(206 days)
Not Found
No
The 510(k) summary describes a standard surgical glove and its physical and chemical resistance properties. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
The device is a surgeon's glove, intended to protect a surgical wound from contamination and protect operating room personnel. It does not directly treat or diagnose a disease or condition.
No
This device, a surgeon's glove, is intended for protection from contamination, not for diagnosing medical conditions or diseases. Its use involves preventing contact with chemotherapy drugs, not detecting or assessing health states.
No
The device description clearly states it is a "Powder Free Nitrile Surgical Glove" made from "synthetic rubber latex," which is a physical hardware product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body ("in vitro").
- Intended Use: The intended use of this device is clearly stated as "to be worn by operating room personnel to protect a surgical wound from contamination." This is a barrier device used during a surgical procedure, not a device used to perform diagnostic tests on patient samples.
- Device Description: The description details the physical properties and materials of a surgical glove, not components or reagents used for diagnostic testing.
- Performance Studies and Key Metrics: The performance studies and key metrics focus on the physical integrity, barrier properties (especially against chemotherapy drugs), and biocompatibility of the glove. These are relevant to a protective barrier device, not an IVD.
The testing for chemotherapy drug permeation is a safety and performance characteristic of the glove as a barrier, not a diagnostic test.
N/A
Intended Use / Indications for Use
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Product codes
KGO, LZC
Device Description
Powder Free Nitrile Surgical Glove, Sterile meets all the requirements of ASTM standard D3577-09, D6978-05 and FDA 21 CFR 878.4460.
The powder free nitrile surgical glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is hand specific. The physical properties of glove i.e. tensile strength meet ASTM standard D3577-09.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was tested for:
- Dimensions (Length, Width, Thickness - Finger, Palm, Cuff) according to ASTM D3577-09. Results: Meets.
- Physical Properties Before Aging (Tensile Strength, Ultimate Elongation, Stress at 500% Elongation) according to ASTM D3577-09. Results: Meets 7MPa min, 650% min, 7.0MPa min respectively.
- Physical Properties After Aging (Tensile Strength, Ultimate Elongation) according to ASTM D3577-09. Results: Meets 12MPa min, 490% min respectively.
- Watertight (1000ml) according to ASTM D5151-06. Results: Meets 21CFR 800.20 & ASTM D3577 requirements of AQL 1.5.
- Powder Free according to ASTM D6124-06 (≤ 2 mg/glove). Results: Meets requirements of ≤2.0 mg/glove for Powder-Free designation per ASTM D3577.
- Chemotherapy Drug Permeation Test according to ASTM D6978-05. Results:
- Carmustine (BCNU) 3.3mg/ml: 30.4 minutes
- Cisplatin 1.0mg/ml: > 240 minutes
- Cyclophosphamide (Cytoxan) 20.0mg/ml: > 240 minutes
- Dacarbazine 10.0mg/ml: > 240 minutes
- Doxorubicin Hydrochloride 2.0mg/ml: > 240 minutes
- Etoposide (Toposar) 20.0mg/ml: > 240 minutes
- Fluorouracil 50.0mg/ml: > 240 minutes
- Ifosfamide 50.0mg/ml: > 240 minutes
- Mitoxantrone 2.0mg/ml: > 240 minutes
- Paclitaxel (Taxol) 6.0mg/ml: > 240 minutes
- Thiotepa 10.0mg/ml: 59.0 minutes
- Vincristine Sulfate 1.0mg/ml: > 240 minutes
CAUTION: Testing showed an average breakthrough time of 30.4 minutes for Carmustine and an average breakthrough time of 59.0 minutes for Thiotepa.
- Biocompatibility (Primary Skin Irritation) according to ISO 10993-10:2010(E) & Consumer Product Safety Commission, Tittle 16, Chapter II, Part 1500. Results: Passes, Not a primary skin irritant under the conditions of the study.
- Biocompatibility (Dermal Sensitization) according to ISO 10993-10:2010(E) & Consumer Product Safety Commission, Tittle 16, Chapter II, Part 1500.3(c)(4). Results: Passes, Not a contact sensitizer under the conditions of the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2017
WRP Asia Pacific Sdn Bhd Sarala Jayaraman Regulatory Affairs Manager Lot 1, Jalan 3, Kaw Perusahaan Bandar Baru Salak Tinggi Sepang, 43900 MY
Re: K161823
Trade/Device Name: Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: Class I Product Code: KGO, LZC
Dated: December 15, 2016
Received: December 19, 2016
Dear Sarala Jayaraman:
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.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K161823
Device Name
Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs
Indications for Use (Describe)
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| *Carmustine (BCNU) | 3.3mg/ml | 30.4 |
| Cisplatin | 1.0mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 |
| Dacarbazine | 10.0mg/ml | > 240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 |
| Mitoxantrone | 2.0mg/ml | > 240 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 |
| *Thiotepa | 10.0mg/ml | 59.0 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |
CAUTION: Testing showed an average breakthrough time of 30.4 minutes for Carmustine and an average breakthrough time of 59.0 minutes for Thiotepa.
