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510(k) Data Aggregation
K Number
K233990Device Name
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)
Manufacturer
Shandong Xingyu Gloves Co., Ltd.
Date Cleared
2024-04-01
(105 days)
Product Code
LZA, LZC, OPJ, QDO
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Shandong Xingyu Gloves Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitrile Disposable Examination Glove, Tested for Use with Chemotherapy Drugs and Fentanyl 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.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.
The tested chemotherapy drugs are:
Chemotherapy drug Concentration Minimum Breakthrough Detection Time
Bleomycin sulfate (15.0 mg/ml 15,000 ppm) >240 min
Carboplatin (10.0 mg/ml 10,000 ppm) >240 min
Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 13.2
Cisplatin (1.0 mg/mL 1,000 ppm) >240 min
Cyclophosphamide (20.0 mg/mL 20,000 ppm) >240 min
Cytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) >240 min
Dacarbazine (10.0 mg/mL 10.000 ppm) >240 min
Doxorubicin HCL (2.0 mg/mL 2,000 ppm) >240 min
Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) >240 min
Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) >240 min
Idarubicin (1.0 mg/ml 1.000 ppm) >240 min
Ifosfamide (50.0 mg/mL 50,000 ppm) >240 min
Mechlorethamine HCL (1.0 mg/ml 1,000 ppm) >240 min
Methotrexate (25.0 mg/mL 25,000 ppm) >240 min
Mitomycin C (0.5 mg/mL 500 ppm) >240 min
Mitoxantrone HCL (2.0 mg/mL 2.000 ppm >240 min
Paclitaxel (6.0 mg/mL 6.000 ppm) >240 min
Thiotepa (10.0 mg/mL 10,000 ppm) 13.1
Vincristine Sulfate (1.0 mg/mL 1,000 ppm >240 min
The tested non-chemotherapy drugs are:
Fentanyl Citrate Injection (100 mcg/2mL) >240 min
MESNA (100.0 mg/mL 100,000 ppm) >240 min
Trisenox (1.0 mg/ml 1,000 ppm) >240 min
Note: Carmustine and Thiotepa have extremely low permeation times of 13.2 and 13.1 minutes respectively.
Warning: Do Not Use with Carmustine, Thiotepa
Device Description
The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in six sizes, extra small, small, medium, large, extra-large and extra extra-large, packed in a paper box.
The gloves are designed and manufactured in accordance with the ASTM D6319 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.
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K Number
K221272Device Name
Medical Face Mask
Manufacturer
Shandong Xingyu Gloves Co., Ltd.
Date Cleared
2022-06-28
(57 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Shandong Xingyu Gloves Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
Device Description
The Proposed Device Medical Face Mask (Model: M001, M2002, M3001, M3002) are available in blue and black colors, and flat pleated type mask, utilizing ear loops way for wearing, and it has Nose clips design for fitting the face mask around the nose. The proposed device(s) submitted meet both the performance requirements of level 2 and 3 specified in ASTM F2100-19. Level 2 blue mask is model number M2001; Level 2 black mask is model number M2002; Level 3 blue mask is model number M3001; Level 3 black mask is model number M3002; The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Polyester and Spandex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Metal Core Plastic (Iron wire & Polypropylene). The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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K Number
K171615Device Name
Xingyu Nitrile Powder Free Patient Examination Gloves, White color
Manufacturer
Shandong Xingyu Gloves Co., Ltd
Date Cleared
2017-07-31
(60 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Shandong Xingyu Gloves Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Xingyu Powder Free Nittile Patient Examination Gloves, White Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner
Device Description
Nitrile films form a barrier to prevent contamination between patient and examiner. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Nitrile glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D6319-10(Reapproved 2015) and ASTM D5151-06(Reapproved 2015).
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K Number
K171616Device Name
Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color
Manufacturer
Shandong Xingyu Gloves Co., Ltd
Date Cleared
2017-07-20
(49 days)
Product Code
LZA
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Shandong Xingyu Gloves Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Xing Yu Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile 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
Nitrile films form a barrier to prevent contamination between patient and examiner. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Nitrile glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151.
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