Product Details

  • Gloves compounded primarily from natural rubber latex (Type-1).
  • Creamy white to pale yellow in colour (Natural colour).
  • Free from dirt marks, oil stains, embedded foreign particles, coagulum, etc.
  • EO Sterilized.
  • Product conforms to IS 13422:1992 , ASTM D 3577:2019 , EN 455-1:2000 ,EN 455 2:2009+A2 : 2013 , EN 455-3:2006 and EN 455-4:2009 standard specifications.

  • Anatomically shaped medical gloves with the thumb positioned towards the palmar surface of the Index finger rather than laying flat.
  • Lightly powdered with modified absorbable Corn Starch USP .
  • The cuff shall fit closely without being constrictive and shall not roll back or ruckle while in use.
  • Anatomically shaped with micro rough surface in palm and finger area.
  • Products have shelf-life of 5 years from the date of manufacturing.
  • Each glove has non-detectable levels of chemical residue.
  • Sterilized by validated process cycle as per ISO 11135:2014.
  • Passes Viral Penetration test as per ASTM F 1671
  • The Sterility Assurance Level (SAL) is 10−6.
  • Biologically compatible as per ISO 10993-Part 5,7, 10 & 11.
  • Nontoxic, non-irritant and non-pyrogenic.

  • Gloves intended for use in surgical work and to be worn once and then discarded. The glove is worn on the hand of surgeon and healthcare personnel to prevent cross-contamination between healthcare personnel and patient’s body, fluids, waste or environment. The gloves are designed for transient use and are intended to be used in conjunction with invasive surgery.

  • Store the gloves in a cool, dry place and away from direct sunlight.
  • Sterile Gloves for single use only. Sterile until package is opened or damaged.
  • This product contains natural rubber latex which may cause allergic reactions including anaphylactic responses in some individuals.
  • After donning, remove powder by wiping gloves thoroughly with a sterile wet sponge, sterile wet towel, or other effective method.
  • Reuse of gloves may cause infection, allergic reactions, and poor barrier protection.
  • For transient use (normally intended for continuous use for less than 60 minutes).
  • Dispose after use as per hospital policies or country’s regulatory norms.

Size Length (mm) Palm Width (mm) Thickness ( in mm)
Cuff (Min) Palm (Min) Finger (Min )
Min Specification Standard SMR Standard SMR Standard SMR
5½ 250 70 ± 6 0.10 0.11 0.10 0.14 0.10 0.16
6 265 76 ± 6
6 ½ 83 ± 6
7 270 89 ± 6
7 ½ 95 ± 6
8 102 ± 6
8 ½ 280 108 ± 6
9 114 ± 6

2. Physical Properties

Characteristics Before Ageing After Ageing 70 ± 20 °C for 168 hrs.
ASTM D 3577:2019, IS 13422:1992
Tensile Strength (Mpa) min. 24 18
Ultimate Elongation (%) min. 750 560
Stress at 500% Elongation (Mpa) Max. 5 .5 NA
EN 455-2:2009+A2:2013
Minimum force at break 9.0 N 9.0 N
Aqueous extractable protein content
(As per standards ASTM D 3577:2019 & EN 455-3:2006)		 < 200 μg/dm² – Test method ASTM D 5712-15 (2020)
Powder content (As per standards ASTM D 3577:2019 & EN 455-3:2006) < 15 mg/dm² - Test method ASTM D 6124-06 (2017)
Sterilization (for sterile product) Ethylene Oxide
Sterility Shall pass Sterility test as per IP /USP / EN standards

Packing

Packing type:
1 Pair of gloves per inner wrapper.
1 inner wrapper per pouch.
50 pouches per inner box
500/ 400 pairs in an outer carton
based on customer requirements.

 Shall comply with standard packaging and customer
requirements
Labeling

Shall comply with regulatory requirement and customer requirements

3. Performance Requirements as per ASTM D 3577:2019 & EN 455-1; 2000, EN 455-2:2009+A2:2013 & EN 455-3: 2006

Sampling procedure:
ISO 2859 Part I

Sampling plan
i. General Inspection Level – For freedom from pinholes
ii. Special Inspection Level – For Physical Dimension and Physical Properties (Before ageing and after ageing)

Characteristics Inspection Level AQL
Freedom from holes G-1 0.65
Physical Dimensions S2 4.0
Physical Properties  S2 4.0
Extractable Protein Content N=3 NA
Powder amount N=3 NA
Sterility As per standard N/A

Product Details

  • Gloves compounded primarily from natural rubber latex (Type-1).
  • Powder-free gloves coated with a unique blend of polymer to provide excellent donning capability.
  • Creamy white to pale yellow in color (Natural color).
  • Free from dirt marks, oil stains, embedded foreign particles, coagulum, etc.
  • EO Sterilized.
  • Product conforms to IS 13422:1992 , ASTM D 3577:2019 , EN 455-1:2020 , EN 455-2:2009+A2 : 2013 , EN 455-3:2006 and EN 455-4:2009 standard specifications.

