100 Gloves Latex Powder-Free (Top Gloves)

9,50

Examination Glove is a disposable device intended for medical purposes that are worn on the examiner’s hand to prevent contamination between the patient and examiner.

  • European Countries: Class I Directive MDD 93/42/EEC
  • United States of America (USA) : Class I with approved 21.CFR.820 FDA 510(K)

FUNCTIONAL BENEFITS:

  • Protection from unwanted or dangerous substances
  • Easy donning and helps prevent roll back
  • Softness provides superior comfort and natural fit
  • Beaded cuff makes donning easy
  • Ambidextrous and straight fingers

QUALITY STANDARDS:

  • Conforms to ASTM D3578 and EN 455 Standards
  • Manufactured under QSR (GMP), ISO 9001:2015 and ISO 13485:2016 Quality Management System

GLOVE SIZES:

  • Small, Medium, Large

 

 

PRODUCT SAFETY CONFORMANCE:

1.1) BIOCOMPATIBILITY TESTED

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

1.2) VIRAL PENETRATION TESTED

Reference: ASTM F1671 – Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood – Borne Pathogens Using Phi-X 174 Bacteriophage Penetration as a Test System

Purpose: To test the barrier protection of the gloves from the passages of the viruses

Viral Penetration Test Results
Passes

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

1.3) HEAVY METAL TESTED

Purpose: To ensure gloves are free from heavy metals substances

Chemical Test (s) Test Results (mg/kg)
Cadmium (Cd) Not Detected
Lead (Pb) Not Detected
Mercury (Hg) Not Detected
Arsenic (As) Not Detected
Antimony (Sb) Not Detected
Tin (Sin) Not Detected

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

1.4) CHEMICAL RESIDUE TESTED

Purpose: To ensure gloves are free from any chemical substances

Chemical Test (s) Test Results (μg/g)
Butylated Hydroxyanisole (BHA) Not Detected
Butylated Hydroxytoluene (BHT) 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

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

 

Brand MUMU is from manufacturer Top Gloves:

Full brochure http://www.cmddental.be/TG_Latex_Glove.pdf

Effacer
UGS : ND Catégorie :

Description

Examination Glove is a disposable device intended for medical purposes that are worn on the examiner’s hand to prevent contamination between the patient and examiner.

  • European Countries: Class I MDD Directive 93/42 / EEC
  • United States of America (USA): Class I with approved 21.CFR.820 FDA 510 (K)

FUNCTIONAL BENEFITS:

  • Protection from unwanted or dangerous substances
  • Easy donning and helps prevent roll back
  • Softness provides superior comfort and natural fit
  • Beaded cuff makes donning easy
  • Ambidextrous and straight fingers

QUALITY STANDARDS:

  • Conforms to ASTM D3578 and EN 455 Standards
  • Manufactured under QSR (GMP), ISO 9001: 2015 and ISO 13485: 2016 Quality Management System

GLOVE SIZES:

  • Small, Medium, Large

 

 

PRODUCT SAFETY CONFORMANCE:

1.1) BIOCOMPATIBILITY TESTED

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

1.2) VIRAL PENETRATION TESTED

Reference: ASTM F1671 – Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood – Borne Pathogens Using Phi-X 174 Bacteriophage Penetration as a Test System

Purpose: To test the barrier protection of the gloves from the passages of the viruses

Viral Penetration Test Results
Passes

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

1.3) HEAVY METAL TESTED

Purpose: To ensure gloves are free from heavy metals substances

Chemical Test (s) Test Results (mg/kg)
Cadmium (Cd) Not Detected
Lead (Pb) Not Detected
Mercury (Hg) Not Detected
Arsenic (As) Not Detected
Antimony (Sb) Not Detected
Tin (Sin) Not Detected

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

1.4) CHEMICAL RESIDUE TESTED

Purpose: To ensure gloves are free from any chemical substances

Chemical Test (s) Test Results (μg/g)
Butylated Hydroxyanisole (BHA) Not Detected
Butylated Hydroxytoluene (BHT) 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

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

 

Brand MUMU is from manufacturer Top Gloves:

Full brochure http://www.cmddental.be/TG_Latex_Glove.pdf