(236 days)
Not Found
No
The document describes a physical barrier device (examination gloves) and its performance against chemotherapy drugs. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a glove intended to prevent contamination between patient and examiner, not to treat a medical condition.
No
The device is a disposable medical glove intended to prevent contamination between a patient and an examiner, acting as a barrier rather than providing diagnostic information.
No
The device is a physical examination glove made of nitrile, not a software program. The description focuses on material properties and barrier protection.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner." This describes a barrier device for personal protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties of the glove (material, color, powder-free, non-sterile) and its function as a barrier.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information. The testing performed relates to the glove's barrier properties against chemotherapy drugs and its biocompatibility, which are relevant for a protective medical device.
Therefore, this device falls under the category of a medical device, specifically a patient examination glove, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
Test Chemotherapy Drug Name and Concentration
- · Carmustine (BCNU) (3.3mg/ml),(3.300 ppm) Minimum Breakthrough Detection Time 5.4 Minutes
- · Cisplatin(1.0mg/ml), (1,000 ppm) Minimum Breakthrough Detection Time >240 Minutes
- · Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm) Minimum Breakthrough Detection Time >240 Minutes
- · Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) Minimum Breakthrough Detection Time >240 Minutes
- · Doxorubicin HCL(2mg/ml),(2,000 ppm) Minimum Breakthrough Detection Time >240 Minutes
- · Etoposide /Toposar (20mg/ml), (20,000 ppm) Minimum Breakthrough Detection Time >240 Minutes
- · Fluorouracil(50mg/ml), (50,000 ppm) Minimum Breakthrough Detection Time >240 Minutes
- · Ifosfamide (50mg/ml), (50,000 ppm) Minimum Breakthrough Detection Time >240 Minutes
- · Mitoxantrone(2mg/ml),(2,000 ppm) Minimum Breakthrough Detection Time >240 Minutes
- · Paclitaxel/Taxol(6.0mg/ml),(6.000 ppm) Minimum Breakthrough Detection Time >240 Minutes
- · Thiotepa (10mg/ml),(10,000 ppm) Minimum Breakthrough Detection Time 40.4 Minutes
- · Vincristine Sulfate(1.0mg/ml),(1,000 ppm) Minimum Breakthrough Detection Time >240 Minutes
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) 5.4 minutes and Thiotepa 40.4 minutes.
Product codes
LZA, LZC
Device Description
The subject device in this 510(k) Notification is a Sterling/Grey Nitrile Examination gloves, with claims and tested for use with Chemotherapy drugs.
The subject device is a patient examination glove made from nitrile compound, Sterling or Grev in color, powder free and non sterile (as per 21 CFR 880.6250, class I).
The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
This device is manufactured in facilities compliant to ISO 9001:2008 certified in Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination, Surgical and Industrial Gloves & Nitrile Sheath
The device is manufactured to comply with ISO 13485:2003 / EN ISO 13485:2012 Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination & Sterile Surgical Gloves
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purpose)
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)
Testing was performed per ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010 and 16 CFR Part 1500.41.
Biocompatibility tests indicated that under the conditions of the studies, the gloves were nonsensitizing, non-irritating, and non-systemically toxic.
Chemotherapy Drug Permeation Test results for the subject device:
- Carmustine (BCNU): 5.4 minutes
- Cisplatin: >240 minutes
- Cyclophosphamide/Cytoxan: >240 minutes
- Dacarbazine(DTIC): >240 minutes
- Doxorubicin HCL: >240 minutes
- Fluorouracil: >240 minutes
- Ifosfamide: >240 minutes
- Mitoxantrone: >240 minutes
- Paclitaxel/Taxol: >240 minutes
- Thiotepa: 40.4 minutes
- Vincristine Sulfate: >240 minutes
The subject device tested to a more stringent criteria for freedom from pinholes (G2 AQL 1.0) compared to the predicate device (G1 AQL 1.5).
The subject device was tested for Acute Systemic Toxicity and no mortality or evidence of Systemic Toxicity was observed, whereas the predicate device was not tested for Systemic Toxicity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Biocompatibility: nonsensitizing, non-irritating, and non-systemically toxic.