  • Anatomically shaped medical gloves with the thumb positioned towards the palmar surface of the index finger rather than laying flat.
  • The cuff shall fit closely without being constrictive, and it shall not roll back or ruckle while in use.
  • The physical properties, dimension and tensile strength of the material is as per European CE/USFDA standards (EN 455, ASTM D 3577 and IS 13422).
  • Anatomically shaped with micro rough surface in inner palm and in inner part of finger area which provides good grip at wrist and in curved fingers
  • Products have shelf-life of 5 years from the date of manufacturing.
  • Each glove has non-detectable levels of chemical residue.
  • Sterilized by validated process cycle (ISO 11135:2014).
  • Passes Viral Penetration test as per ASTM F 1671.
  • The Sterility Assurance Level (SAL) is 10⁻⁶.
  • Biologically compatible as per ISO 10993 Part 5, 7, 10 & 11.
  • Non-toxic and non- irritant.

  • Gloves intended for use in surgical work and to be worn once and then discarded. The glove is worn on the hand of surgeon and healthcare personnel to prevent cross contamination between healthcare personnel and patient’s body, fluids, waste or environment. The gloves are designed for transient use and are intended to be used in conjunction with invasive surgery.

  • Store the gloves in a cool, dry place and away from direct sunlight.
  • Sterile Gloves for single use only. Sterile until package is opened or damaged.
  • For transient use (normally intended for continuous use for less than 60 minutes)
  • This product contains natural rubber latex which may cause allergic reactions including anaphylactic responses in some individuals.
  • Reuse of gloves may cause infection, allergic reaction and poor barrier protection.
  • Dispose after use as per hospital policies or country’s regulatory norms.

Size Length (mm) Palm Width (mm) Thickness (mm) Min
Cuff (Min) Palm (Min) Finger (Min )
Min Specification Standard SMR Standard SMR Standard SMR
5½ 250 70 ± 6 0.10 0.11 0.10 0.14 0.10 0.16
6 265 76 ± 6
6 ½ 83 ± 6
7 270 89 ± 6
7 ½ 95 ± 6
8 102 ± 6
8 ½ 280 108 ± 6
9 114 ± 6

2. Physical Properties

Characteristics Before Ageing After Ageing 70 ± 2°C for 168 hrs.
ASTM D 3577:2019, IS 13422:1992
Tensile Strength (Mpa) min. 24 18
Ultimate Elongation (%) min. 750 560
Stress at 500% Elongation (Mpa) Max. 5 .5 NA
EN 455-2:2009+A2:2013
Minimum force at break 9.0 N 9.0 N
   
Aqueous extractable protein content
(As per standards ASTM D 3577:2019 )		 < 200 μg/dm² – Test method ASTM D 5712-15 (2020)
Powder content (As per standards ASTM D 3577:2019 ) < 2 mg/ glove– Test method ASTM D 6124-06 (2017)
Sterilization Ethylene Oxide
Sterility Shall pass Sterility test as per IP /USP / EU Pharmacopeia
Labeling Shall comply with government, regulatory and customer requirements

Packing
Packing type:

  • 1 Pair (1 left and 1 right) of gloves per inner wrapper.
  • 1 inner wrapper per pouch.
  • 50 pouches per inner (dispenser) box.
  • 400/ 500 pairs in an outer carton as per customer requirement.
 Shall comply with standard packing and customer requirements

3. Performance Requirements as per ASTM 3577:2019 & EN 455-1;2020, EN 455-2:2009+A2:2013 & EN 455-3:2006

Sampling procedure: ISO 2859 Part-I

Sampling plan:
i. General Inspection Level – For freedom from pinholes
ii. Special Inspection Level – For Physical Dimension and Physical
Properties (Before ageing and after ageing)

Characteristics Inspection Level AQL
Freedom from holes G-1 0.65
Physical Dimensions S2 4.0
Physical Properties S2 4.0
Extractable Protein Content N=3 N/A
Powder amount N=3 N/A
Sterility As per standard N/A