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510(k) Data Aggregation
K Number
K250342Device Name
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
Manufacturer
Encompass Industries Sdn. Bhd.
Date Cleared
2025-07-08
(152 days)
Product Code
LZA, LZC, OPC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Encompass Industries Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K220609Device Name
Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)
Manufacturer
Encompass Industries Sdn. Bhd.
Date Cleared
2022-05-27
(86 days)
Product Code
LZA, LZC
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Encompass Industries Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, the glove was tested for chemotherapy drugs permeation.
Device Description
The proposed Powder-Free Nitrile Examination Glove (White, Blue, Black, Orange and Green Color) Tested for use with Chemotherapy Drugs and Fentanyl is a disposable device intended for over-the-counter use and is provided powder-free and non-sterile. These patient examination gloves are formulated using Nitrile. The patient examination gloves are not made with natural rubber latex.
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K Number
K183562Device Name
Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs
Manufacturer
Encompass Industries Sdn. Bhd.
Date Cleared
2019-10-23
(307 days)
Product Code
LZC, LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Encompass Industries Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
In addition, the glove was tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
The following chemotherapy drugs have been tested with the white glove:
Cyclophosphamide (Cytoxan) 20.0mg/ml > 240
Doxorubicin Hydrochloride 2.0mg/ml > 240
Etoposide (Toposar) 20.0mg/ml > 240
Fluorouracil 50.0mg/ml > 240
Paclitaxel (Taxol) 6.0mg/ml > 240
Cisplatin 1.0mg/ml > 240
Dacarbazine (DTIC) 10.0mg/ml > 240
Carmustine (BCNU) 3.3mg/ml 11.2
Thiotepa (THT) 10.0mg/ml 25.2
*Please note that the following 2 drugs have extremely low permeation times:
1. Carmustine: 11.2 minutes
2. Thiotepa: 25.2 minutes
Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT).
The following chemotherapy drugs have been tested with the blue glove:
Cyclophosphamide (Cytoxan) 20.0mg/ml > 240
Doxorubicin Hydrochloride 2.0mg/ml > 240
Etoposide (Toposar) 20.0mg/ml > 240
Fluorouracil 50.0mg/ml > 240
Paclitaxel (Taxol) 6.0mg/ml > 240
Cisplatin 1.0mg/ml > 240
Dacarbazine (DTIC) 10.0mg/ml > 240
Carmustine (BCNU) 3.3mg/ml 10.7
Thiotepa (THT) 10.0mg/ml 21.5
*Please note that the following 2 drugs have extremely low permeation times:
1. Carmustine: 10.7 minutes
2. Thiotepa: 21.5 minutes
Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT).
The following chemotherapy drugs have been tested with the black glove:
Cyclophosphamide (Cytoxan) 20.0mg/ml > 240
Doxorubicin Hydrochloride 2.0mg/ml > 240
Etoposide (Toposar) 20.0mg/ml > 240
Fluorouracil 50.0mg/ml > 240
Paclitaxel (Taxol) 6.0mg/ml > 240
Cisplatin 1.0mg/ml > 240
Dacarbazine (DTIC) 10.0mg/ml > 240
Carmustine (BCNU) 3.3mg/ml 11.0
Thiotepa (THT) 10.0mg/ml 11.1
*Please note that the following 2 drugs have extremely low permeation times:
1. Carmustine: 11.0 minutes
2. Thiotepa: 11.1 minutes
Warning: Do not use with Carmustine (BCNU) and Thiotepa (THT).
Device Description
Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs
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