Freedom from pinholes testing: Pass quality level at G2 AQL 1.0 (tested in accordance with ASTM D5151 test method).
Powder Free Residue:
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2016
Brightway Holdings Sdn Bhd G. Baskaran Group Managing Director Lot 1559, Jalan Istimewa, Batu Belah Klang, 42100 MY
Re: K161215
Trade/Device Name: Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: November 16, 2016 Received: November 21, 2016
Dear G. Baskaran:
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,
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
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161215
Device Name
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS
Indications for Use (Describe)
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
Test Chemotherapy Drug Name and Concentration
- · Carmustine (BCNU) (3.3mg/ml),(3.300 ppm)
- · Cisplatin(1.0mg/ml), (1,000 ppm)
- · Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm)
- · Dacarbazine(DTIC) 10mg/ml, (10,000 ppm)
- · Doxorubicin HCL(2mg/ml),(2,000 ppm)
- · Etoposide /Toposar (20mg/ml), (20,000 ppm)
- · Fluorouracil(50mg/ml), (50,000 ppm)
- · Ifosfamide (50mg/ml), (50,000 ppm)
- · Mitoxantrone(2mg/ml),(2,000 ppm)
- · Paclitaxel/Taxol(6.0mg/ml),(6.000 ppm)
- · Thiotepa (10mg/ml),(10,000 ppm)
- · Vincristine Sulfate(1.0mg/ml),(1,000 ppm)
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) 5.4 minutes and Thiotepa 40.4 minutes.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Minimum Breakthrough Detection Time
5.4 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
240 Minutes
40.4 Minutes
240 Minutes
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."
FORM FDA 3881 (8/14)
3
510(K) SUMMARY
K161215
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS
-
- Submitter :
| Company Name : | BRIGHTWAY HOLDINGS SDN. BHD. |
|---|---|
| Street Address: | Lot 1559, Jalan Istimewa, |
| Batu Belah, 42100 Klang | |
| Selangor Darul Ehsan. | |
| Country: | Malaysia |
| Phone No. : | 603-3343 1007 & 603-3343 1094. |
| Fax No. : | 603-3341 4800 |
| E-mail Address : | brightway@brightway919.com |
| Contact Person : | Mr. G. Baskaran (Group Managing Director) |
| baskar@brightway919.com | |
| Mr. Felix Darrel (Group Marketing Manager) | |
| felix.marketing@brightway919.com |
- 30th November 2016 2. Preparation Date :
-
- Name of the Device :
Device trade or proprietary name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS
4
Device Classification Name: Polymer Patient Examination Glove (21 CFR 88.6250)
Device common or usual name: NITRILE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPHY DRUGS
FDA Device Class: Class 1
Product Code: LZA, LZC
4. Identification of the Device :
Class I patient Examination glove and tested for use with Chemotherapy Drugs, Powder Free, LZC, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.
5. Device Description:
The subject device in this 510(k) Notification is a Sterling/Grey Nitrile Examination gloves, with claims and tested for use with Chemotherapy drugs.
The subject device is a patient examination glove made from nitrile compound, Sterling or Grev in color, powder free and non sterile (as per 21 CFR 880.6250, class I).
The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
This device is manufactured in facilities compliant to ISO 9001:2008 certified in Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination, Surgical and Industrial Gloves & Nitrile Sheath
The device is manufactured to comply with ISO 13485:2003 / EN ISO 13485:2012 Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination & Sterile Surgical Gloves
5
6. Intended use of the Device
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Test Chemotherapy Drug Name and Concentration | Minimum Breakthrough Detection Time |
|---|---|
| • Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) | 5.4 Minutes |
| • Cisplatin(1.0mg/ml), (1,000 ppm) | >240 Minutes |
| • Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm) | >240 Minutes |
| • Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) | >240 Minutes |
| • Doxorubicin HCL(2mg/ml),(2,000 ppm) | >240 Minutes |
| • Etoposide /Toposar (20mg/ml), (20,000 ppm) | >240 Minutes |
| • Fluorouracil (50mg/ml), (50,000 ppm) | >240 Minutes |
| • Ifosfamide (50mg/ml), (50,000 ppm) | >240 Minutes |
| • Mitoxantrone(2mg/ml),(2,000 ppm) | >240 Minutes |
| • Paclitaxel/Taxol(6.0mg/ml),(6,000 ppm) | >240 Minutes |
| • Thiotepa (10mg/ml),(10,000 ppm) | 40.4 Minutes |
| • Vincristine Sulfate(1.0mg/ml),(1,000 ppm) | >240 Minutes |
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) 5.4 minutes and Thiotepa 40.4 minutes.