Type of Use (Select one or both, as applicable)
[] Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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:
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"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."
4
1.0 Submitter:
| Name: | Sarala Devi Jayaraman |
|---|---|
| Address: | WRP Asia Pacific Sdn Bhd |
| Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, | |
| 43900 Sepang, Selangor Darul Ehsan, MALAYSIA | |
| Phone No.: | +60 3 8706 1486 |
| Fax No.: | +60 3 8706 1485 |
Date of Summary Prepared: 12 January 2017
2.0 Name of the modified device Identification:
Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs 510(k) Number: K161823 Common Name: Surgical Gloves Classification Name: Surgeon's Gloves (21 CFR 878.4460 product code KGO) Patient Examination Gloves Specialty (21 CFR 880.6250 product code LZC)
3.0 Identification of The Legally Marketed Devices that equivalency is claimed:
| Predicate 1 | Predicate 2 | |
|---|---|---|
| Manufacturer | Cardinal Health | |
| 200, LLC | Medline | |
| Industries, | ||
| Incorporated | ||
| Device name | Cardinal Health™ | |
| Sterile Neoprene | ||
| Powder-free | ||
| Surgical Gloves | ||
| with Nitrile | ||
| Coating and | ||
| Tested for Use | ||
| with | ||
| Chemotherapy | ||
| Drugs | ||
| (Yellow) | SensiCare PI | |
| Surgical Gloves | ||
| 510(k) Number | K153316 | K152428 |
| Regulatory Class | I | I |
| Product Code | KGO, LZC | KGO, LZC |
4.0 Description of The Device:
Powder Free Nitrile Surgical Glove, Sterile meets all the requirements of ASTM standard D3577-09, D6978-05 and FDA 21 CFR 878.4460.
The powder free nitrile surgical glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is hand specific. The physical properties of glove i.e. tensile strength meet ASTM standard D3577-09.
5
5.0 Intended Use of the Device:
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has also been tested for use with chemotherapy drugs.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug Permeation | ||
|---|---|---|
| The following chemicals have been tested with these gloves. | ||
| Chemotherapy Drug | Concentration | Breakthrough Detection |
| Time in Minutes | ||
| *Carmustine (BCNU) | 3.3mg/ml | 30.4 |
| Cisplatin | 1.0mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 |
| Dacarbazine | 10.0mg/ml | > 240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 |
| Mitoxantrone | 2.0mg/ml | > 240 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 |
| *Thiotepa | 10.0mg/ml | 59.0 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |
CAUTION: Testing showed an average breakthrough time of 30.4 minutes for Carmustine and an average breakthrough time of 59.0 minutes for Thiotepa.
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Nitrile Surgical Glove, Sterile are summarized with the following technological characteristics compared to ASTM D3577 or equivalent standards as shown in Table 1
Compliant to chemotherapy claim whereby glove thickness and length meets minimal thickness of 0.10 mm and minimal length of 270 respectively.
6
Table 1
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | ||
|---|---|---|---|---|
| Predicate 1 | Predicate 2 | Current | ||
| Manufacturer(s) | Cardinal Health | |||
| 200, LLC | Medline Industries, | |||
| Incorporated | WRP Asia Pacific | |||
| Sdn Bhd | ||||
| 510(k) Number | K153316 | K152428 | K161823 | |
| Intended use | - | A powder-free | ||
| sterile 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 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 | A powder-free | |||
| sterile 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. | ||||
| *CAUTION: Testing | ||||
| showed an average | ||||
| breakthrough time | ||||
| of 30.4 minutes for | ||||
| Carmustine and an | ||||
| average | ||||
| breakthrough time | ||||
| of 59.0 minutes for | ||||
| Thiotepa. | ||||
| Material | ASTM D3577- | |||
| 09 | Synthetic Neoprene | |||
| Polymer coated with | ||||
| Nitrile | Synthetic | |||
| Polyisoprene | Nitrile | |||
| Color | - | Yellow | Cream colored. | |
| Contains a | ||||
| blend of three | ||||
| colorants | ||||
| (naphthos AS red, azo | ||||
| yellow and carbon | ||||
| black) | Natural | |||
| Texture | - | Micro roughened | ||
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | ||
| 510(k) Number | ASTM D3577-09 | Predicate 1 | ||
| K153316 | Predicate 2 | |||
| K152428 | Current | |||
| K161823 | ||||
| Dimensions | ASTM D3577-09 | Meets | Meets | Meets |
| Length | ASTM D3577-09 | Min 270mm | Min 270mm | Min 270mm |
