(129 days)
Not Found
No
The device is a physical barrier (examination glove) and the description focuses on material properties and resistance to chemicals, with no mention of computational analysis or learning algorithms.
No.
The device is a nitrile examination glove designed to prevent contamination between patient and examiner, not to provide therapy.
No
Explanation: This device is a nitrile examination glove intended as a barrier to prevent contamination, not to diagnose a condition or disease.
No
The device description clearly states it is a physical glove made from nitrile compound, which is a hardware component. The testing described also focuses on physical properties and resistance to chemicals, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during medical procedures.
- Device Description: The device is described as a "Purple Nitrile Examination glove." This is a physical barrier.
- Lack of Diagnostic Function: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such diagnostic function. Its purpose is to prevent the transfer of substances.
- Testing Performed: The testing described (ASTM D6319, ASTM D6978, ISO 10993) focuses on the physical properties of the glove as a barrier, its resistance to chemotherapy drugs, and its biocompatibility. These are relevant tests for a protective medical device, not an IVD.
The fact that it is tested for use with chemotherapy drugs and provides information on breakthrough times relates to its function as a protective barrier against these substances, not as a diagnostic tool.
N/A
Intended Use / Indications for Use
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 :
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
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger (worn on examiner's hand or finger)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed per ASTM D6319: 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
- 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.
Both the proposed device and the predicate were tested for use with chemotherapy drugs per:
- ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
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.
Key results: 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.
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.
K992162 Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim
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 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
3
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)
| Device
Characteristics | Test
Standard | Proposed Device | Predicate Device
K992162 | Comparison
Analysis |
|-------------------------------------------------|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Trade Name | N/A | Brightway Brand Nitrile
Examination Gloves, Powder
Free, [Purple] Tested for Use
with Chemotherapy Drugs | Safeskin Purple Powder-Free
Nitrile Examination Gloves Tested
for 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 patient
examination glove is a
disposable device intended for
medical purposes that is worn
on the examiners hand or finger
to prevent contamination
between patient and examiner.
Additionally, the gloves were
tested for use with
chemotherapy drugs in
accordance with ASTM D6978-
05 Standard Practice for
Assessment of Medical Glove to
Permeation by chemotherapy
Drugs. | A powder-free patient
examination glove is a
disposable device intended for
medical purposes that is worn
on the examiners hand or finger
to prevent contamination
between patient and examiner.
Additionally, the gloves were
tested for use with
chemotherapy drugs in
accordance with ASTM D6978-
05 Standard Practice for
Assessment of Medical Glove to
Permeation by chemotherapy
Drugs. | Same |
| Labeling | N/A | There are no special labeling
claims. Does not claim
hypoallergenic on label | There are no special labeling
claims. Does not claim
hypoallergenic on label | Same |
| Regulation
Number | 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 |
| Design
Configurations | ASTM
D6319-10 | Extra-Small
Small
Medium
Large
Extra-Large | Extra-Small
Small
Medium
Large
Extra-Large | Same |
| Dimensions
Length | ASTM
D6319-10 | All sizes comply with length
dimensions | All sizes comply with length
dimensions | Same |
| Dimensions
Width | ASTM
D6319-10 | All sizes comply with width
dimensions | All sizes comply with width
dimensions | Same |
| Dimensions
Thickness | ASTM
D6319-10 | All sizes comply with thickness
dimensions | All sizes comply with thickness
dimensions | Same |
| Device
Characteristics | Test
Standard | Proposed Device | Predicate Device
K992162 | Comparison
Analysis |
| Physical
Properties -
Tensile Strength | ASTM
D6319-10 | Complies with ASTM
D6319-10 both before and
after accelerated aging | Complies with ASTM
D6319-10 both before and
after accelerated aging | Same |
| Physical
Properties -
Elongation | ASTM
D6319-10 | Complies with ASTM
D6319-10 both before and
after accelerated aging | Complies with ASTM
D6319-10 both before and
after accelerated aging | Same |
| Freedom from
Holes | ASTM
D6319-10
by D5151-
06 | Pass | Pass | Same |
| Powder Free
Designation | ASTM
D6319-10
by
D6124-06 | Less than 2.0 mg per glove;
Pass | Less than 2.0 mg per glove;
Pass | Same |
| Biocompatibility | ISO 10993-
10:2010
Reapproved
2014 | Under conditions of the test,
Not a skin irritant | Under conditions of the test
Not a skin irritant | Same |
| | ISO 10993-
10:2010
Reapproved
2014 | Under conditions of the test,
Not a skin sensitizer | Under conditions of the test,
Not a skin sensitizer | Same |
| | ISO 10993-
11:2006
Reapproved
2010 | Under conditions of the test
Does not cause
systemic toxicity | Under conditions of the test
Does not cause
systemic 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 use
with
Chemotherapy
Drugs | ASTM
D6978-05 | Please note: Carmustine and
ThioTEPA have extremely low
breakthrough times of less
than 30 minutes | Please note: Carmustine and
ThioTEPA have extremely low
breakthrough times of less
than 30 minutes | Same |
| Warning | N/A | WARNING: Not for Use with:
Carmustine, ThioTEPA | WARNING: Not for Use with:
Carmustine, ThioTEPA | Same |
8
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.