7. Substantial Equivalence Based on Assessment of Non-Clinical Performance Data
Testing was performed per ASTM D6319-10 , ASTM D5151-06, ASTM D6124- 06,ISO 10993-10:2010 and 16 CFR Part 1500.41.
Biocompatibility tests indicated that under the conditions of the studies, the gloves were nonsensitizing, non-irritating, and non-systemically toxic
6
8. Legally Marketed Device to which Substantial Equivalence is Claimed
The legally marketed predicate device in scope is as follows:
-
- K151750 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile
Substantial Equivalence Comparison Table:
The subject Device, K161215 - BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPHY CLAIM is substantially equivalent in safety and effectiveness to K151750 - Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile
The subject device and predicate device use a similar Nitrile barrier film to achieve a device for the intended use. The properties between the subject device and the predicate device are compared in the following table:
| Characteristics | Subject Device
K161215 | Predicate Device
K151750 | Comments |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sterling/Grey | Blue, White | |
| Manufacturer | Brightway Holdings Sdn Bhd | Kossan International Sdn Bhd | N/A |
| 510(K) Number | K161215 | K151750 | N/A |
| Identification | Nitrile Examination Gloves, Powder Free,Sterling/Grey Coloured, Tested For Use with Chemotherapy Drugs | 1. Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs
2. Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs | N/A |
| Device Classification Name/
Regulation Number | Patient Examination Glove/
21 CFR Part 880.6250 | Patient Examination Glove/
21 CFR Part 880.6250 | Same |
| Product Code | LZA, LZC | LZA, LZC | Same |
| | BRIGHTWAY BRAND
NITRILE EXAMINATION
GLOVES, POWDER FREE,
[STERLING/GREY] TESTED
FOR USE WITH
CHEMOTHERAPHY
DRUGS is a disposable
device intended for
medical purpose worn on
the examiner's hand or
finger to prevent
contamination between
patient and examiner. | A patient examination
glove is a disposable
device intended for
medical purposes that is
worn on the examiner's
hand to prevent
contamination between
patient and examiner.
These gloves were
tested for use with
chemotherapy drugs
per ASTM D6978-05
(Reapproved 2013)
Standard Practice for
Assessment of Medical
Gloves to Permeation
by Chemotherapy Drugs | |
| Intended Use | | Same | Same |
| Materials | Nitrile | Nitrile | Same |
| Color | Grey / Sterling | Blue, and White | The difference in
color does
not raise any
safety issues |
| Design | Meet Requirements of
ASTM D6319 | Extra Small
Small
Medium
Large
Extra Large
Double Extra Large | Same |
| Single Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Length | minimum 230 mm,
target 242 mm,
maximum 258 mm,
Meets Requirements of
ASTM D6319 | min 230 mm / ≥
230mm, Meets
Requirements of ASTM
D6319 | Same |
| Thickness(mm) | | | Meets
requirements of
ASTM D6319
Subject Device |
| Cuff | 0.05-0.07 | 0.032-0.050 | |
| Palm | 0.06-0.09 | 0.055-0.085 | Meets
requirements of
ASTM D6319 |
| Finger | 0.07-0.10 | 0.065-0.095 | Meets
requirements of
ASTM D6319 |
| Powder Free Residue | ≤ 2mg/glove | ≤ 2mg/glove | Same |
| Physical Properties | Meets Requirements of
ASTM D6319 | Meets Requirements of
ASTM D6319 | Same |
| Freedom from pinholes
testing | Tested in accordance
with ASTM D5151 test