| Width | ASTM D3577-09 | Meets | Meets | |
| 5 ½ : 70±6mm | ||||
| 6 : 76±6mm | ||||
| 6 ½ : 83±6mm | ||||
| 7 : 89±6mm | ||||
| 7 ½ : 95±6mm | ||||
| 8 : 102±6mm | ||||
| 8 ½ : 108±6mm | ||||
| 9 : 114±6mm | Meets | |||
| 5 ½ : 70±6mm | ||||
| 6 : 76±6mm | ||||
| 6 ½ : 83±6mm | ||||
| 7 : 89±6mm | ||||
| 7 ½ : 95±6mm | ||||
| 8 : 102±6mm | ||||
| 8 ½ : 108±6mm | ||||
| 9 : 114±6mm | ||||
| Thickness |
- Finger
- Palm
- Cuff | ASTM D3577-09 | Meets | Meets
Min 0.10mm
Min 0.10mm
Min 0.10mm | Meets
Min 0.10mm
Min 0.10mm
Min 0.10mm |
| Physical Properties
Before Aging
Tensile Strength :
Ultimate
Elongation :
Stress at 500%
Elongation : | ASTM D3577-09 | Meets | Meets
7MPa min
650% min
7.0MPa min | Meets
7MPa min
650% min
7.0MPa min |
| Physical Properties
After Aging
Tensile Strength :
Ultimate
Elongation : | ASTM D3577-09 | Meets | Meets
12MPa min
490% min | Meets
12MPa min
490% min |
| Watertight
(1000ml) | ASTM D5151-06 | Meets 21CFR
800.20 & ASTM
D3577
requirements of
AQL 1.5 | 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 |
| Powder Free | ASTM D6124-06
(≤ 2 mg/glove) | Meets
requirements of
≤2.0 mg/glove
for Powder-Free
designation per
ASTM D3577 | 240 | > 240 | > 240 |
| Cytarabine | 100.0mg/ml | | > 240 | - |
| Cyclophosphamide
(Cytoxan) | 20.0mg/ml | > 240 | > 240 | > 240 |
| Dacarbazine | 10.0mg/ml | - | > 240 | > 240 |
| Doxorubicin
Hydrochloride | 2.0mg/ml | > 240 | > 240 | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 | > 240 | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 | > 240 | > 240 |
| Ifosfamide | 50.0mg/ml | - | > 240 | > 240 |
| Methotrexate | 25.0mg/ml | > 240 | > 240 | - |
| Mitoxantrone | 2.0mg/ml | - | > 240 | > 240 |
| Mitomycin C | 0.5mg/ml | > 240 | > 240 | - |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 | > 240 | > 240 |
| *Thiotepa | 10.0mg/ml | 110.5 | 11.6 | 59.0 |
| Vincristine Sulfate | 1.0mg/ml | > 240 | > 240 | > 240 |
| Warning Statement | | Under the test
conditions
prescribed by the
test, the
minimum
normalized
breakthrough
detection times
for each of the 11
chemotherapy
drugs tested
exceeded the
maximum
testing time of
240 minutes
except for
Carmustine
(BCNU) (3.3
mg/ml), which
showed
permeation time
of
60.1 minutes, and
Thiotepa
(10 mg/ml), which
showed
permeation time
of 110.5
minutes. | 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. | CAUTION: Testing
showed an
average
breakthrough time
of 30.4 minutes
for Carmustine
and an average
breakthrough time
of 59.0 minutes
for Thiotepa. |
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | | |
| | | Predicate 1 | Predicate 2 | Current |
| 510(k) Number | | K153316 | K152428 | K161823 |
| Biocompatibility | Primary Skin
Irritation -
ISO 10993-
10:2010(E) &
Consumer Product
Safety Commission,
Tittle 16, Chapter
II, Part 1500 | Non-Irritating,
under the
conditions of
the study | Under the
conditions of the
study
(per ISO 10993-
10), the device is
not an irritant | Passes
Not a primary
skin irritant
under the
conditions of the
study. |
| Biocompatibility | Dermal
Sensitization -
ISO 10993-
10:2010(E) &
Consumer Product
Safety Commission,
Tittle 16, Chapter
II, Part
1500.3(c)(4) | Non-sensitizing,
under the
conditions of
the study | Under the
conditions of the
study
(per ISO 10993-
10), the device is
not a sensitizer | Passes
Not a contact
sensitizer under
the conditions of
the study. |
| Size | Medical Glove
Guidance Manual -
Labeling | - | 5½
6.0
6½
7.0
7½
8.0
8½
9.0 | 5½
6.0
6½
7.0
7½
8.0
8½
9.0 |
| Single Use | Medical Glove
Guidance Manual -
Labeling | Single use | Single use | Single use |
| Sterility Status | Medical Glove
Guidance Manual -
Labeling | Sterile | Sterile | Sterile |
7
8
9
10
7.0 Substantial Equivalence Based on Assessment of Non-Clinical Performance Data
The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements).
The device and the predicates share the same intended use, same material, same specifications for thickness and length, similar labeling according to the glove guidance, and same compliance with standards for physical properties, powder free, biocompatibility and water tightness. Thus, the device is substantially equivalent to the predicates.
Current device compliant to chemotherapy claim whereby glove thickness and length meets minimal thickness of 0.10 mm and minimal length of 270 respectively.
Substantial Equivalent Based on Assessment of Clinical Performance Data 8.0
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
9.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the leqally marketed predicate devices.