(129 days)
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY 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 | Minimum Breakthrough Detection Time |
|---|---|
| · Blenoxane (15mg/ml),(15,000 ppm) | >240 Minutes |
| · Busulfan(6mg/ml),(6,000 ppm) | >240 Minutes |
| · Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) | 3.6 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 (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) | 15.9 Minutes |
| · Trisenox(0.1mg/ml), (100 ppm) | >240 Minutes |
| · Vincristine Sulfate(1.0mg/ml),(1,000 ppm) | >240 Minutes |
Please note that Carmustine and Thiotepa have extremely low permeation times of 3,6 minutes, respectively
WARNING: Do Not Use With : Carmustine, ThioTEPA
The subject device in this 510(k) Notification is a Purple Nitrile Examination glove tested for use with Chemotherapy drugs.
The subject device is a patient examination glove made from nitrile compound, Purple 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.
The provided document pertains to a 510(k) premarket notification for "BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS." This is a Class I medical device, and the submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K992162 Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim).
The document does not describe an AI/ML-based device or a study involving human readers and AI assistance for medical image analysis. Instead, it details the physical and chemical properties of examination gloves, their resistance to chemotherapy drugs, and their biocompatibility, as per standard testing protocols for such devices.
Therefore, many of the requested elements for an AI/ML device study (e.g., sample size for AI test and training sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, AI effect size) are not applicable to this document.
However, I can extract the acceptance criteria and performance data relevant to this specific device (examination gloves):
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards as outlined in the document, and demonstrating performance comparable to the predicate device. The reported performance indicates compliance with these standards.
| Device Characteristics | Test Standard | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|---|
| Product: Nitrile Examination Gloves, Powder Free (Purple) Tested For Use with Chemotherapy Drugs | |||
| Primary Function: Barrier protection to prevent contamination between patient and examiner. Tested for resistance to permeation by chemotherapy drugs. | |||
| Chemical Permeation: | ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs) | Minimum breakthrough detection times for various chemotherapy drugs, typically >240 minutes for most tested drugs. Special note for drugs with low permeation times. | Met or exceeded >240 minutes for most tested drugs. Carmustine (3.3mg/ml): 3.6 minutes; Thiotepa (10mg/ml): 15.9 minutes. (These values are declared and warned against, indicating they meet the disclosure requirement but are below the general >240 min goal, hence the warning). The device meets the requirement by truthfully reporting its performance for each chemical. |
| Physical Attributes (General): | ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves) | Compliance with all requirements in ASTM D6319-10, including dimensions, physical properties (tensile strength, elongation). | Complies with ASTM D6319-10 both before and after accelerated aging. All sizes comply with length, width, and thickness dimensions. |
| Freedom from Holes: | ASTM D6319-10 by D5151-06 | Must meet specified AQL (Acceptable Quality Level) for freedom from holes. | Pass (Implies meeting or exceeding the AQL). |
| Powder Free Designation: | ASTM D6319-10 by D6124-06 | Less than 2.0 mg powder per glove. | Less than 2.0 mg per glove; Pass. |
| Biocompatibility: | ISO 10993-10:2010 (Reapproved 2014) | Not a skin irritant; Not a skin sensitizer. | Under conditions of the test, not a skin irritant; Under conditions of the test, not a skin sensitizer. |
| ISO 10993-11:2006 (Reapproved 2010) | Does not cause systemic toxicity. | Under conditions of the test, does not cause systemic toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific number of gloves (sample size) for each particular test. However, it references standards like ASTM D6319-10 and ISO 2859 (Sampling Procedures and Tables for Inspection by Attributes), which would dictate the appropriate sample sizes for the various tests (e.g., tensile strength, dimensions, pinholes, chemotherapy drug permeation). For example, ASTM D6978-05 for chemotherapy drug permeation typically involves testing a specified number of samples (often 3 replicates) per drug, which are then averaged or used to determine breakthrough time.
