ml (6.000 ppm) 240 min. Thiotepa 10.0 mg/ml (10,000 ppm) 11.6 min. (20.2, 21.5, 11.6) Vincristine Sulfate 1.0 mg/ml (1,000 ppm) 240 min.
Please note that the following drugs have extremely low permeation time of less than 30 minutes: Carmustine (3.3 mg/ ml) has a minimum breakthrough time of 10.1 minutes; Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 11.6 minutes.
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.
3
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4
Image /page/4/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 starburst symbol. The starburst is white and appears to be composed of four elongated triangles converging at a central point. A gray bar is visible on the right edge of the image.
SECTION 5 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060
Registration Number: 1417592
Contact Person
Jennifer Mason Senior Regulatory Affairs Specialist Phone: 847-643-3652 Email: jamason@medline.com
Summary Preparation Date March 31, 2016
Type of 510(k) Submission Traditional
Device Name / Classification
Name of Device: SensiCare PI Surgical Gloves Proprietary Name: SensiCare PI Surgical Gloves Common Name: Surgeon's gloves Classification Name: Surgeon's gloves Product Code: KGO, LZC Regulatory Class: Class I Regulation #: 21 CFR 878.4460 Classification Panel: General Hospital
Predicate Device
Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drugs K110272
Device Description
The SensiCare PI Surgical Gloves are disposable powder-free surgical gloves that are intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination. The gloves are made with
CONFIDENTIAL
5
Image /page/5/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in white, block letters, stacked on top of a white star-like symbol. The star symbol has four points, with the top and bottom points being longer than the side points. There is a gray rectangle in the upper right corner of the image.
polyisoprene and are cream in color. The SensiCare PI Surgical Gloves are available in a smooth grip and are constructed with a beaded cuff. The gloves have been tested for use with chemotherapy drugs per ASTM D6978.
Indications for Use:
The SensiCare PI surgeon's glove is a disposable device made of synthetic rubber intended to be worn by onerating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemicals have been tested with these gloves.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 10.1 min. (10.1, 10.1, 10.1) |
|---|---|
| Cisplatin 1.0 mg/ml (1,000 ppm) | 240 min. |
| Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) | 240 min. |
| Cytarabine 100 mg/ml (100,000 ppm) | 240 min. |
| Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) | 240 min. |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | 240 min. |
| Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) | 240 min. |
| Fluorouracil 50.0 mg/ml (50,000 ppm) | 240 min. |
| Ifosfamide 50.0 mg/ml (50,000 ppm) | 240 min. |
| Methotrexate 25 mg/ml (25,000 ppm) | 240 min. |
| Mitomycin C 0.5 mg/ml (500 ppm) | 240 min. |
| Mitoxantrone 2.0 mg/ml (2,000 ppm) | 240 min. |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | 240 min. |
| Thiotepa 10.0 mg/ml (10,000 ppm) | 11.6 min. (20.2, 21.5, 11.6) |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | 240 min. |
Please note that the following drugs have extremely low permeation time of less than 30 minutes: Carmustine (3.3 mg/ml) has a minimum breakthrough time of 10.1 minutes; Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 11.6 minutes.
Summary of Technological Characteristics
The SensiCare PI Surgical Glove is substantially equivalent to the predicate, K110272, Sterile Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs. Both gloves have intended use, same material and the same device performance.
6
Image /page/6/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked vertically, and to the left of a white star-like symbol with four points. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a distinctive symbol.
TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
| Device
Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Product Name | SensiCare PI Surgical Gloves | Sterile Polyisoprene Powder-
Free Surgical Gloves Tested for
Use with Chemotherapy Drugs | N/A |
| 510(k) Reference | | K110272 | N/A |
| Product Owner | Medline Industries, Inc. | Cardinal Health | Different |
| Product Code | KGO | KGO | Substantially
Equivalent |
| Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Substantially
Equivalent |
| Intended Use | The SensiCare PI surgeon's
glove is a disposable device
made of synthetic rubber
intended to be worn by operating
room personnel to protect a
surgical wound from
contamination. In addition, these
gloves were tested for use with
chemotherapy drugs in
accordance with ASTM D6978
Standard Practice for Assessment
of Medical Gloves to Permeation
by Chemotherapy Drugs.
