(249 days)
Not Found
No
The device is a physical barrier (nitrile gloves) and the description focuses on material properties and testing against chemotherapy drugs, with no mention of AI or ML.
No.
This device is a barrier protection device (examination glove) to prevent contamination, not a device intended to treat a disease or condition.
No
Explanation: The device is a nitrile examination glove intended as a barrier to prevent contamination. It does not perform any function related to diagnosis, such as detecting or identifying a disease or condition.
No
The device is a physical examination glove made from nitrile, not a software program.
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 "disposable device intended for medical purpose, to be 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 perform tests on samples from the human body to diagnose or monitor a medical condition.
- Device Description: The description focuses on the physical properties of the glove (material, color, powder-free, non-sterile) and its function as a barrier. It mentions testing for resistance to chemotherapy drugs, which is a performance characteristic of the barrier, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The device's function is purely protective.
The testing for chemotherapy drug permeation is a performance test to demonstrate the glove's suitability for a specific application (handling chemotherapy drugs), but it doesn't change the fundamental nature of the device from a barrier to an IVD.
N/A
Intended Use / Indications for Use
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a disposable device intended for medical purpose, to be 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 | Minimum Breakthrough Detection Time |
|---|---|
| • Arsenic Trioxide (0.1mg/ml),(100ppm) | >240 Minutes |
| • Bleomycin Sulfate (15mg/ml),(15,000 ppm) | >240 Minutes |
| • Busulfan(6mg/ml),(6,000 ppm) | >240 Minutes |
| • Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) | 127.5 Minutes |
| • Cisplatin (1.0mg/ml), (1,000 ppm) | >240 Minutes |
| • Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm) | >240 Minutes |
| • Cytarabine(100mg/ml), (100,000 ppm) | >240 Minutes |
| • Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) | >240 Minutes |
| • Daunorubicin(5mg/ml), (5,000 ppm) | >240 Minutes |
| • Docetaxel(10mg/ml), (10,000 ppm) | >240 Minutes |
| • Doxorubicin HCL(2mg/ml),(2,000 ppm) | >240 Minutes |
| • Ellence (2mg/ml), (2,000 ppm) | >240 Minutes |
| • Etoposide /Toposar (20mg/ml), (20,000 ppm) | >240 Minutes |
| • Fludarabine (25mg/ml), (25,000 ppm) | >240 Minutes |
| • Fluorouracil(50mg/ml), (50,000 ppm) | >240 Minutes |
| • Gemcitabine/Gemzar (38mg/ml), (38,000 ppm) | >240 Minutes |
| • Idarubicin (1.0mg/ml), (1,000 ppm) | >240 Minutes |
| • Ifosfamide (50mg/ml), (50,000 ppm) | >240 Minutes |
| • Irinotecan(20mg/ml), (20,000 ppm) | >240 Minutes |
| • Mechlorethamine HCI(1.0mg/ml), (1,000 ppm) | >240 Minutes |
| • Melphalan(5mg/ml), (5,000 ppm) | >240 Minutes |
| • Methotrexate(25mg/ml),(25,000 ppm) | >240 Minutes |
| • Mitomycin C(0.5 mg/ml), (500 ppm) | >240 Minutes |
| • Mitoxantrone(2mg/ml),(2,000 ppm) | >240 Minutes |
| • Paclitaxel(6.0mg/ml),(6,000 ppm) | >240 Minutes |
| • Paraplatin (10mg/ml),(10,000 ppm) | >240 Minutes |
| • Rituximab(10mg/ml),(10,000 ppm) | >240 Minutes |
| • Thiotepa (10mg/ml),(10,000 ppm) | >240 Minutes |
| • Trisenox(0.1mg/ml), (100 ppm) | >240 Minutes |
| • Vincristine Sulfate(1.0mg/ml).(1.000 ppm) | >240 Minutes |
Please note that the following drug noted permeation times below 240 mins: Carmustine (BCNU) 127.50 mins.
