TOP FEEL

CONDOM, SMOOTH

Intro

Details

Material

100% Natural High Grade Rubber Latex

Type

Latex Male Condom

Colour

Natural, Green, Pink, Purple, Red, Yellow

Flavour

Apple, Banana, Grape, Orange, Strawberry, Vanilla

Design

Smooth Designed, Beaded & Teat Ended

Lubricant

Non Spermicidal

Sterilization

Non Sterile

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

Application

For sexual intercourse usage, to prevent any possible pregnancy or any other sexually transmittable infections [STIs] or diseases

Benefits

1. Easy-fit shape for extra comfort

2. Made with Natural High Quality Rubber Latex for ultimate comfort & protection

3. Silicone-based lubricant for smoother feel

4. 100% Electronically tested

5. Reduced risk of pregnancy and protection from STIs

Quality Standards

1. Compliance to ASTM D3492-16, ISO 4074:2015 and WHO/UNFPA standards

2. Manufactured under ISO9001:2015 and ISO13485:2016 Quality Management System

Top Glove welcomes any inquiry on ordering OEM condoms. To know more about ordering OEM condoms services, contact us at [email protected] Our sales team will contact you with more details.

Create your own brands, customized packing, personalized condoms, only at Top Glove.

Physical Dimension

Dimension Standard

Length (mm)

Min 180

Palm Width (mm)

52 ± 2
53 ± 2

Thickness:
Single Wall (mm)

0.07 ± 0.01
(2.8mil ± 0.4)

Bursting Pressure And Volume

Description Standard

Burst Pressure (kPa)

Min 1.0

Burst Volume (L)

Min 18.0

Lubricant Quantity

Description Standard

Lubricant Quantity
(Including Powder)

550±150

Product Safety Conformance

CHEMICAL RESIDUE TESTED Pass

Purpose: To ensure the gloves are free from any chemical substances and safe to use.

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

Remark: Applicable to selected product. Please liaise with our representative for further details.

BIOCOMPATIBILITY TESTED Pass

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

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

Biocompatibility Test 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


Remark: Applicable to selected product. Please liaise with our representative for further details.

NITROSAMINE TESTED Pass

To test the carcinogenic potential of chemical substances in condom products.

Chemical Test (s) 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

BIOBURDEN TESTED Pass

To test the numbers of bacterial living on the glove’s surface that has not been sterilized.

Bioburden  Test Result
PASSES

Remark: Applicable to selected products. Please liaise with our representative for further details.

CLINICAL EVALUATION TESTED Pass

To test the efficiency and safety of glove usage.

Clinical Evaluation  Test Result
PASSES

Remark: Applicable to selected products. Please liaise with our representative for further details.

ACUTE SYSTEMIC TOXICITY TESTED Pass

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
Not a potential toxic agent under condition of the study

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