Warning: Do not use with
Carmustine and Thiotepa | This powder-free surgeon's
glove is a disposable device
made of synthetic rubber
intended to be worn by operating
room personnel to protect a
surgical wound from
contamination. In addition, these
gloves were tested for use with
chemotherapy drugs in
accordance with ASTM D 6978
Standard Practice for Assessment
of Medical Gloves to Permeation
by Chemotherapy Drugs. | Substantially
Equivalent |
| Sizes | 5 ½ , 6, 6 ½ , 7, 7 ½ , 8, 8 ½, 9 | 5 ½ , 6, 6 ½ , 7, 7 ½ , 8, 8 ½, 9 | Substantially
Equivalent |
| Materials | Polyisoprene | Polyisoprene | Substantially
Equivalent |
| Colorant | Yes - cream colored. Contains a
blend of three colorants
(naphthos AS red, azo yellow
and carbon black) | Yes - cream colored | Substantially
Equivalent |
| Dimensions -
Length | Meets ASTM D 3577
270mm min. | Meets ASTM D 3577
270mm min. | Substantially
Equivalent |
| Dimensions - Width | Meets ASTM D 3577
5 ½ - 70±6mm
6 - 76±6mm
6 ½ - 83±6mm
7 - 89±6mm
7 ½ - 95±6mm | Meets ASTM D 3577
5 ½ - 70±6mm
6 - 76±6mm
6 ½ - 83±6mm
7 - 89±6mm
7 ½ - 95±6mm | Substantially
Equivalent |
| | 8 - 102±6mm | 8 - 102±6mm | |
| | 8 ½ - 108±6mm | 8 ½ - 108±6mm | |
| | 9 - 114±6mm | 9 - 114±6mm | |
| Dimensions –
Finger Thickness | Meets ASTM D3577
0.10mm min | Meets ASTM D3577
0.10mm min | Substantially
Equivalent |
| Dimensions – Palm
Thickness | Meets ASTM D3577
0.10mm min | Meets ASTM D3577
0.10mm min | Substantially
Equivalent |
| Dimension – Cuff
Thickness | Meets ASTM D3577
0.10mm min | Meets ASTM D3577
0.10mm min | Substantially
Equivalent |
| Physical Properties | Meets ASTM D3577
Before Aging
Tensile Strength - 17 MPa min
Ultimate Elongation – 650% min
Stress at 500% Elongation – 7.0
MPa min | Meets ASTM D3577
Before Aging
Tensile Strength - 17 MPa min
Ultimate Elongation – 650% min
Stress at 500% Elongation –
7MPa min | Substantially
Equivalent |
| | Meets ASTM 3577
After Aging
Tensile Strength – 12 MPa min
Ultimate Elongation - 490% min | Meets ASTM 3577
After Aging
Tensile Strength – 12 MPa min
Ultimate Elongation – 490% min | Substantially
Equivalent |
| Freedom from
Holes | Meets 21 CFR 800.20 and
ASTM D3577 when tested in
accordance with ASTM D5151
Inspection Level 1, AQL 1.5 | Meets 21 CFR 800.20 and
ASTM D3577 when tested in
accordance with ASTM D5151
Inspection Level 1, AQL 1.5 | Substantially
Equivalent |
| Powder or Powder-free | Powder-free | Powder-free | Substantially
Equivalent |
| Residual Powder | 240
Busulfan (6mg/ml) >240
Carmustine (3.3mg/ml) 0.37
Cisplatin (1.0mg/ml) >240
Cytarabine (100mg/ml) >240
Cyclophosphamide (20mg/ml)
240
Dacarbazine (10mg ml) >240
Doxorubicin (2.0mg ml) >240
Ellence (25mg/ml) >240
Etoposide (20mg/ml) >
Fludarabine (25mg.ml) >240
Fluorouracil (50mg ml) >240 | Similar |
| | Carmustine 10.1 | | |
| | Cisplatin >240 | | |
| | Cytarabine >240 | | |
| | Cyclophosphamide >240 | | |
| | Dacarbazine >240 | | |
| | Doxorubicin >240 | | |
| | Etoposide >240 | | |
| | Fluorouracil >240 | | |
| Ifosfamide >240 | Idarubicin (1mg/ml) >240 | | |
| | Ifosfamide (50mg/ml) >240 | | |
| | Mechlorethamine HCI (1mg.ml) >240 | | |
| Methotrexate >240 | Melphalan (5mg.ml) >240 | | |
| Mitoxantrone >240 | Methotrexate (25 mg.ml) >240 | | |
| Mitomycin C >240 | Mitoxantrone (2mg.ml) >240 | | |
| Paclitaxel >240 | Mitomycin C (0.5mg.ml) >240 | | |
| | Paclitaxel (6.0 mg/ml) >240 | | |
| | Paraplatin (10mg.ml) >240 | | |
| | Rituximab (10mg/ml) >240 | | |
| Thiotepa 11.6 | Thiotepa (10mg/ml) 0.44 | | |
| | Trisenox (0.1mg.ml) >240 | | |
| Vincristine sulfate >240 | Vincristine sulfate (1mg/ml) >240 | | |
