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510(k) Data Aggregation
K Number
K210330Device Name
Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
Manufacturer
WRP Asia Pacific SDN BHD
Date Cleared
2022-03-04
(393 days)
Product Code
LZA, LZC, ODO
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 Fentany] Citrate per ASTM D6978-05 (Re-approved 2013) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile, Tested for Fentanyl Resistance meet all requirements of ASTM D6319, ASTM D6978, and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile, a synthetic rubber. 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.
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K Number
K203030Device Name
POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Manufacturer
WRP ASIA PACIFIC SDN BHD
Date Cleared
2021-06-11
(252 days)
Product Code
KGO, LZC
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 | Concentration | Average Breakthrough Detection Time (Minutes) |
|-----------------------------------------|---------------|-----------------------------------------------|
| <b>*</b> Carmustine (BCNU) (3.3 mg/ml) | | 27.3 |
| Cisplatin (1.0 mg/ml) | | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | | > 240 |
| Dacarbazine (10.0 mg/ml) | | > 240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | | > 240 |
| Etoposide (20.0 mg/ml) | | > 240 |
| Fluorouracil (50.0 mg/ml) | | > 240 |
| Ifosfamide (50.0 mg/ml) | | > 240 |
| Methotrexate (25.0 mg/ml) | | > 240 |
| Mitomycin C (0.5 mg/ml) | | > 240 |
| Mitoxantrone (2.0 mg/ml) | | > 240 |
| Paclitaxel (6.0 mg/ml) | | > 240 |
| <b>*</b> ThioTepa (10.0 mg/ml) | | 26.9 |
| Vincristine Sulfate (1.0 mg/ml) | | > 240 |
*WARNING: Do not use Carmustine and ThioTepa.
Device Description
Not Found
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K Number
K192635Device Name
Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)
Manufacturer
WRP ASIA PACIFIC SDN BHD
Date Cleared
2020-01-17
(116 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 Nitrile Patient Examination Glove, Non-Sterile (Orange) 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
K161823Device Name
Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs
Manufacturer
WRP ASIA PACIFIC SDN BHD
Date Cleared
2017-01-23
(206 days)
Product Code
KGO, LZC
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 surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
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.
Carmustine (BCNU) 3.3mg/ml 30.4
Cisplatin 1.0mg/ml > 240
Cyclophosphamide (Cytoxan) 20.0mg/ml > 240
Dacarbazine 10.0mg/ml > 240
Doxorubicin Hydrochloride 2.0mg/ml > 240
Etoposide (Toposar) 20.0mg/ml > 240
Fluorouracil 50.0mg/ml > 240
Ifosfamide 50.0mg/ml > 240
Mitoxantrone 2.0mg/ml > 240
Paclitaxel (Taxol) 6.0mg/ml > 240
Thiotepa 10.0mg/ml 59.0
Vincristine Sulfate 1.0mg/ml > 240
CAUTION: Testing showed an average breakthrough time of 30.4 minutes for Carmustine and an average breakthrough time of 59.0 minutes for Thiotepa.
Device Description
Powder Free Nitrile Surgical Glove, Sterile meets all the requirements of ASTM standard D3577-09, D6978-05 and FDA 21 CFR 878.4460.
The powder free nitrile surgical glove 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 with ease without using any lubricant such as powder on the glove surface. The glove is hand specific. The physical properties of glove i.e. tensile strength meet ASTM standard D3577-09.
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