- Data Provenance: The testing was "non-clinical performance data" (Section 7). The manufacturing company, Brightway Holdings Sdn. Bhd., is located in Malaysia (Section 3). The testing was conducted according to international standards (ASTM, ISO), meaning the data provenance is from laboratory tests, not from human retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a physical device being tested against established ASTM and ISO standards in a laboratory setting. There is no concept of "ground truth" derived from human expert interpretation (like medical images) for this type of product. The "ground truth" is defined by the objective measurements and protocols outlined in the referenced standards.
4. Adjudication Method for the Test Set
- Not Applicable. As this involves laboratory testing against objective standards (e.g., measuring breakthrough time, tensile strength), there is no human adjudication process involved in establishing "ground truth" or test results in the way it would be for interpreting medical images. The measurements are taken by lab technicians and reported against the standard's pass/fail criteria or quantitative thresholds.
5. 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 document is for examination gloves, not an AI/ML device. Therefore, no MRMC study with human readers or AI assistance was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is for examination gloves, not an AI/ML algorithm.
7. The Type of Ground Truth Used
- Ground Truth: The "ground truth" for this device is defined by objective, standardized measurements and laboratory test results as per recognized ASTM and ISO international standards.
- For chemotherapy drug permeation: Breakthrough time measured according to ASTM D6978-05.
- For physical properties (tensile strength, elongation, dimensions, holes): Measured according to ASTM D6319-10 and its referenced sub-standards (e.g., ASTM D412, D5151).
- For biocompatibility: Biological responses (irritation, sensitization, systemic toxicity) measured according to ISO 10993-10 and ISO 10993-11.
8. The Sample Size for the Training Set
- Not Applicable. As this is not an AI/ML device, there are no training sets in the context of machine learning. The "training" for manufacturing occurs through process control and quality management systems to ensure consistent product performance.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. No AI/ML training set is involved.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2017
Brightway Holdings Sdn. Bhd. % Dr. Wava Truscott Consultant Truscott Medsci Associates, LLC 180 Burkemeade Ct Roswell. Georgia 30075
Re: K170686
Trade/Device Name: Nitrile Examination Gloves, Powder Free (Purple) 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: June 25, 2017 Received: June 26, 2017
Dear Dr. Truscott:
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
{1}------------------------------------------------
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tara A. Ryan -S
for
Lori Wiggins 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 below.
510(k) Number (if known)
Device Name
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUG5
Indications for Use (Describe)
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY 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 | Minimum Breakthrough Detection Time |
|---|---|
| · Blenoxane (15mg/ml),(15,000 ppm) | >240 Minutes |
| · Busulfan(6mg/ml),(6,000 ppm) | >240 Minutes |
| · Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) | 3.6 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 (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) | 15.9 Minutes |
| · Trisenox(0.1mg/ml), (100 ppm) | >240 Minutes |
| · Vincristine Sulfate(1.0mg/ml),(1,000 ppm) | >240 Minutes |
Please note that Carmustine and Thiotepa have extremely low permeation times of 3,6 minutes, respectively
WARNING: Do Not Use With : Carmustine, ThioTEPA
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)
FORM FDA 3881 (8/14)
Page 1 of 2
PSC Publishing Services (301) 443-6740 EF
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K170686 510(K) SUMMARY
13
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, 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 : July 13, 2017
-
Name of the Device :
Device trade or proprietary name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE[PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS
{4}------------------------------------------------
Device Classification Name: Polymer Patient Examination Glove (21 CFR 88-6250)
Device common or usual name: Powder-Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
FDA Device Class : Class 1
Product Code : LZC, LZA
-
- ldentification of the Device :
This Class 1 medical device; product code LZA, LZC with the Trade Name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE (Purple) TESTED FOR USE WITH CHEMOTHERAPY DRUGS, was tested for Chemotherapy drug penetration resistance per ASTM D6978-05 and meets all the requirements of ASTM D6319-10 and FDA 21 CFR 880.6250.
- ldentification of the Device :
Predicate device:
Legally marked device to which substantial equivalence is claimed:
-
- K992162 Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim
-
- Device Description :
The subject device in this 510(k) Notification is a Purple Nitrile Examination glove tested for use with Chemotherapy drugs.