Product codes
LZA, LZC
Device Description
The subject device in this 510(k) Notification is a Purple Nitrile Examination gloves, tested for use with Chemotherapy drugs.
The subject device is a patient examination glove made from nitrile compound, Purple 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 also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy drugs as per ASTM D6978-05
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical professional/user)
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)
Study Type: Non-Clinical Performance Data
Sample Size: Not specified
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results:
Testing was performed per ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010. The glove meet standards requirement referenced in section 6.0.
Biocompatibility tests indicated that under the conditions of the studies, the gloves were nonsensitizing, non-irritating, and does not induce an acute systemic toxicity.
The device's performance characteristics for Tensile strength, Ultimate Elongation, Freedom from Pinholes, Dimensions (Length, Width, Thickness), Residual Powder, Biocompatibility (Primary Skin Irritation test, Dermal sensitization assay, Acute Systemic Toxicity), and Chemotherapy Testing (ASTM D6978-05) were compared to the predicate device and found to be "Same" or show comparable performance.
For Chemotherapy Testing, the subject device showed breakthrough detection times greater than 240 minutes for most drugs, similar to the predicate where applicable. For Carmustine (BCNU), the subject device showed a breakthrough detection time of 127.5 minutes, compared to the predicate's 30.7 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K113423: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (12") Tested for Use with Chemotherapy Drugs
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2017
Brightway Holdings Sdn Bhd. G. Baskaran Group Managing Director Lot 1559, Jalan Istimewa, Batu Belah Klang, Selangor, 42100 MY
Re: K162294
Trade/Device Name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: March 11, 2017 Received: March 15, 2017
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 device
1
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" (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/Resourcesfor You/Industry/default.htm.
Sincerely,
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
510(k) Number (if known) K162294
Device Name
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Indications for Use (Describe)
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a disposable device intended for medical purpose, to be 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 | Minimum Breakthrough Detection Time |
|---|---|
| • Arsenic Trioxide (0.1mg/ml),(100ppm) | >240 Minutes |
| • Bleomycin Sulfate (15mg/ml),(15,000 ppm) | >240 Minutes |
| • Busulfan(6mg/ml),(6,000 ppm) | >240 Minutes |
| • Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) | 127.5 Minutes |
| • Cisplatin (1.0mg/ml), (1,000 ppm) | >240 Minutes |
| • Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm) | >240 Minutes |
| • Cytarabine(100mg/ml), (100,000 ppm) | >240 Minutes |
| • Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) | >240 Minutes |
| • Daunorubicin(5mg/ml), (5,000 ppm) | >240 Minutes |
| • Docetaxel(10mg/ml), (10,000 ppm) | >240 Minutes |
| • Doxorubicin HCL(2mg/ml),(2,000 ppm) | >240 Minutes |
| • Ellence (2mg/ml), (2,000 ppm) | >240 Minutes |
| • Etoposide /Toposar (20mg/ml), (20,000 ppm) | >240 Minutes |
| • Fludarabine (25mg/ml), (25,000 ppm) | >240 Minutes |
| • Fluorouracil(50mg/ml), (50,000 ppm) | >240 Minutes |
| • Gemcitabine/Gemzar (38mg/ml), (38,000 ppm) | >240 Minutes |
| • Idarubicin (1.0mg/ml), (1,000 ppm) | >240 Minutes |
| • Ifosfamide (50mg/ml), (50,000 ppm) | >240 Minutes |
| • Irinotecan(20mg/ml), (20,000 ppm) | >240 Minutes |
| • Mechlorethamine HCI(1.0mg/ml), (1,000 ppm) | >240 Minutes |
| • Melphalan(5mg/ml), (5,000 ppm) | >240 Minutes |
| • Methotrexate(25mg/ml),(25,000 ppm) | >240 Minutes |
| • Mitomycin C(0.5 mg/ml), (500 ppm) | >240 Minutes |
| • Mitoxantrone(2mg/ml),(2,000 ppm) | >240 Minutes |
| • Paclitaxel(6.0mg/ml),(6,000 ppm) | >240 Minutes |
| • Paraplatin (10mg/ml),(10,000 ppm) | >240 Minutes |
| • Rituximab(10mg/ml),(10,000 ppm) | >240 Minutes |
| • Thiotepa (10mg/ml),(10,000 ppm) | >240 Minutes |
| • Trisenox(0.1mg/ml), (100 ppm) | >240 Minutes |
| • Vincristine Sulfate(1.0mg/ml).(1.000 ppm) | >240 Minutes |
Please note that the following drug noted permeation times below 240 mins: Carmustine (BCNU) 127.50 mins.
