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Found 12 results
510(k) Data Aggregation
K Number
K230079Device Name
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential
Manufacturer
Ansell Healthcare Products, LLC.
Date Cleared
2023-08-23
(225 days)
Product Code
KGO, LZC, OPJ
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Ansell Healthcare Products, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These surgical gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with chemotherapy drugs, have low dermatitis potential, and are nonpyrogenic. 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
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber, are white in color, and are available in sizes 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy.
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K Number
K213289Device Name
Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs
Manufacturer
Ansell Healthcare Products, LLC
Date Cleared
2023-05-26
(602 days)
Product Code
KGO, LZC, OPJ
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Ansell Healthcare Products, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A powder-free surgeons' glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove system was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy testing was carried out on the system as a whole, including both the under-glove together. Please note that the following drugs have extremely low permeation times: 3.0 minutes and Thiotepa: 67.0 minutes. Warning: Do not use with Carmustine or Thiotepa.
Device Description
Gammex® Pl Plus Glove-in-Glove™ System tested for use with Chemotherapy Drugs is a sterile and disposable device. This glove system ismade of synthetic polyisoprene rubber. Gammex® Pl Plus Glove- in-Glove™ System Tested for Use with Chemotherapy Drugs is comprised of a single-use, sterile, white outer glove, which is a disposable, powder-free surgical glove made from synthetic polyisoprene and a single-use, sterile, green underglove which is a disposable, powder-free surgical glove made from syntheticpolyisoprene. The Gammex® Pl PlusGlove-in-Glove™ system Testedfor Use with Chemotherapy Drugs is comprised of the underglove being mechanically inserted into the outer glove prior to packing and sterilization. There is no adhesive present between the two gloves. This results in quick double gloving with only one donning event.
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K Number
K190018Device Name
Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
Manufacturer
Ansell Healthcare Products, LLC.
Date Cleared
2019-05-23
(139 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Ansell Healthcare Products, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Gammex Non Latex PI White Surgical Gloves Tested for Use with Chemotherapy Drugs are 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.
Device Description
Gammex Non Latex Pl White Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy. Ansell has performed independent laboratory testing on the already cleared device to support a labeling modification for the subject device that the gloves are safe and ling chemotherapy agents
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K Number
K182948Device Name
Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
Manufacturer
Ansell Healthcare Products, LLC.
Date Cleared
2019-03-22
(150 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
Ansell Healthcare Products, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Gammex PI Hybrid Surgical Gloves are 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.
Device Description
Gammex Pl Hybrid Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic rubber blend of polyisoprene and polychoroprene. A polyurethane polymer coating is applied to the inner surface of the glove to make donning eay. Ansell has performed independent laboratory testing on the already cleared device to support a labeling modification for the subject device that the gloves are safe and effective for handling chemotherapy agents.
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K Number
K163107Device Name
Lifestyles Zero Lubricated Latex Male Condom
Manufacturer
ANSELL HEALTHCARE PRODUCTS, LLC
Date Cleared
2017-01-23
(77 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
ANSELL HEALTHCARE PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lifestyles Zero Lubricated Latex Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
Device Description
This condom is a single use and non-sterile device intended for in home use by a consumer. The condom is made of a natural rubber latex sheath, which completely covers the penis with closely fitted membrane. The condom provides a physical barrier to fluids which helps reduce the risk of pregnancy and the transmission of sexually-transmitted infections. The device is a straight walled, cylindrical, lubricated condom with a reservoir tip. Condom dimensions are length 180+/- 10 mm, width 52±2mm, and thickness 0.045+/-0.005 mm. The condom is designed to conform to the requirements of ASTM D3492:2015 - Standard Specification for Rubber Contraceptives (Male Condoms).
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K Number
K160399Device Name
Skyn Original Polyisoprene Lubricated Male Condom
Manufacturer
Ansell Healthcare Products, LLC
Date Cleared
2016-07-25
(164 days)
Product Code
MOL
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Ansell Healthcare Products, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Skyn Original Polyisoprene Lubricated Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
Device Description
The Skyn Original Polyisoprene Lubricated Male Condom is a male contraceptive and prophylactic device made from synthetic rubber Polyisoprene latex with a lubricant coating containing silicone gel with fragrance oil. Fragrance oil acts as a masking agent to minimize odor originated from condom substrate. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length >180mm, width 53±2mm, and thickness 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 5-year shelf-life.
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K Number
K151694Device Name
Gammex PI Hybrid Surgical Gloves
Manufacturer
ANSELL HEALTHCARE PRODUCTS, LLC
Date Cleared
2016-03-09
(260 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ANSELL HEALTHCARE PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Gammex PI Hybrid Surgical Glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.
Device Description
The subject device is single-use disposable powder-free surgical glove that is supplied sterile and made of synthetic rubber blend of polyisoprene and neoprene.
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K Number
K122476Device Name
LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT
Manufacturer
ANSELL HEALTHCARE PRODUCTS, LLC
Date Cleared
2013-03-07
(205 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
ANSELL HEALTHCARE PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LifeStyles® Smooth™ 2-in-1 Massage & Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Device Description
LifeStyles® Smooth™ 2-in-1 Massage & Lubricant is a non-sterile, water-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a non-staining, non-sticky, biocompatible gel-like liquid, with a strawberry aroma, that is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The product is provided in a plastic pump dispenser
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K Number
K122054Device Name
LIFESTYLES NATURAL PERSONAL LUBRICANT
Manufacturer
ANSELL HEALTHCARE PRODUCTS, LLC
Date Cleared
2013-02-14
(216 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
ANSELL HEALTHCARE PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LifeStyles® Natural Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Device Description
LifeStyles® Natural Personal Lubricant is a non-sterile, water-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a non-staining, long-lasting, biocompatible gel-like liquid that is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The provided in a plastic pump dispenser.
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K Number
K103714Device Name
ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA
Manufacturer
ANSELL HEALTHCARE PRODUCTS, LLC
Date Cleared
2011-07-07
(198 days)
Product Code
KGO
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
ANSELL HEALTHCARE PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has been tested for use with chemotherapy drugs.
Device Description
The Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim <50µg/dm2 per Glove of Extractable Protein, is a disposable device made of natural latex rubber that is intended to be worn by operating room personnel to protect a surgical wound from contamination, and is tested for use with chemotherapy drugs.
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