(249 days)
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:
• 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.
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
This document describes the premarket notification (510(k)) for BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS, seeking to prove substantial equivalence to a predicate device. The "acceptance criteria" here refers to the performance standards and regulatory requirements that the device must meet to be considered substantially equivalent to a legally marketed predicate device, rather than specific AI/ML performance metrics. Similarly, the "study" proving the device meets these criteria refers to the non-clinical testing performed on the gloves.
Given the nature of the device (examination gloves), the concepts of "AI assistance," "human observers," "training set," and "ground truth" (in the context of expert consensus or pathology for medical images/diagnoses) are not applicable. The "study" here is a series of non-clinical, laboratory-based tests to demonstrate the physical properties, biocompatibility, and chemical permeation resistance of the gloves.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by recognized industry standards (ASTM, ISO) and FDA regulations. The reported device performance is the outcome of testing against these standards.
Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Standard | Acceptance Criteria (from Standard) | Reported Device Performance (Subject Device) | Result of Comparison |
|---|---|---|---|
| Labeling | No special labeling claims, no hypoanergic claims | No special labeling claims, no hypoanergic claims | Same |
| Device Materials | Nitrile Compound | Nitrile Compound | Same |
| Colour | Purple | Purple | Same |
| Tensile strength (Before and after ageing) - ASTM 6319-10 | > 14 Mpa | > 14 Mpa | Same |
| Ultimate Elongation (Before and after ageing) - ASTM 6319-10 | > 500 % | > 500 % | Same |
| Freedom from Pinholes (ASTM 6319-10, FDA 1000ml water leak test) | Pass | Pass | Same |
| Length (ASTM 6319-10) | > 295 mm (for 12" glove) | > 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) | Same |
| Thickness (ASTM 6319-10) | > 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 | Same |
| Primary Skin Irritation test (ISO 10993-10) | 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 | Same |
| Acute Systemic Toxicity (ISO 10993-11) | Under conditions of the study, device does not induce acute systemic toxicity | Under conditions of the study, device does not induce acute systemic toxicity | Same |
| Chemotherapy Drug Permeation (ASTM D6978-05) | |||
| - Arsenic Trioxide (0.1mg/ml) | (No specific predicate value provided for comparison) | > 240 Minutes | N/A (Predicate not tested, Subject Device passed) |
| - Bleomycin Sulfate (15mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Busulfan (6mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Carmustine (BCNU) (3.3mg/ml) | 30.7 Minutes (Predicate) | 127.5 Minutes | Subject device showed significantly longer breakthrough time. |
| - Cisplatin (1.0mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Cyclophosphamide/Cytoxan (20mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Cytarabine (100mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Dacarbazine (DTIC) (10mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Daunorubicin (5mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Docetaxel (10mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Doxorubicin HCL (2mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Ellence (2mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Etoposide /Toposar (20mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Fludarabine (25mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Fluorouracil (50mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Gemcitabine/Gemzar (38mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Idarubicin (1.0mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Ifosfamide (50mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Irinotecan (20mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Mechlorethamine HCl (1.0mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Melphalan (5mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Methotrexate (25mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Mitomycin C (0.5 mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Mitoxantrone (2mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Paclitaxel (6.0mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Paraplatin (Carboplatin) (10mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Rituximab (10mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Thiotepa (10mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Trisenox (0.1mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| - Vincristine Sulfate (1.0mg/ml) | > 240 Minutes | > 240 Minutes | Same |
| Warning Statement (ASTM D6978-05) | Acknowledge drugs with low permeation times | Acknowledge Carmustine (BCNU) 127.50 mins permeation time | Same (Both predicate and subject device have warning statements for specific drugs, though the specific drug and time differ due to varied performance) |
Study Information (Non-Clinical Testing for Gloves)
Since this is a filing for medical examination gloves, the concepts below regarding AI/ML studies are not directly applicable. However, I will interpret them in the context of the testing performed on these physical devices.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not explicitly state the number of gloves tested for each characteristic (e.g., how many gloves were tested for pinholes, or how many samples for tensile strength). The standards referenced (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010, ASTM D6978-05) would specify the required sample sizes for each test.
- Data Provenance: The testing was performed according to international harmonized standards (ASTM, ISO). The manufacturer is Brightway Holdings Sdn Bhd. from Malaysia (Lot 1559, Jalan Istimewa, Batu Belah Klang, Selangor, 42100 MY). The data is implicitly prospective, as it was generated specifically for this 510(k) submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable in the AI/ML context. For physical device testing, the "ground truth" is established by the test methods themselves, defined by standards organizations (ASTM, ISO). The "experts" would be the certified laboratory technicians and engineers who perform the tests according to the standard operating procedures and interpret the results against the specified criteria. Their qualifications would be in laboratory science, materials testing, and adherence to quality systems.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable in the AI/ML context. For physical device testing, results are typically quantitative measurements or pass/fail determinations based on predefined criteria in the standards. Discrepancies would be resolved through re-testing or investigation into the test methodology, not through human consensus or adjudication of interpretations.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical medical device (examination glove), not an AI/ML diagnostic or assistive tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" is based on standardized test methods and predefined quantitative/qualitative thresholds set by organizations like ASTM and ISO. For example, for "Freedom from Pinholes," the ground truth is a "Pass" or "Fail" based on a specified water leak test (FDA 1000ml water leak test) as incorporated into ASTM 6319-10. For chemotherapy permeation, the ground truth is the "breakthrough detection time" measured in minutes. Biocompatibility tests rely on established in-vitro and in-vivo assays with pass/fail criteria for irritation, sensitization, and toxicity.