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)
3
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4
510(K) SUMMARY
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY 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 |
-
- Preparation Date : 12th April 2017
- Name of the Device :
Device trade or proprietary name: K162294 - BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Device Classification Name: Polymer Patient Examination Glove
(21 CFR 880.6250)
5
Device common or usual name: NITRILE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
FDA Device Class : Class 1
Product Code : LZC , LZA
-
- Identification of the Device :
Class I patient Examination Nitrile gloves, Powder Free, LZA, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.
- Identification of the Device :
Predicate Device:
Legally Marketed Devices to which Substantial Equivalence is claimed: K113423: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (12") Tested for Use with Chemotherapy Drugs
5. Device Description :
The subject device in this 510(k) Notification is a Purple Nitrile Examination gloves, tested for use with Chemotherapy drugs.
The subject device is a patient examination glove made from nitrile compound, Purple 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 also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy drugs as per ASTM D6978-05
6
6. Intended use of the Device
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a disposable device intended for medical purpose, to be 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 | Minimum Breakthrough Detection Time | |
|---|---|---|
| ● | Arsenic Trioxide (0.1mg/ml),(100ppm) | >240 Minutes |
| ● | Bleomycin Sulfate (15mg/ml),(15,000 ppm) | >240 Minutes |
| ● | Busulfan(6mg/ml),(6,000 ppm) | >240 Minutes |
| ● | Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) | 127.5 Minutes |
| ● | Cisplatin(1.0mg/ml), (1,000 ppm) | >240 Minutes |
| ● | Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm) | >240 Minutes |
| ● | Cytarabine(100mg/ml), (100,000 ppm) | >240 Minutes |
| ● | Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) | >240 Minutes |
| ● | Daunorubicin(5mg/ml), (5,000 ppm) | >240 Minutes |
| ● | Docetaxel(10mg/ml), (10,000 ppm) | >240 Minutes |
| ● | Doxorubicin HCL(2mg/ml),(2,000 ppm) | >240 Minutes |
| ● | Ellence (2mg/ml), (2,000 ppm) | >240 Minutes |
| ● | Etoposide /Toposar (20mg/ml), (20,000 ppm) | >240 Minutes |
| ● | Fludarabine (25mg/ml), (25,000 ppm) | >240 Minutes |
| ● | Fluorouracil(50mg/ml), (50,000 ppm) | >240 Minutes |
| ● | Gemcitabine/Gemzar (38mg/ml), (38,000 ppm) | >240 Minutes |
| ● | Idarubicin(1.0mg/ml), (1,000 ppm) | >240 Minutes |
| ● | Ifosfamide (50mg/ml), (50,000 ppm) | >240 Minutes |
| ● | Irinotecan(20mg/ml), (20,000 ppm) | >240 Minutes |
| ● | Mechlorethamine HCI(1.0mg/ml), (1,000 ppm) | >240 Minutes |
| ● | Melphalan(5mg/ml), (5,000 ppm) | >240 Minutes |
| ● | Methotrexate(25mg/ml),(25,000 ppm) | >240 Minutes |
| ● | Mitomycin C(0.5 mg/ml), (500 ppm) | >240 Minutes |
| ● | Mitoxantrone(2mg/ml),(2,000 ppm) | >240 Minutes |
| ● | Paclitaxel(6.0mg/ml),(6,000 ppm) | >240 Minutes |
| ● | Paraplatin (10mg/ml),(10,000 ppm) | >240 Minutes |
| ● | Rituximab(10mg/ml),(10,000 ppm) | >240 Minutes |
| ● | Thiotepa (10mg/ml),(10,000 ppm) | >240 Minutes |
| ● | Trisenox(0.1mg/ml), (100 ppm) | >240 Minutes |
| ● | Vincristine Sulfate(1.0mg/ml),(1,000 ppm) | >240 Minutes |
Please note that the following drug noted permeation times below 240 mins: Carmustine (BCNU) 127.50 mins.