The subject device is a patient examination glove made from nitrile compound, Purple 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.
{5}------------------------------------------------
6. Intended use of the Device / Indication of Use
ੇ ਮੁੱਤਰ
BRIGHTWAY BRAND EXAMINATION GLOVES, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.
This device has been tested with chemotherapy drugs and their breakthrough detection times are as follows:
Test Chemotherapy Drug Name and Concentration
| Test Chemotherapy Drug Name and Concentration | Minimum Breakthrough Detection Time | |
|---|---|---|
| • | Blenoxane (15mg/ml), (15,000 ppm) | >240 Minutes |
| • | Busulfan(6mg/ml),(6,000 ppm) | >240 Minutes |
| • | Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) | 3.6 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 (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) | 15.9 Minutes |
| • | Trisenox(0.1mg/ml), (100 ppm) | >240 Minutes |
| • | Vincristine Sulfate(1.0mg/ml), (1,000 ppm) | >240 Minutes |
Please Note: Carmustine and ThioTEPA have extremely low permeation times with breakthrough detected in less than 30 minutes: Carmustine (3.3mg/mL): 3.6 minutes; ThioTEPA (10mg/mL): 15.9 minutes WARNING: Not for Use with: Carmustine, ThioTEPA
{6}------------------------------------------------
7. Substantial Equivalence Based on Assessment of Non-Clinical Performance Data
a.) Testing was performed per ASTM D6319: Standard Specification for Nitrile Examination Gloves for Medical Application, utilizing the currently re-approved versions of the test methods there-in referenced:
- ASTM D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers— ● Tension
- ASTM D573 Test Method for Rubber—Deterioration in an Air Oven
- ASTM D3578 Specification for Rubber Examination Gloves
- ASTM D3767 Practice for Rubber—Measurement of Dimensions
- o ASTM D5151 Test Method for Detection of Holes in Medical Gloves
- ASTM D6124 Test Method for Residual Powder on Medical Gloves
- ISO 2859 Sampling Procedures and Tables for Inspection by Attributes
Test results show that under the conditions of the testing, there is no difference in physical attributes between the proposed device and the predicate device.
b.) Both the proposed device and the predicate were tested for use with chemotherapy drugs per:
-
o ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
c.) Biocompatibility testing was performed utilizing: -
. ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for Irritation and Sensitization. Both dermal irritation and sensitization (Magnusson & Kingman) were performed.
-
. ISO 10993-11: Biological evaluation of medical devices – Part 11: Tests for Systemic toxicity were conducted as had been performed on the predicate device.
Both the proposed device and the predicate device demonstrated that they were nonirritating and non-sensitizing, and that they did not demonstrate systemic toxicity under conditions of the studies performed.
All testing performed demonstrated that under the conditions of the test or study conducted, that the proposed medical device and the predicate device performed the same or similarly.
8. A summary, side by side Comparison Table is presented:
{7}------------------------------------------------
510(k) Summary Table
Comparison of Proposed Device to Predicate Device (pg. 1 of 2)
| DeviceCharacteristics | TestStandard | Proposed Device | Predicate DeviceK992162 | ComparisonAnalysis |
|---|---|---|---|---|
| Trade Name | N/A | Brightway Brand NitrileExamination Gloves, PowderFree, [Purple] Tested for Usewith Chemotherapy Drugs | Safeskin Purple Powder-FreeNitrile Examination Gloves Testedfor use with Chemotherapy Drugs | Similar |
| 510(k)Reference | N/A | K992162 | N/A | |
| Common Name | N/A | Patient Examination Glove | Patient Examination Glove | Same |
| Product Code | N/A | LZA, LZC | LZA, LZC | Same |
