- Creamy white in colour
- Gloves compounded primarily from natural rubber latex (Type-1) for single use.
- Free from dirt marks, oil stains, embedded foreign particles, coagulum, etc.
- Textured at fingertip area.
- The non-sterile latex examination gloves meets the standards BS EN 455-1:2020 , BS EN 455-2 :2015, BS EN 455-3 :2015 ,BS EN 455-4 :2009 , ASTM D 3578:2019
- Ambidextrous fit either hand.
- Lightly powdered with modified absorbable corn starch USP grade.
- The cuff shall fit closely without being constructive and it shall not roll back or ruckle while in use.
- Products have a shelf life of 5 years from the date of manufacturing.
- Each glove has non-detectable levels of chemical residue.
- Nontoxic and non-irritant.
- For single use only.
- Keep the gloves in cool, dry place and away from direct sun light.
- This product contains natural rubber latex which may cause allergic reaction to some individuals. In case of latex allergy discontinues the use and consults a physician.
- After donning, remove powder by wiping gloves thoroughly with a sterile wet sponge, sterile wet towel, or other effective methods.
- Reuse of gloves may cause infection, allergic reactions, and poor barrier protection.
- Any serious incident related to the device should be reported to the manufacturer and the competent authority of the Member State.
- For transient use (normally intended for continuous use for less than 60 minutes).
- Dispose of after use as per hospital policies or the country’s regulatory norms.
Gloves intended for use in the medical field to protect patient and user from cross-contamination, conducting medical examinations, diagnostic and therapeutic procedures and for handling contaminated medical materials.
Size | Length (mm) Min | Palm Width (mm) | Thickness (mm) Min | |
---|---|---|---|---|
Palm | Finger | |||
Extra Small | ≥ 240 | ≤ 80 | 0.08 | 0.08 |
Small | 80 ± 10 | |||
Medium | 95 ± 10 | |||
Large | 110 ± 10 | |||
Extra Large | ≥ 110 |
2. Physical Properties as per BS EN 455-2 : 2015
Characteristics | Before Ageing | After Ageing 70 ± 20 C for 168 hrs. |
---|---|---|
Force at break | ≥ 6 N min | ≥ 6 N min |
Powder content (as per BS EN 455-3 :2015) : min 2mg/ glove
3. Physical Properties as per ASTM D 3578 :2019
Characteristics | Before Ageing | After Ageing 70± 2°C for 166 hrs ± 2hrs. |
---|---|---|
Tensile strength (MPa), Min | 18 | 14 |
Ultimate elongation (%), Min | 650 | 500 |
Stress at 500% (Mpa), Max | 5.5 | NA |
Total protein content (as per ASTM D 3578:2019) : < 200µg/dm²
Powder content (as per ASTM D 3578:2019) : < 10 mg/dm²
Packing & Labeling : Shall comply with the regulatory requirements and customer requirements
Sampling procedure: ISO 2859 Part I Sampling plan
i. General Inspection Level (For freedom from pinholes)
ii. Special Inspection Level (For all other tests)
Characteristics | Inspection Level | AQL |
---|---|---|
Freedom from holes (ASTM D 3578:2019) | G1 | 2.5 |
Freedom from holes (BS EN 455-1:2020) | G1 | 1.5 |
Physical Dimensions | S2 | 4.0 |
Physical Properties | S2 | 4.0 |
Extractable Protein Content | N=3 | N/A |
Powder Content | N=2 | N/A |
Labelling | S2 | 1.5 |
Packing | S2 | 1.5 |
- Creamy white in colour
- Gloves compounded primarily from natural rubber latex (Type-1).
- Free from dirt marks, oil stains, embedded foreign particles, coagulum, etc.
- Textured at fingertip area.
- Powder-free gloves coated with a unique blend of polymer to provide excellent donning capability.
- The non-sterile latex examination gloves meets the standards EN 455-1:2000 , EN 455-2 :2009+ A2 ; 2013, EN 455-3 :2006 , EN 455-4 :2009 , ASTM D 3578:2019
- Ambidextrous fit either hand.
- The cuff shall fit closely without being constrictive and shall not roll back or ruckle while in use.
- Products have a shelf life of 5 years from the date of manufacturing.
- Each glove has non-detectable levels of chemical residue.
- Nontoxic and non-irritant.
- Keep the gloves in a cool, dry place and away from direct sunlight.
- This product contains natural rubber latex, which may cause allergic reactions in some individuals. In case of latex allergy, discontinue use and consult a physician.
- Reuse of gloves may cause infection, allergic reactions, and poor barrier protection.