7
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. The glove meet standards requirement referenced in section 6.0 above.
Biocompatibility tests indicated that under the conditions of the studies, the gloves were nonsensitizing, non-irritating, and does not induce an acute systemic toxicity.
8. Summary of Technical Characteristics and Substantial Equivalence Compared to Predicate Device :
The predicate device in scope is as follows:
K113423: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (12") Tested for Use with Chemotherapy Drugs
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is substantially equivalent in safety and effectiveness to K113423: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (12") Tested for Use with Chemotherapy Drugs
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:
8
| Device Performance | ||||||
|---|---|---|---|---|---|---|
| Characteristics | Standard | K113423: | ||||
| Kimberly- | ||||||
| Clark | ||||||
| PURPLE | ||||||
| NITRILE* | ||||||
| Powder- | ||||||
| Free Exam | ||||||
| Gloves - | ||||||
| 9.5" | ||||||
| Length | K113423: | |||||
| Kimberly- | ||||||
| Clark | ||||||
| PURPLE | ||||||
| NITRILE- | ||||||
| XTRA* | ||||||
| Powder- | ||||||
| Free Exam | ||||||
| Gloves - | ||||||
| 12" | ||||||
| Length | Predicate | |||||
| Device | ||||||
| K113423: | ||||||
| Kimberly-Clark | ||||||
| PURPLE | ||||||
| NITRILE-XTRA* | ||||||
| Powder-Free | ||||||
| Exam Gloves | ||||||
| (12") | ||||||
| Tested for Use | ||||||
| with | ||||||
| Chemotherapy | ||||||
| Drugs | Subject Device: | |||||
| BRIGHTWAY | ||||||
| BRAND NITRILE | ||||||
| EXAMINATION | ||||||
| GLOVES 12", | ||||||
| POWDER FREE, | ||||||
| [PURPLE] | ||||||
| TESTED FOR | ||||||
| USE WITH | ||||||
| CHEMOTHERAP | ||||||
| Y DRUGS | Result of | |||||
| Comparison | ||||||
| PREDICATE | ||||||
| DEVICE MAIN | ||||||
| COMPARISON | SUBJECT DEVICE | |||||
| MAIN | ||||||
| COMPRISON | ||||||
| Labeling | N/A | There are | ||||
| no special | ||||||
| labeling | ||||||
| claims and | ||||||
| do not | ||||||
| claim | ||||||
| gloves as | ||||||
| hypoallerg | ||||||
| enic on | ||||||
| labels. | There are | |||||
| no special | ||||||
| labeling | ||||||
| claims and | ||||||
| do not | ||||||
| claim | ||||||
| gloves as | ||||||
| hypoallerg | ||||||
| enic on | ||||||
| labels. | There are no | |||||
| special labeling | ||||||
| claims and do | ||||||
| not claim | ||||||
| gloves as | ||||||
| hypoallergenic | ||||||
| on labels. | There are no | |||||
| special labeling | ||||||
| claims and do | ||||||
| not claim gloves | ||||||
| as | ||||||
| hypoallergenic | ||||||
| on labels. | Same | |||||
| Device Materials | N/A | Nitrile | ||||
| Compoun | ||||||
| d | Nitrile | |||||
| Compoun | ||||||
| d | Nitrile | |||||
| Compound | Nitrile | |||||
| Compound | Same | |||||
| Colour | N/A | Purple | Purple | Purple | Purple | Same |
9
| Device Tolerances and Specifications & Performance Data | ||||||
|---|---|---|---|---|---|---|
| Tensile strength : | ||||||
| Before and after | ||||||
| ageing | ASTM | |||||
| 6319-10 | > 14 Mpa | > 14 Mpa | > 14 Mpa | > 14 Mpa | Same | |
| Ultimate | ||||||
| Elongation: | ||||||
| Before and after | ||||||
| ageing | ASTM | |||||
| 6319-10 | > 500 % | > 500 % | > 500 % | > 500 % | Same | |
| Freedom from | ||||||
| Pinholes | ASTM | |||||
| 6319-10 | ||||||
| (FDA 1000 | ||||||
| ml water | ||||||
| leak test) | Pass | Pass | Pass | Pass | Same | |
