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510(k) Data Aggregation
K Number
K232079Device Name
Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
Manufacturer
WRP Asia Pacific Sdn. Bhd.
Date Cleared
2024-03-28
(259 days)
Product Code
KGO, LZC, OPJ, QDO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
WRP Asia Pacific Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.
These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
This is a disposable natural rubber surgical glove that is tested for use with chemotherapy drugs and fentanyl resistance. The glove is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 8½ and 9.
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K Number
K232538Device Name
DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
Manufacturer
WRP Asia Pacific Sdn. Bhd.
Date Cleared
2023-11-17
(87 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WRP Asia Pacific Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A 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. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl meets all requirements of ASTM standard D6319-19. The powder free examination glove is manufactured from synthetic rubber nitrile. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D6319. Device is intended for single use and nonsterile. The powder free examination glove, non-sterile is supplied in the following sizes: S, M, L, XL and XXL. This glove is green (inner) and white (outer) in color and powder free.
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K Number
K230578Device Name
Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
Manufacturer
WRP Asia Pacific Sdn. Bhd.
Date Cleared
2023-08-31
(183 days)
Product Code
KGO, LZC, OPJ, QDO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
WRP Asia Pacific Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug Permeation The following chemicals have been tested with these gloves. (Table of chemotherapy drugs and breakthrough times) Fentanyl Citrate Injection 100mcg/2mL No breakthrough up to 240 minutes
Device Description
This is a disposable polyisoprene surqical glove that is tested for use with chemotherapy drugs and fentanyl. The device is composed of two layers which are not attached in the fingers or palm/back of hand region, but are attached in the cuff area. The outer layer of the glove is white and the inner layer is green. The glove is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 81/2 and 9, and is provided sterile. No shelf life is claimed.
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K Number
K222058Device Name
Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
Manufacturer
WRP Asia Pacific SDN. BHD.
Date Cleared
2022-10-22
(102 days)
Product Code
KGO, LZC, OPJ, QDO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
WRP Asia Pacific SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl Citrate.
Device Description
Powder Free Polyisoprene Surgical Glove, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistance meets all the requirements of ASTM standard D3577, ASTM D6978-05 and FDA 21 CFR 878.4460. The powder free polyisoprene surgical glove is manufactured from 100% synthetic polyisoprene latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is hand specific. The physical properties of qlove, i.e., tensile strength meets ASTM standard D3577. Device is intended for single use. The powder free polyisoprene surgical glove, sterile is supplied in the following sizes: 5½, 6, 6½, 7, 7½, 8, 8½ and 9. This glove comes in natural color and powder free.
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K Number
K211601Device Name
Powder Free Latex Examination Glove, Non-Sterile
Manufacturer
WRP Asia Pacific SDN. BHD.
Date Cleared
2022-08-22
(455 days)
Product Code
LYY
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WRP Asia Pacific SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
The powder free latex examination glove is manufactured from natural rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D3578. Device is intended for single use and nonsterile. The powder free latex examination glove, non-sterile is supplied in the following sizes: XS, S, M, L and XL. This qlove is natural in color is added) and powder free.
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K Number
K161422Device Name
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Manufacturer
WRP ASIA PACIFIC SDN. BHD.
Date Cleared
2016-10-20
(150 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WRP ASIA PACIFIC SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A 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.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Device Description
Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile the meets all requirements of ASTM standard D6319-10, D6978-05 and FDA 21 CFR 880.6250.
The powder free nitrile examination qlove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D6319-10.
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K Number
K141982Device Name
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Manufacturer
WRP ASIA PACIFIC SDN. BHD.
Date Cleared
2015-02-05
(199 days)
Product Code
LZC, LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WRP ASIA PACIFIC SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A 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.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|----------------------------------------|---------------|----------------------------------------|
| Flourouracil (Adrucil) | 50.0mg/ml | > 240 |
| Etopside (Toposar) | 20.0mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 |
| *Carmustine (BCNU) | 3.3mg/ml | 15.0 |
| *Thiotepa | 10.0mg/ml | 2.0 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 |
| Doxorubicin Hydrochloride (Adriamycin) | 2.0mg/ml | > 240 |
| Dacarbazine | 10.0mg/ml | > 240 |
| Cisplatin | 1.0mg/ml | > 240 |
| Ifosfamide | 50.0mg/ml | > 240 |
| Mitoxantrone | 2.0mg/ml | > 240 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |
* Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) : 15 minutes and Thiotepa : 2 minutes
Device Description
Powder Free Blue Nitrile Patient Examination Glove, Non-Sterile meets all the requirements of ASTM standard D6319-10, D6978-05 and FDA 21 CFR 880.6250.
The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the qlove surface. The qlove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meets ASTM standard D6319-10.
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K Number
K133168Device Name
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
Manufacturer
WRP ASIA PACIFIC SDN. BHD.
Date Cleared
2014-08-07
(294 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WRP ASIA PACIFIC SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A 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.
Device Description
The Dermagrip powder free blue nitrile patient examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the qloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.
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K Number
K132484Device Name
DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
Manufacturer
WRP ASIA PACIFIC SDN. BHD.
Date Cleared
2013-12-13
(127 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WRP ASIA PACIFIC SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A 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.
Device Description
Powder Free Black Nitrile Patient Examination Glove, Non-Sterile meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.
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K Number
K083408Device Name
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Manufacturer
WRP ASIA PACIFIC SDN. BHD.
Date Cleared
2009-07-31
(255 days)
Product Code
LZC, LYY, LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
WRP ASIA PACIFIC SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The powder free chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows [Carmustine (BiCNU). Thio-Tepa. Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide and Paclitaxel].
WARNING: DO NOT USE THESE GLOVES WITH THIO-TEPA CAUTION: Testing showed an average breakthrough time of less than 60 minutes with Carmustine.
Device Description
Powder Free Blue Nitrile Patient Examination Gloves, Tested for use with Chemotherapy Drugs meet all the requirements of ASTM standard D6978-05, D5712-05e1 and FDA 21 CFR 880.6250.
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