| Intended use | N/A | A powder-free patientexamination glove is adisposable device intended formedical purposes that is wornon the examiners hand or fingerto prevent contaminationbetween patient and examiner.Additionally, the gloves weretested for use withchemotherapy drugs inaccordance with ASTM D6978-05 Standard Practice forAssessment of Medical Glove toPermeation by chemotherapyDrugs. | A powder-free patientexamination glove is adisposable device intended formedical purposes that is wornon the examiners hand or fingerto prevent contaminationbetween patient and examiner.Additionally, the gloves weretested for use withchemotherapy drugs inaccordance with ASTM D6978-05 Standard Practice forAssessment of Medical Glove toPermeation by chemotherapyDrugs. | Same |
| Labeling | N/A | There are no special labelingclaims. Does not claimhypoallergenic on label | There are no special labelingclaims. Does not claimhypoallergenic on label | Same |
| RegulationNumber | N/A | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Materials | N/A | Nitrile | Nitrile | Same |
| Color | N/A | Purple | Purple | Same |
| Textures fingers | N/A | Yes | Yes | Same |
| DesignConfigurations | ASTMD6319-10 | Extra-SmallSmallMediumLargeExtra-Large | Extra-SmallSmallMediumLargeExtra-Large | Same |
| DimensionsLength | ASTMD6319-10 | All sizes comply with lengthdimensions | All sizes comply with lengthdimensions | Same |
| DimensionsWidth | ASTMD6319-10 | All sizes comply with widthdimensions | All sizes comply with widthdimensions | Same |
| DimensionsThickness | ASTMD6319-10 | All sizes comply with thicknessdimensions | All sizes comply with thicknessdimensions | Same |
| DeviceCharacteristics | TestStandard | Proposed Device | Predicate DeviceK992162 | ComparisonAnalysis |
| PhysicalProperties -Tensile Strength | ASTMD6319-10 | Complies with ASTMD6319-10 both before andafter accelerated aging | Complies with ASTMD6319-10 both before andafter accelerated aging | Same |
| PhysicalProperties -Elongation | ASTMD6319-10 | Complies with ASTMD6319-10 both before andafter accelerated aging | Complies with ASTMD6319-10 both before andafter accelerated aging | Same |
| Freedom fromHoles | ASTMD6319-10by D5151-06 | Pass | Pass | Same |
| Powder FreeDesignation | ASTMD6319-10byD6124-06 | Less than 2.0 mg per glove;Pass | Less than 2.0 mg per glove;Pass | Same |
| Biocompatibility | ISO 10993-10:2010Reapproved2014 | Under conditions of the test,Not a skin irritant | Under conditions of the testNot a skin irritant | Same |
| ISO 10993-10:2010Reapproved2014 | Under conditions of the test,Not a skin sensitizer | Under conditions of the test,Not a skin sensitizer | Same | |
| ISO 10993-11:2006Reapproved2010 | Under conditions of the testDoes not causesystemic toxicity | Under conditions of the testDoes not causesystemic toxicity | Same | |
| Prescription vs.ОТС | N/A | ОТС | ОТС | Same |
| Sterile vs.Non-sterile | N/A | Non-Sterile | Non-Sterile | Same |
| Single Use | N/A | Yes | Yes | Same |
| Tested for usewithChemotherapyDrugs | ASTMD6978-05 | Please note: Carmustine andThioTEPA have extremely lowbreakthrough times of lessthan 30 minutes | Please note: Carmustine andThioTEPA have extremely lowbreakthrough times of lessthan 30 minutes | Same |
| Warning | N/A | WARNING: Not for Use with:Carmustine, ThioTEPA | WARNING: Not for Use with:Carmustine, ThioTEPA | Same |
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Part 10. Executive Summary
Comparison of Proposed Device to Predicate Device (pg. 2 of 2)
{9}------------------------------------------------
9.0 Conclusion
Based on intended uses, technological characteristics and non-clinical performance data, the subject device BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is substantially equivalent to the predicate device K992162 - Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim.
The subject device meets the requirements of ASTM D 6319- 10 standards as well as applicable 21 CFR and meets FDA recognized, physical properties requirements, pinhole requirements, powder free requirements, resistance to permeation by chemotherapy drugs testing, biocompatibility studies and labeling requirements presented in this document.
There are no safety or efficacy issues or new claims different from the "substantially equivalent" predicate.
Based on the complete list of non-clinical tests, biological safety studies, labeling, intended use, materials, and processes of manufacture, the subject device herein proposed 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.