| Dimensions | ||||||
| Length | ASTM | |||||
| 6319-10 | > 235 mm | > 295 mm | > 295 mm | > 295 mm | ||
| (295 mm | ||||||
| minimum -325 | ||||||
| mm) | Same | |||||
| Width | ASTM | |||||
| 6319-10 | 70±10 mm | |||||
| to 120±10 | ||||||
| mm (sizes | ||||||
| XS to XL) | 70±10 mm | |||||
| to 120±10 | ||||||
| mm (sizes | ||||||
| XS to XL) | 70±10 mm to | |||||
| 120±10 mm | ||||||
| (sizes XS to XL) | 70±10 mm to | |||||
| 120±10 mm | ||||||
| (sizes XS to XL) | Same | |||||
| Thickness | ASTM | |||||
| 6319-10 | > 0.05 mm | |||||
| (Palm | ||||||
| 0.12mm | ||||||
| Finger : | ||||||
| 0.15mm) | > 0.05 mm | |||||
| (Palm | ||||||
| 0.12mm | ||||||
| Finger : | ||||||
| 0.15mm) | > 0.05 mm | |||||
| (Palm 0.12mm | ||||||
| Finger : | ||||||
| 0.15mm) | > 0.05 mm | |||||
| (Palm :0.14mm- | ||||||
| 0.18mm Finger : | ||||||
| 0.20mm- | ||||||
| 0.24mm) | Same | |||||
| Residual Powder : | ASTM | |||||
| D6124 | Less than | |||||
| 2 mg per | ||||||
| glove ; | ||||||
| PASS | Less than | |||||
| 2 mg per | ||||||
| glove ; | ||||||
| PASS | Less than 2 mg | |||||
| per glove ; | ||||||
| PASS | Less than 2 mg | |||||
| per glove ; PASS | Same |
10
| Biocompatibility | ||||||
|---|---|---|---|---|---|---|
| Primary Skin | ||||||
| Irritation test | ISO | |||||
| 10993-10 | Under | |||||
| conditions | ||||||
| of the | ||||||
| study, not | ||||||
| an irritant | Under | |||||
| conditions | ||||||
| of the | ||||||
| study, not | ||||||
| an irritant | Under | |||||
| conditions of | ||||||
| the study, not | ||||||
| an irritant | Under | |||||
| conditions of | ||||||
| the study, not | ||||||
| an irritant | Same | |||||
| Dermal | ||||||
| sensitization assay | ISO | |||||
| 10993-10 | Under | |||||
| conditions | ||||||
| of the | ||||||
| study, not | ||||||
| a | ||||||
| sensitizer | Under | |||||
| conditions | ||||||
| of the | ||||||
| study, not | ||||||
| a | ||||||
| sensitizer | Under | |||||
| conditions of | ||||||
| the study, not | ||||||
| a sensitizer | Under | |||||
| conditions of | ||||||
| the study, not a | ||||||
| sensitizer | Same | |||||
| Acute Systemic | ||||||
| Toxicity | ISO | |||||
| 10993-11 | Under | |||||
| conditions | ||||||
| of the | ||||||
| study, the | ||||||
| device | ||||||
| does not | ||||||
| induce | ||||||
| acute | ||||||
| systemic | ||||||
| toxicity | Under | |||||
| conditions | ||||||
| of the | ||||||
| study, the | ||||||
| device | ||||||
| does not | ||||||
| induce | ||||||
| acute | ||||||
| systemic | ||||||
| toxicity | Under | |||||
| conditions of | ||||||
| the study, the | ||||||
| device does | ||||||
| not induce | ||||||
| acute systemic | ||||||
| toxicity | Under | |||||
| conditions of the | ||||||
| study, the device | ||||||
| does not induce | ||||||
| acute systemic | ||||||
| toxicity | Same | |||||
| Chemotherapy Testing ASTM D6978-05 | ||||||
| Test | ||||||
| CHEMOTHERAPY | ||||||
| Drug Name | Drug | |||||
| Concentra | ||||||
| tion | Minimum Breakthrough Detection Time (minutes) | |||||
| Arsenic Trioxide | 0.1mg/ml | N/A | N/A | - | > 240 | Predicate not |
| tested, | ||||||
| Subject Device | ||||||
| tested and | ||||||
| showed no | ||||||
| breakthrough | ||||||
| after 240mins | ||||||
| Bleomycin Sulfate | 15mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Busulfan | 6mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Carmustine BCNU | 3.3mg/ml | N/A | N/A | 30.7 | > 127.5 | Predicated |
| Device | ||||||