-
The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML model that requires a training set. The manufacturing process is consistent, and quality control ensures consistency, but there isn't a "training set" in the AI sense.
-
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.
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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
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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)
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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:
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| Device Performance | ||||||
|---|---|---|---|---|---|---|
| Characteristics | Standard | K113423:Kimberly-ClarkPURPLENITRILE*Powder-Free ExamGloves -9.5"Length | K113423:Kimberly-ClarkPURPLENITRILE-XTRA*Powder-Free ExamGloves -12"Length | PredicateDeviceK113423:Kimberly-ClarkPURPLENITRILE-XTRA*Powder-FreeExam Gloves(12")Tested for UsewithChemotherapyDrugs | Subject Device:BRIGHTWAYBRAND NITRILEEXAMINATIONGLOVES 12",POWDER FREE,[PURPLE]TESTED FORUSE WITHCHEMOTHERAPY DRUGS | Result ofComparison |
| PREDICATEDEVICE MAINCOMPARISON | SUBJECT DEVICEMAINCOMPRISON | |||||
| Labeling | N/A | There areno speciallabelingclaims anddo notclaimgloves ashypoallergenic onlabels. | There areno speciallabelingclaims anddo notclaimgloves ashypoallergenic onlabels. | There are nospecial labelingclaims and donot claimgloves ashypoallergenicon labels. | There are nospecial labelingclaims and donot claim glovesashypoallergenicon labels. | Same |
| Device Materials | N/A | NitrileCompound | NitrileCompound | NitrileCompound | NitrileCompound | Same |
| Colour | N/A | Purple | Purple | Purple | Purple | Same |
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| Device Tolerances and Specifications & Performance Data | ||||||
|---|---|---|---|---|---|---|
| Tensile strength :Before and afterageing | ASTM6319-10 | > 14 Mpa | > 14 Mpa | > 14 Mpa | > 14 Mpa | Same |
| UltimateElongation:Before and afterageing | ASTM6319-10 | > 500 % | > 500 % | > 500 % | > 500 % | Same |
| Freedom fromPinholes | ASTM6319-10(FDA 1000ml waterleak test) | Pass | Pass | Pass | Pass | Same |
| Dimensions | ||||||
| Length | ASTM6319-10 | > 235 mm | > 295 mm | > 295 mm | > 295 mm(295 mmminimum -325mm) | Same |
| Width | ASTM6319-10 | 70±10 mmto 120±10mm (sizesXS to XL) | 70±10 mmto 120±10mm (sizesXS to XL) | 70±10 mm to120±10 mm(sizes XS to XL) | 70±10 mm to120±10 mm(sizes XS to XL) | Same |
| Thickness | ASTM6319-10 | > 0.05 mm(Palm0.12mmFinger :0.15mm) | > 0.05 mm(Palm0.12mmFinger :0.15mm) | > 0.05 mm(Palm 0.12mmFinger :0.15mm) | > 0.05 mm(Palm :0.14mm-0.18mm Finger :0.20mm-0.24mm) | Same |
| Residual Powder : | ASTMD6124 | Less than2 mg perglove ;PASS | Less than2 mg perglove ;PASS | Less than 2 mgper glove ;PASS | Less than 2 mgper glove ; PASS | Same |
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| Biocompatibility | ||||||
|---|---|---|---|---|---|---|
| Primary SkinIrritation test | ISO10993-10 | Underconditionsof thestudy, notan irritant | Underconditionsof thestudy, notan irritant | Underconditions ofthe study, notan irritant | Underconditions ofthe study, notan irritant | Same |
| Dermalsensitization assay | ISO10993-10 | Underconditionsof thestudy, notasensitizer | Underconditionsof thestudy, notasensitizer | Underconditions ofthe study, nota sensitizer | Underconditions ofthe study, not asensitizer | Same |
| Acute SystemicToxicity | ISO10993-11 | Underconditionsof thestudy, thedevicedoes notinduceacutesystemictoxicity | Underconditionsof thestudy, thedevicedoes notinduceacutesystemictoxicity | Underconditions ofthe study, thedevice doesnot induceacute systemictoxicity | Underconditions of thestudy, the devicedoes not induceacute systemictoxicity | Same |
| Chemotherapy Testing ASTM D6978-05 | ||||||
| TestCHEMOTHERAPYDrug Name | DrugConcentration | Minimum Breakthrough Detection Time (minutes) | ||||
| Arsenic Trioxide | 0.1mg/ml | N/A | N/A | - | > 240 | Predicate nottested,Subject Devicetested andshowed nobreakthroughafter 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 | PredicatedDevicebreakthroughat 30.7Minutes.Subject devicenotedpermeationtimes below240 mins:Carmustine(BCNU) 127.50mins. |
| 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 |
| MechlorethamineHCl | 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 | ASTMD6978-05 | N/A | N/A | Please notethat thefollowing drughas lowpermeationtimes of lessthan 60minutes:Carmustine(BCNU) 30.7mins. | Please note thatthe followingdrug notedpermeationtimes below 240mins:Carmustine(BCNU) 127.50mins. | Same |
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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.
§ 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.