| Sterile or Non-sterile | Sterile | Sterile | Substantially Equivalent |
| Sterilization Method | Gamma 10-6 | Gamma | Substantially Equivalent |
| Primary Skin Irritation | Under the conditions of the study (per ISO 10993-10), the device is not an irritant | Meets ISO 10993-10 | Substantially Equivalent |
| Sensitization (Guinea Pig Maximization Test) | Under the conditions of the study (per ISO 10993-10), the device is not a sensitizer | Meets ISO 10993-10 | Substantially Equivalent |
| Elements Contained on Product Labeling | | | |
| • Product Identifier | Yes | Yes | Substantially Equivalent |
| • Material | Yes | Yes | Substantially Equivalent |
| • Product Characteristics | Yes | Yes | Substantially Equivalent |
| • Size | Yes | Yes | Substantially Equivalent |
| • Manufacturer Name and Address | Yes | Yes | Substantially Equivalent |
| • Single Use Only | Yes | Yes | Substantially Equivalent |
| • In Pairs, Left/Right | Yes | Yes | Substantially Equivalent |
| • Country of
Manufacturing | Yes | Yes | Substantially
Equivalent |
| • List of
Chemotherapy
Drugs and
Breakthrough
Times | Yes | Yes | Substantially
Equivalent |
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Image /page/7/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized star-like symbol. The star is white and has four points, with the top and bottom points being longer than the side points. The overall design is clean and corporate, suggesting a professional and reliable brand identity.
8
Image /page/8/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, sans-serif font, placed diagonally across a blue square. A white, stylized starburst shape is behind the text, with its points extending beyond the edges of the square. The overall design is clean and modern.
9
Image /page/9/Picture/0 description: The image features the Medline logo, which is set against a blue background. The logo consists of the word "MEDLINE" in a sans-serif font, positioned to the left of a stylized white symbol that resembles a star or a compass. The symbol is vertically oriented, with its pointed ends extending upwards and downwards. The overall design is clean and professional, conveying a sense of reliability and expertise.
Summary of Non-Clinical Testing
The biocompatibility evaluation for the SensiCare PI Surgical Glove was conducted in accordance with ANSI/AAMI/ISO 10993-1:2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. The SensiCare PI Surgical Gloves are classified as a surface contacting device with a limited contact duration of less than 24 hours.
The following tests were performed to evaluate the biocompatibility of the SensiCare PI Surgical Gloves:
- ISO 10993-10: Irritation Intracutaneous reactivity ●
- . ISO 10993-10: Delayed-Type Hypersensitivity (Sensitization) - Guinea Pig Maximization Test
Performance Testing (Bench)
Permeation testing was conducted on the SensiCare PI Surgical Glove per ASTM D6978-05, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. The gloves were tested against fifteen chemotherapy drugs.
Physical performance qualities were evaluated per ASTM D3577, Standard Specification for Rubber Surgical Gloves.
Summary of Clinical Testing
This section does not apply. No clinical testing was performed.
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the SensiCare PI Surgical Glove is as safe and as effective and performs as well as the predicate, Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drugs (K110272). Therefore, the SensiCare PI Surgical Glove is substantially equivalent to the predicate.