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DOTTED CONDOM

Type
  • Latex Male Condom, Non-sterile
Material
  • 100% Natural High Grade Rubber Latex
Design & Features
  • Designed with dotted texture to intensify pleasure and increased sexual excitement
Lubricant
  • Non Spermicidal
Storage
  • The condom shall maintain their properties when in sealed pack and stored in a dry condition. Avoid direct sunlight
Shelf-life
  • 5 years from the date of manufacturing

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  • Easy-fit shape for extra comfort
  • Reduced risk of pregnancy and protection from STIs
  • Silicone-based lubricant for smoother feel
  • 100% Electronically tested
  • Made with Natural High Quality Rubber Latex for ultimate comfort & protection
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  • Conforms to ASTM D3492-16, ISO 4074:2015 and WHO/UNFPA 2013
  • Manufactured under ISO 9001:2015 and ISO 13485:2016 Quality Management System
 
Dimensions Top Feel
Length (mm) Min 180
Nominal Width (mm) 52 ± 2
Thickness (mm)
*Single Wall
0.07 ± 0.01
Property Top Feel
Burst Pressure (kPa)
Before Aging
After Aging

Min 1.0
Min 1.0
Burst Volume (L)
Before Aging
After Aging

Min 18.0
Min 18.0
Lubricant Quantity (mg/condom )
(Including Powder)

550 ± 150
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Reference: ISO 10993-10 (Test for Skin Irritation and Skin Sensitization)

Purpose: Biological evaluation for medical devices for irritation and delayed type hypersensitivity

Property Test Results
Primary Skin Irritation
Passes
Not a primary skin irritant under condition of the study
Skin Sensitization
Passes
Not a contact sensitizer under condition of the study

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Purpose: To ensure gloves are free from any chemical substances

Chemical Test Test Results (μg/g)
Butylated Hydroxyanisole (BHA) Not Detected
Butylated Hydroxytoluene (BHT) Not Detected
Diphenyl Thiourea (DPT) Not Detected
Zinc Mercaptobenzothiazole (ZMBT)/(MBT) Not Detected
Tetramethylthiuram Disulphide (TMTD) Not Detected
Zinc Dibutyldithiocarbamate (ZD8C) Not Detected
Zinc Diethyldithiocarbamate (ZDEC) Not Detected
Zinc Dimethyldithiocarbamate (ZDMC) Not Detected
Zinc Mercaptobenzimidazole (ZMBI) Not Detected
Zinc Pentamethyleneditithiocarbamate (ZPMC) Not Detected

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Purpose: To test the carcinogenic potential of chemical substances in condom products

Chemical Test Test Results (μg/g)
N-nitrosodimethylamine (NDMA) Not Detected
N-nitrosodiethylamine (NDEA) Not Detected
N-nitrosodipropylamine (NDPA) Not Detected
N-nitrosodibutylamine (NDBA) Not Detected
N-nitrosopiperidine (NPIP) Not Detected
N-nitrosopyrrolidine (NPYR) Not Detected
N-nitrosomorpholine (NMOR) Not Detected
N-nitrosodibenzylamine (NDBzA) Not Detected
N-nitroso-N-methyl-N-phenylamine (NMPhA) Not Detected
N- nitroso-N-ethyl-N-phenylamine (NEPha) Not Detected
N-nitrososodiisononylamine (NDiNA) Not Detected

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Purpose: To test the numbers of bacteria living on the condom's surface that has not been sterilized

Bioburden Test Results (ng/g)
Passes

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Purpose: To test efficiency and safety of condom product usage

Clinical Evaluation Test Results
Passes

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Purpose: To evaluate the adverse effect following an intraperitoneal administration of a single, multiple or continuous dose of test material within 24 hours

Acute Systemic Toxicity Test Results
Passes
Not a potential toxic agent under condition of the study
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