| breakthrough | ||||||
| at 30.7 | ||||||
| Minutes. | ||||||
| Subject device | ||||||
| noted | ||||||
| permeation | ||||||
| times below | ||||||
| 240 mins: | ||||||
| Carmustine | ||||||
| (BCNU) 127.50 | ||||||
| mins. | ||||||
| Cisplatin | 1.0mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Cyclophosphamide/ | ||||||
| Cytoxan | 20mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Cytarabine | 100mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Dacarbazine (DTIC) | 10mg/ml, | N/A | N/A | > 240 | > 240 | Same |
| Daunorubicin | 5mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Docetaxel | 10mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Doxorubicin HCL | 2mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Ellence | 2mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Etoposide /Toposar | 20mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Fludarabine | 25mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Fluorouracil | 50mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Gemcitabine/ | ||||||
| Gemzar | 38mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Idarubicin | 1.0mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Ifosfamide | 50mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Irinotecan | 20mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Mechlorethamine | ||||||
| HCl | 1.0mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Melphalan | 5mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Methotrexate | 25mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Mitomycin C | 0.5 mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Mitoxantrone | 2mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Paclitaxel | 6.0mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Paraplatin | ||||||
| (Carboplatin) | 10mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Rituximab | 10mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Thiotepa | 10mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Trisenox | 0.1mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Vincristine Sulfate | 1.0mg/ml | N/A | N/A | > 240 | > 240 | Same |
| Warning Statement | ASTM | |||||
| D6978-05 | N/A | N/A | Please note | |||
| that the | ||||||
| following drug | ||||||
| has low | ||||||
| permeation | ||||||
| times of less | ||||||
| than 60 | ||||||
| minutes: | ||||||
| Carmustine | ||||||
| (BCNU) 30.7 | ||||||
| mins. | Please note that | |||||
| the following | ||||||
| drug noted | ||||||
| permeation | ||||||
| times below 240 | ||||||
| mins: | ||||||
| Carmustine | ||||||
| (BCNU) 127.50 | ||||||
| mins. | Same |
11
12
12.0 Conclusion
Based on intended uses, technological characteristics and Non-Clinical performance data, the subject device; BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12″, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is substantially equivalent to the predicate device K113423: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (12") Tested for Use with Chemotherapy Drugs
The subject device meets the requirements of ASTM D 6319- 10 standards as well as applicable 21 CFR references, and meets FDA recognized standards for physical properties requirements, pinhole requirements, biocompatibility requirements which are as shown and discussed above.
Based on the complete list of non-clinical tests, the subject device herein mentioned, is as safe, as effective, and performs as well as the legally marketed predicate device.