- Gloves intended for use in the medical field to protect patient and user from cross contamination, conducting medical examinations, diagnostic and therapeutic procedures and for handling contaminated medical materials.
Size | Length (mm) Min | Palm Width (mm) | Thickness (mm) Min | |
---|---|---|---|---|
Palm | Finger | |||
Extra Small | ≥ 240 | ≤ 80 | 0.08 | 0.08 |
Small | 80 ± 10 | |||
Medium | 95 ± 10 | |||
Large | 110 ± 10 | |||
Extra Large | ≥ 110 |
2. Physical Properties as per EN 455-2 : 2009+ A2 ; 2013
Characteristics | Before Ageing | After Ageing 70 ± 2 °C for 168 hrs ± 2hrs. |
---|---|---|
Force at break (N)min. | ≥ 6 N min | ≥ 6 N min |
Total protein content ( as per EN 455-3:2006) : < 200µg/dm²
Powder content (as per EN 455-3:2006) : < 2 mg/glove
3. Physical Properties as per ASTM D 3578:2019
Characteristics | Before Ageing | After Ageing 70± 20 C for 166 hrs ± 2hrs. |
---|---|---|
Tensile strength (MPa), Min | 18 | 14 |
Ultimate elongation (%), Min | 650 | 500 |
Stress at 500% (MPa), Max | 5.5 | NA |
Total protein content (as per ASTM D 3578:2019) : < 200µg/dm²
Powder content (as per ASTM D 3578:2019) : < 2 mg/dm²
Packing & Labeling : Shall comply with the regulatory requirements and customer requirements
Sampling procedure: ISO 2859 Part | Sampling plan
i. General Inspection Level (For freedom from pinholes)
ii. Special Inspection Level (For all other tests)
Characteristics | Inspection Level | AQL |
---|---|---|
Freedom from holes (ASTM D 3578:2019) | G1 | 2.5 |
Freedom from holes (EN 455-1:2000) | G1 | 1.5 |
Physical Dimensions | S2 | 4.0 |
Physical Properties | S2 | 4.0 |
Extractable Protein Content | N=3 | N/A |
Powder Content | N=2 | N/A |
Labelling | S2 | 1.5 |
Packing | S2 | 1.5 |
- 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 colour (Natural).
- Excellent barrier protection due to its extra length preventing cross contamination.
- Free from dirt marks, oil stains, embedded foreign particles, coagulum, etc.
- EO sterilized
- 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.
- Anatomically shaped with micro rough surface in palm and finger area.
- Products have shelf-life of 3 years from the date of manufacturing
- Each glove has non- detectable level of chemical residue.
- Sterilized by validated process.
- Passes Viral Penetration test as per ASTM F 1671
- Biologically compatible as per ISO 10993-Part 5 ,7,10 &11
- Passes Bacterial Endotoxin test as per EN 455-3:2015
- Manufactured in hygienic environment to reduce bio burden level prior to sterilization.
- Keep the gloves in cool, dry place and away from direct sun light.
- Sterile Gloves for single use only. Sterile until package is opened or damaged.
- This product contains natural rubber latex which may cause allergic reaction to some individuals. In case of latex allergy discontinues use and consults a physician.
- Reuse of gloves may cause infection, allergic reaction 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.
- Gloves intended to be worn once and then discarded. The glove is worn on the hand of surgeon and health care 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 for gynaecological and obstetrical use.
Size | Length (mm) min | Width (mm) min | Thickness (mm) min | |||
---|---|---|---|---|---|---|
Finger | Palm | Cuff | ||||
6½ | 14 inch | 350 mm | 83 ± 5 | 0.18 | 0.16 | 0.11 |
16 inch | 400 mm | |||||
18 inch | 450 mm | |||||
7½ | 14 inch | 350 mm | 95 ± 5 | 0.18 | 0.16 | 0.11 |
16 inch | 400 mm | |||||
18 inch | 450 mm | |||||
8½ | 14 inch | 350 mm | 108 ± 6 | 0.18 | 0.16 | 0.11 |
16 inch | 400 mm | |||||
18 inch | 450 mm |
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 455-2:2015 | ||
Minimum force at break | 9.0 N | 9.0 N |
Sterilization (for sterile product) | Ethylene Oxide | |
Sterility | Shall pass Sterility test as per US/ IP/EU Pharmacopeia | |
Packing
|
Shall comply with standard packing and customer requirements | |
Labeling | Shall comply with government regulatory requirement for and customer requirements |
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 |
Sterility | N=5 | N/A |
Labelling | S2 | 1.5 |
Packing | S2 | 1.5 |