method. Pass quality level
at G2 AQL 1.0 | Tested in accordance
with ASTM D5151 test
method. Pass quality
level at G1 AQL 1.5 | Tested to Same
standard. Subject
device tested to a
more stringent
criteria of G2 AQL
1.0 |
| Biocompatibility Test | | | |
| Dermal Sensitization (as
ISO 10993- 10:2010) | Not a contact sensitizer
under the
conditions of the study | Not a contact sensitizer
under the
conditions of the study | Same |
| Primary Skin Irritation
Test (as ISO 10993-
10:2010) | Not a primary skin irritant
under the
conditions of the study | Not a primary skin
irritant under
the conditions of the
study | Same |
| | | | |
| Systemic Toxicity (ISO
10993-11) | Under the conditions of
the study, no mortality or
no evidence of Systemic
Toxicity was observed | N/A | Predicate device
was not tested
for Systemic
Toxicity, Subject
device was tested
for Acute
Systemic Toxicity
and no mortality
or evidence of
Systemic Toxicity
was observed |
| Labelling Features | - Non-sterile
- Powder Free
- Examination Gloves
- Ambidextrous, by Size
- Single Use Only
- Device Color
- Manufactured Date :
- Lot Number:
- Quantity by Weight
- Made in Malaysia | - Non-sterile
- Powder Free
- Examination Gloves
- Ambidextrous, by Size
- Single Use Only
- Device Color
- Manufactured for:
- Lot Number:
- Quantity by Weight
- Made in Malaysia | Same |
| Chemotherapy Drugs
Permeation Test | | | |
| Chemotherapy Drugs
(Concentrations) | Minimum Breakthrough
Detection Time in
Minutes | Minimum Breakthrough
Detection Time in
Minutes | |
| • Carmustine (BCNU)
(3.3mg/ml),(3,300 ppm) | 5.4 | 10.1 | Below 30 minutes
permeation time,
same as the
predicate device |
| • Cisplatin (1.0mg/ml),
(1,000 ppm) | >240 | >240 | Same |
| •
Cyclophosphamide/Cytox
an(20mg/ml), (20,000
ppm) | >240 | >240 | Same |
| • Dacarbazine(DTIC)
10mg/ml, (10,000 ppm) | >240 | >240 | Same |
| • Doxorubicin
HCL(2mg/ml),(2,000 ppm) | >240 | >240 | Same |
| • Fluorouracil(50mg/ml),
(50,000 ppm) | >240 | >240 | Same |
| • Ifosfamide (50mg/ml),
(50,000 ppm) | >240 | >240 | Same |
| • Mitoxantrone(2mg/ml),(2
,000 ppm | >240 | >240 | Same |
| • Paclitaxel/Taxol(6.0mg/m
I),(6,000 ppm) | >240 | >240 | Same |
| • Thiotepa
(10mg/ml),(10,000 ppm) | 40.4 | 30.2(Blue) and
10.4(White) | Predicate device
(Blue) at 30.2
minutes;
and (White)
below 30 minutes
Subject Device
had a permeation
time of 40.4 mins
which exceeded
30 mins. less than
60 mins. |
| • Vincristine
Sulfate(1.0mg/ml),(1,000
ppm) | >240 | >240 | Same |
| Warning Statement | WARNING: Not for use
with Carmustine,
ThioTEPA | WARNING:
Do Not Use with
Carmustine and
Thiotepa | Same |
| Labelling Claim | Tested for Use with
Chemotherapy Drugs | Tested for Use with
Chemotherapy Drugs | Same |
7
30th November 2016
8
9
10
11
11.0 Conclusion
Based on intended uses, technological characteristics and non-clinical performance data, the subject device is substantially equivalent to the predicate device K151750 - Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile
The subject device meets the requirements of ASTM D 6319- 10 standards as well as applicable 21 CFR references, and meets FDA recognized standards, physical properties requirements, pinhole requirements, biocompatibility requirements and labeling claims as shown and discussed above.
Based on the complete list of non-clinical tests, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.